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Induction and Augmentation of Labour Guideline July 2017

Induction and Augmentation of Labour Guideline July 2017 of 28

Document Control

Title

Induction and Augmentation of Labour Guideline

Author

Author’s job title Consultant Obstetrician, Labour Ward Lead Lead Clinical Midwife

Directorate Womens and Childrens

Department Maternity

Version Date

Issued Status Comment / Changes / Approval

0.1 May 2017

Draft Initial version for consultation; this new guideline replaces the previous ‘Induction of Labour’ guideline and the ‘Use of Oxytocin’ guideline

1.0 July 2017

Final Approved by Maternity Guidelines group

Main Contact Ladywell Unit North Devon District Hospital Raleigh Park Barnstaple, EX31 4JB

Tel: Direct Dial – 01271 322577 Tel: Internal – 4036

Lead Director Director of Clinical Services

Superseded Documents Induction of Labour’ guideline and the ‘Use of Oxytocin’ guideline

Issue Date July 2017

Review Date July 2020

Review Cycle Three years

Consulted with the following stakeholders: (list all)

All users of this document? Additional transferred group staff /stakeholders

Approval and Review Process

Maternity Guidelines Group

Local Archive Reference G:\OBSGYNAE\Risk\Archives\Maternity Services Local Path Guidelines folder Filename Induction and Augmentation of Labour Guideline

Policy categories for Trust’s internal website (Bob) Maternity

Tags for Trust’s internal website (Bob) Syntocinon Oxytocin Infusion Propess ARM Sweep Cooks Balloon



CONTENTS

Document Control........................................................................................................................ 1

1. Purpose ................................................................................................................................ 2

2. Definitions............................................................................................................................ 3

3. Responsibilities .................................................................................................................... 3

4. Induction of Labour .................................................................... Error! Bookmark not defined.

Low risk Pregnancies; Process and Monitoring ................................................................................

High risk Pregnancies; Process and Monitoring.............................. Error! Bookmark not defined.

5. Augmentation of Labour .........................................................................................................

First Stage of Labour augmentation .................................................................................................

Second stage of labour Augmentation .............................................................................................

6. Methods of induction and augmentation of labour………………………………………………………………….

Monitoring Compliance with and the Effectiveness of the Guideline ........................................... 11

Standards/ Key Performance Indicators ....................................................................................... 19

Process for Implementation and Monitoring Compliance and Effectiveness .............................. 19

7. References ......................................................................................................................... 20

8. Associated Documentation ................................................................................................. 21

Appendices

1. Purpose

1.1. The purpose of this document is to detail the process for induction of labour. Induction of labour is a relatively common procedure. Every year in the UK approximately 20-25% of labours are induced. It is recognised that Induction of labour has an impact on birth experience and the health of women and their babies. It may be less efficient, increase risk and can be more painful than spontaneous labour. Therefore it needs to be clinically justified. The decision should be made when the interests of the mother or baby, or both, are better served by inducing labour or continuing the pregnancy (NICE, 2008).

1.2. The policy applies to midwives and Obstetricians with appropriate training only. Those who have not been trained to use the induction or augmentation methods should seek the skills to do so and in the meantime ask an appropriately trained colleague to undertake the intervention.

1.3. Implementation of this policy will ensure that augmentation or induction of labour at NDDH

follows an evidence based sequence of methods; based on national guidance, manufacturer recommendations or local needs ( e.g. outpatient induction is not available due to geographical distance)

is recommended based on clearly documented clinical rationale and undertaken by appropriately trained clinicians

is timebound with a clearly documented timeframe for each method and a ‘latest expected delivery date’.



2. Definitions

Definition

2.1. .(Augmentation of labour: Re-define please). Confirmation is achieved via cervical assessment and assessment of contractions (frequency and duration) (WHO, 2014).

Delay of established labour in the first stage is defined as <1cm per hour for multiparous women and <05.cm for nulliparous women (NICE, 2017).

2.2. Induction of labour is the use of artificial means to initiate labour to avoid increased risk to maternal or fetal morbidity or mortality. This may be due to risks associated with prolonged pregnancy, prolonged rupture of membranes, pregnancy associated complications or risks associated with long term conditions such as maternal diabetes.

2.3. NDDH – North Devon District Hospital ARM – Artifical Rupture of Membranes

3. Responsibilities

Role of the Midwife

3.1. The Midwife is responsible for:

Acting as an effective advocate for women thereby ensuring that women have appropriate information with which to make an informed choice about induction or augmentation of labour.

Ensuring that all women with low risk pregnancies are offered a membrane sweep within guidance to avoid prolonged pregnancy.

Ensuring that all women with low risk pregnancies are offered a date for induction of labour in keeping with guidance to avoid prolonged pregnancies.

Ensuring that all women with high risk pregnancies have an appointment with an Obstetrician to make a decision about induction of labour.

Ensuring that all women with high risk pregnancies are offered a date for induction of labour in keeping with guidance for their specific risk factors.

Role of the Obstetrician

3.2. The Obstetrician is responsible for:

Ensuring that women have appropriate information with which to make an informed choice about induction or augmentation of labour.

Ensuring that a full discussion is undertaken and clearly documented including; the reason for induction or augmentation,



the risks and benefits of the process, the proposed methods to be used, a timebound plan which is clearly written for all staff involved in

the process to refer to (this will clearly state the timings for each stage and an expected date of delivery if all methods fail).

N.B. Using Induction of Labour Decision Sticker in Appendix C

Ensuring that all women with low risk pregnancies are offered a membrane sweep within guidance to avoid prolonged pregnancy.

Ensuring that all women with low risk pregnancies are offered a date for induction of labour in keeping with guidance to avoid prolonged pregnancies.

Ensuring that all women with high risk pregnancies have an appointment with an Obstetrician to make a decision about induction of labour.

Ensuring that all women with high risk pregnancies are offered a date for induction of labour in keeping with guidance for their specific risk factors.

4. Induction of labour

4.1. Induction of labour at NDDH will be undertaken for two reasons; in low risk pregnancies to avoid prolonged pregnancy, in high risk pregnancies where the benefits of induction outweigh the

assessed risks factors. This will include; previously low risk pregnancies now complicated by risk factors

such as pre-labour rupture of membranes or prematurity, high risk pregnancies complicated by pregnancy associated

conditions or risks associated with long term conditions.

4.2. The decision to induce labour will be made by the woman and a senior Obstetrician (SAS grade or Consultant).

Low risk pregnancies

Process

4.3. All women with low risk pregnancies will be offered an induction of labour to avoid prolonged pregnancy from 41+6 weeks gestation.40+13 is too late, to my opinion, I would prefer to stay at 40+11. Please see Appendix A for a quick reference guide to Induction of Labour for low risk pregnancies.

4.4. The woman should be informed by 40 weeks gestation of the risks associated with prolonged pregnancy and the options to avoid this. The Induction of Labour leaflet should be given and the woman should be offered a membrane sweep.

4.5. At 41 weeks gestation the woman should be offered a membrane sweep which can be repeated again after 48 hours to a maximum of three membrane sweeps in total from 40 weeks gestation to 41+6 weeks gestation.



4.6. At 41+3 weeks gestation a booking should be made with the hospital for an induction date at 41+6 weeks gestation.

4.7. At 41+6 weeks gestation the woman should be admitted to hospital for induction. The on-call Obstetrician (SAS Grade or Consultant) must ensure a full discussion is completed (It is unnecessary, as is clear in the guideline what to do. Practically, it is not possible to see and document all low risk women for postdate induction by medical staff. Explanation about IOL should be carried out by CMW and on admission by MW. SAS/Consultant can be involved from day 3 if not ARMable.) and clearly documented including; the reason for induction or augmentation, the risks and benefits of the process, the proposed methods to be used, a timebound plan which is clearly written for all staff involved in the

process to refer to. This will clearly state the timings for each stage and an expected date of delivery if all methods fail.


4.8. Induction of labour for low risk pregnancies to avoid prolonged pregnancy will follow the following timebound sequence; Day 1 – assessment using Bishops Score system (see Appendix C)

If the Bishops Score is <7 then insertion of a cervical ripening balloon should be completed, please see Chapter 5 for specific guidance on this method. Balloon to remain in situ for 12 hours.

If the Bishops Score is ≥7 then ARM followed by Syntocinon infusion should be completed, please see Chapter 5 for specific guidance on this method.

Day 2 – assessment using Bishops Score system. If the Bishops Score is <7 then insertion of slow release

prostaglandin pessary (Propess 10mg) should be completed, please see Chapter 5 for specific guidance on this method. Propess to remain in situ for 24 hours.


Day 3 – assessment using Bishops Score system. If the Bishops Score is ≥7 then ARM followed by Syntocinon

infusion should be completed, please see Chapter 5 for specific guidance on this method.

If the Bishops Score is <7 then a full discussion should be undertaken with the woman and a Consultant Obstetrician regarding mode of delivery. A clear plan for time of delivery should be documented which should not exceed 42+2 weeks gestation.

Day 4 - Maximum delivery date goal is reached. The woman is now 42+2 weeks gestation and a clear plan for delivery must be made with a full discussion.



4.9. If induction is declined by the woman she should be offered twice weekly outpatient CTG and USS assessment (from when?) to include measurement of liquor volume and uterine dopplers. A full discussion should be undertaken and clearly documented in the maternity records with a clear management plan.

Low risk pregnancies

Monitoring

Induction of labour for low risk pregnancies to avoid prolonged pregnancy can be undertaken on the Day Assessment unit or Ante/Potsnatal ward.

Prior to commencing Induction of labour with cervical balloon or Propess; Facilities should be available for continuous electronic fetal heart rate

and uterine contraction monitoring using a CTG machine. Maternal observations should be recorded. Normal fetal heart rate pattern should be confirmed by CTG for a period

no less than 30 minutes using an NDDH Fresh Eyes Antepartum CTG assessment sticker.

Following insertion; CTG recording should continue with a normal fetal heart rate pattern for

a period no less than 30 minutes using an NDDH Fresh Eyes Antepartum CTG assessment sticker.

During admission for Induction of labour with cervical balloon or Propess; 4 hourly fetal heart rate and movements- commence a CTG if any fetal

heart rate abnormalities are detected. 4 hourly uterine activity, vaginal loss. 4 hourly maternal observations recorded on the MEOWS chart and

followed in accordance with PAR policy. Assess and record any systemic effects (e.g. nausea, vomiting).

Under no circumstances is discharge recommended at any stage during the induction of labour process.

Induction of labour is only recommended for clinically indicated rationale and by this very definition the goal of induction, delivery, must be reached before discharge is clinically recommended.

Once the woman has been admitted, a clear plan with timeline for delivery is made and this will not include discharge for any reason.

Prior to commencing Induction of labour by ARM or Oxytocin infusion; Facilities should be available for continuous electronic fetal heart rate



Following ARM;



CTG recording should continue with a normal fetal heart rate pattern for a period no less than 30 minutes using an NDDH Fresh Eyes Intrapartum CTG assessment sticker.

Following commencement of Oxytocin infusion; Continuous CTG. Follow Intrapartum and Fetal Monitoring guidelines.

High risk pregnancies

Process

4.10. All women with high risk pregnancies will be offered early induction of labour (pre 41+5 weeks gestation) where the benefits of induction outweigh the assessed risks factors. This will include; previously low risk pregnancies now complicated by risk factors such as

pre-labour rupture of membranes or prematurity, high risk pregnancies complicated by pregnancy associated conditions or

risks associated with long term conditions. Please see Appendix B.

4.11. The timing of the induction will be agreed by the woman and a senior Obstetrician (SAS grade or Consultant) based on the risks associated with the pregnancy or long term conditions. Please see Appendix B for specific details.

4.12. The Obstetrician (SAS Grade or Consultant) must ensure a full discussion is completed and clearly documented including; the reason for induction or augmentation, the risks and benefits of the process, the proposed methods to be used, a timebound plan which is clearly written for all staff involved in the

process to refer to. This will clearly state the timings for each stage and an expected date of delivery if all methods fail.


4.13. Induction of labour for high risk pregnancies will follow an individualised timebound sequence; maternal/fetal risk factors will determine the time allowed for induction of labour before delivery must be undertaken.

The steps for Induction of labour for high risk pregnancies will be clearly documented in the woman’s notes with a clearly defined timeframe for each step. They may include any or all of the following; Day 1 Step 1 – assessment using Bishops Score system.

If the Bishops Score is <7 then insertion of a cervical ripening balloon should be completed, please see Chapter 5 for specific guidance on this method. Balloon to remain in situ for 12 hours.


Day 2 Step 2 – assessment using Bishops Score system.



If the Bishops Score is <7 then insertion of slow release prostaglandin pessary (Propess 10mg) should be completed, please see Chapter 5 for specific guidance on this method. Propess to remain in situ for 24 hours.


Day 3 Step 3 – assessment using Bishops Score system. If the Bishops Score is ≥7 then ARM followed by Syntocinon

infusion should be completed, please see Chapter 5 for specific guidance on this method.

If the Bishops Score is <7 then a full discussion should be undertaken with the woman and a Consultant Obstetrician regarding mode of delivery. A clear plan for time of delivery should be documented which should not exceed 42+2 weeks gestation.

Day 4 Step 4 - Maximum delivery date goal is reached. The woman is now 42+2 weeks gestation and a clear plan for delivery must be made with a full discussion.

Not applicable for high risk women.Monitoring Induction of labour for high risk pregnancies will take place in hospital , the location will be assessed by the Band 7 co-ordinator and Consultant on call based on maternal/fetal risk factors and clinical activity and acuity.

Prior to commencing Induction of labour with cervical balloon or Propess; Facilities should be available for continuous electronic fetal heart rate



Following insertion; CTG recording should continue with a normal fetal heart rate pattern for

a period no less than 30 minutes using an NDDH Fresh Eyes Antepartum CTG assessment sticker.

During admission for Induction of labour with cervical balloon or Propess; 4 hourly fetal heart rate and movements(that should be individualised)-

commence a CTG if any fetal heart rate abnormalities are detected. 4 hourly uterine activity, vaginal loss. 4 hourly maternal observations recorded on the MEOWS chart and

followed in accordance with PAR policy. Assess and record any systemic effects (e.g. nausea, vomiting).

Under no circumstances is discharge recommended at any stage during the induction of labour process.



Induction of labour is only recommended for clinically indicated rationale and by this very definition the goal of induction, delivery, must be reached before discharge is clinically recommended.

Once the woman has been admitted, a clear plan with timeline for delivery is made and this will not include discharge for any reason.

High risk pregnancies

Monitoring cont’d

Prior to commencing Induction of labour by ARM or Oxytocin infusion; Facilities should be available for continuous electronic fetal heart rate



Following ARM; CTG recording should continue with a normal fetal heart rate pattern for

a period no less than 30 minutes using an NDDH Fresh Eyes Intrapartum CTG assessment sticker.

Following commencement of Oxytocin infusion; Continuous CTG. Follow Intrapartum and Fetal Monitoring guidelines.

5. Augmentation of labour

5.1. (Repetitive!)Augmentation of labour is the confirmed delay of established labour in the first or second stages. Confirmation is achieved via cervical assessment and assessment of contractions (frequency and duration) (WHO, 2014).

5.2. (Repetitive!)Delay of established labour in the first stage is defined as <1cm per hour for multiparous women and <05.cm for nulliparous women (NICE, 2017).

5.3. (Should go under second stage of labour augmentation heading)Delay of established labour in the second stage with a view to augmentation will be assessed by a SAS grade Obstetrician based on the assessment of contractions prior to full dilatation and descent of the presenting part. Contractions must not exceed 4-5 per 10 minutes regardless of descent of the presenting part.

First stage of labour augmentation.

5.4. In the first stage of labour augmentation may be undertaken using two methods; ARM and Oxytocin infusion.

5.5. Cervical assessment will diagnose delay of established labour and ARM should be undertaken with consent as a first line response. Please see Chapter 5 for specific guidance on this method. The woman will be re-assessed after two hours for assessment for further intervention with an oxytocin infusion.



5.6. If the membranes are already ruptured on diagnosis of delay in established labour an oxytocin infusion should be commenced. Please see Chapter 5 for specific guidance on this method.

5.7. The condition of the mother and fetus must be carefully assessed, including a clearly documented cervical assessment before commencing Oxytocin. Oxytocin must not be commenced without a fully documented Obstetric (Staff Grade or Consultant) assessment and plan, with the appropriate prescription.

5.8. Continuous electronic fetal monitoring is necessary whilst the oxytocin infusion is in progress. If the fetal monitoring trace becomes abnormal, STOP the oxytocin infusion.

5.9. Aim for regular contractions 4-5:10 minutes, NO MORE THAN 5:10. (VBAC 3-4:10). Do not rely on the external transducer to monitor contractions –you MUST manually palpate the frequency, strength of and rest time between contractions.

5.10. Once the oxytocin infusion is commenced, a vaginal examination will take place maximum four hours after the onset of regular contractions 4-5:10 OR six hours after commencing oxytocin, whichever time is reached first. This timeframe will need to be individualised to the cervical assessment at commencement of the oxytocin infusion as well maternal/fetal risk factors.

5.11. Progress in labour with an oxytocin infusion is defined as 0.5cm per hour for nulliparous women and 1cm per hour for multiparous women. Careful attention should be paid to the defined progress; where there is delayed progress and an oxytocin infusion in use a clear Obstetric plan must be documented with frequent (minimum two hourly) reviews.

Second stage of labour augmentation.

5.12. Augmentation during the second stage of established labour may be considered following discussion between the staff grade Obstetrician and Consultant Obstetrician, and with informed consent of the woman.

5.13. In the second stage of labour augmentation may be undertaken using two methods; ARM and Oxytocin infusion.

5.14. Cervical assessment will diagnose delay and ARM should be undertaken with consent as a first line response. Please see Chapter 5 for specific guidance on this method. The decision to commence an oxytocin infusion following ARM in the second stage must be carefully considered allowing; enough time (How long is enough time?)for the effect of the ARM on contractions to be assessed, assessment of maternal and fetal risk factors, assessment of contractions NO MORE THAN 5:10. (VBAC 3-4:10).



5.15. If the membranes are already ruptured on diagnosis of delay in established labour an oxytocin infusion should be commenced. Please see Chapter 5 for specific guidance on this method.

5.16. The condition of the mother and fetus must be carefully assessed, including a clearly documented cervical assessment before commencing Oxytocin. Oxytocin must not be commenced without a fully documented Obstetric (Staff Grade or Consultant) assessment and plan, with the appropriate prescription.

5.17. Continuous electronic fetal monitoring is necessary whilst the oxytocin infusion is in progress. If the fetal monitoring trace becomes abnormal, STOP the oxytocin infusion.

5.18. Aim for regular contractions 4-5:10 minutes, NO MORE THAN 5:10. (VBAC 3-4:10). Do not rely on the external transducer to monitor contractions –you MUST manually palpate the frequency, strength of and rest time between contractions.

5.19. Once the oxytocin infusion is commenced, ensure there is (that was already discussed for the guideline ”Intrapartum care”. Needs clear individualised care plan.This timeframe will need to be individualised to the cervical assessment at commencement of the oxytocin infusion as well maternal/fetal risk factors.

5.20. If tachysystole (please describe under “definition” heading No:2) is suspected, REDUCE the infusion rate. If hyperstimulation (please describe under “definition” heading No:2) is suspected – STOP the infusion. Immediate Obstetric assessment is required and you may wish to consider subcuticular Terbualine 0.25mg.

6. Methods of induction and augmentation of labour

6.1. Please describe Contraindication for IOL in general and contraindication for each method separately.

Membrane sweep(please describe under “definition” heading No:2)

Membrane sweeping, sometimes referred to as stripping or stretch and sweep of the membranes, is a relatively simple labour stimulation technique. Used by midwives or obstetricians, its intent is to initiate the onset of labour physiologically. This promotes normality and avoids the need for formal induction of labour for prolonged pregnancy using prostaglandins, artificial rupture of membranes and oxytocin (Boulvain et al, 2005).



To perform a membrane sweep, the examining fingers during a vaginal examination are introduced into the cervical os and passed circumferentially around the cervix (Boulvain et al, 1998). This should separate the membranes from their cervical attachment. This process of detaching the membranes from the decidua results in the release of local prostaglandins (Mitchell et al, 1977). This in turn will increase the probability of the onset of labour within 48 hours and of being delivered within one week (Keirse, 1995; McColgin et al, 1990; Weissberg and Spellacy, 1977). Massage of the cervix, around the vaginal fornices, can be used when the cervical os remains closed. This may also cause the release of local prostaglandin (Rogers, 2010). The process can be repeated if labour does not start spontaneously after an appropriate time period, typically 36 hours.

At NDDH, a membrane sweep is recommended for all women with low risk pregnancies from 40 weeks gestation to 41+5 weeks gestation with a maximum of three sweeps given in total.

Women with high risk pregnancies will need to have an individualised risk assessment by a senior Obstetrician (SAS Grade or Consultant) and may be considered appropriate for a membrane sweep.

Cervical Ripening balloon

Induction of labour using a cervical ripening balloon is undertaken at NDDH using the Cook Medical Cervical ripening balloon catheter (CRB) which is a silicone double balloon catheter. Please see Appendix D for further information about the Cook balloon and insertion technique.

Indications see above 6.1

All women with low risk pregnancies at term undergoing Induction of labour to avoid prolonged pregnancy.

Some women with high risk pregnancies at term who are undergoing induction of labour where the benefits of induction outweigh the maternal and/or fetal risks associated with pregnancy related or long term conditions. This will include women with Reduced Fetal Movements, Diabetes, PET, babies who are SFGA (Not IUGR), women who want to have VBAC with a previous lower segment incision (although the product is not currently licensed for this use, the technique is used nationally). Please see Appendix B for clarity.

Contraindications see above 6.1

NEVER use simultaneously with prostaglandins or oxytocin. This will increase the risk of fetal compromise, uterine rupture, haemorrhage, amniotic fluid embolism and retained placenta.

Fetal Feto-Maternal

Maternal



Presenting Part above pelvic inlet

Malpresentation

Non-reassuring or abnormal CTG

Absent or reversed EDF on Doppler

Severe IUGR

Low lying placenta

Placenta praevia

Vasa praevia

Any contraindication to vaginal birth

No consent Previous Classical C- section

Active herpes lesions / HIV Polyhydraminos

Ruptured membranes Multiple pregnancy

Severe maternal pre eclampsia

History of myomectomy where there is full thickness incision

Already having regular uterine contractions

Process for insertion of cervical ripening balloon

Prepare all equipment required for the procedure on a clean procedure trolley prior to establishing a sterile field and using an aseptic technique.

Prior to insertion: Confirm gestational age, singleton pregnancy(Why not multiple

pregnancy?), vertex presentation, intact membranes, exclude placenta praevia and any contraindications to vaginal birth

A CTG must be performed for 30 minutes before CRB insertion. Perform an abdominal palpation to confirm presentation and vaginal

examination to obtain a Bishop’s score (unfavourable cervix and ARM not feasible)

Ensure the woman has emptied her bladder. Confirm maternal pulse, blood pressure, respiration rate and uterine

activity meet accepted criteria for induction.

Insertion of balloon: (see Appendix D for diagrams) Verbal consent to the procedure Perform a VE and record the Bishop’s score. Insert 2 fingers into the

vagina, then using the other hand to guide, gently advance the CRB through the cervix until both balloons have entered the cervical canal.

Inflate the uterine balloon with 20-40ml of saline through the catheter valve U. Once the uterine balloon is inflated, pull the device back until the balloon abuts the internal cervical os.

Time the placement of the balloon so that it is in place no longer than 12 hours before active labour is induced.

Once it is confirmed that the lower vaginal balloon is now outside the external os, inflate the vaginal balloon catheter valve V with 20ml saline.

Once the balloons are situated on either side of the cervix, add saline (slowly in 20ml increments) - a maximum of 80mL per balloon.

You may allow the catheter to hang down loosely or tape it to the side of the thigh if deemed more comfortable.

A Cusco speculum can be used to visualise the cervix if digital examination is not successful



Using a rampley’s sponge holder advance the catheter through the cervix until the balloons have passed the internal os.

Inflate as described above.

After insertion;

Repeat CTG for at least 30 minutes after insertion

Allow to mobilise if CTG is normal If there is any evidence of CTG(Abnormal CTG), then the balloon should

be removed and a VE performed

Observations during admission following Insertion of cervical balloon; 4 hourly fetal heart rate and movements(No CTG for high risk IOL?)-

commence a CTG if any fetal heart rate abnormalities are detected. 4 hourly uterine activity, vaginal loss, pulse and blood pressure.

Assess and record any systemic effects (e.g. nausea, vomiting). Further vaginal examinations are unnecessary unless regular contractions

are established or SROM occurs. N.B. perform CTG at this time.

Indications for catheter removal include:

Ruptured membranes

Uterine hyperstimulation or uterine tachystole

Abnormal CTG requiring urgent delivery Urinary retention - remove some or all fluid from the balloon(s)

Maximum recommended time reached

Management after insertion Remove the CRBC after 12 hours and perform a VE to assess suitability

for ARM. Allow women to mobilise for 2 hrs after removing the CRB

before attempting ARM ARM should be performed in labour ward and the management of labour

should be conducted as per VBAC guideline.

To remove the cervical balloon; Deflate both balloons through the corresponding valve marked U and V

and remove it vaginally The balloon may fall out as the cervix dilates prior to 12 hours time limit

If the membrane ruptures while the catheter in in situ, then the catheter should be removed and VE performed to exclude cord prolapse.

If there is evidence of uterine hypercontractility with CTG abnormalities, the balloon should be deflated and device removed

If despite using the cervical balloon the cervix is still unfavourable for ARM, then



further management should be discussed with the consultant on call. Consideration should be given to performing a caesarean section.

Prostaglandin pessary

At NDDH the prostaglandin pessary in use is Propess which is a slow release vaginal pessary containing 10mg Dinoprostone. Propess releases prostaglandin at a steady rate of 0.3 mg/hr for up to 24 hours, and has a half life of 1-3 minutes. Studies have shown that Propess is as effective as existing methods of induction of labour using prostaglandin preparations (Kelly et al 2003, NICE 2008). Whilst using Propess, women may require fewer vaginal examinations, have a reduction in IOL – delivery time and less time spent in the antenatal ward awaiting IOL.

Indications for use of Propess pessary All pregnancies suitable for induction of labour all low risk pregnancies to avoid prolonged pregnancy all high risk pregnancies where there are no contraindications as stated

below

Contraindications for use of Propess pessary Bishops Score >7 Abnormal antenatal CTG Malpresentation Abnormal placentation Multiple pregnancy (why propess should not be used) Prematurity (unless in the rare event there are significant benefits to

premature delivery)(Why propess should not be used) Regurlar contractions Bleeding

spontaneous rupture of membranes (SROM) )(Why propess should not be used)

Prior to administration of Propess pessary Remove Propess pessary from freezer 5 – 10 minutes before use Assess Bishop Score If Bishop’s Score < 7 – insert Propess pessary

Technique (see Appendix D for diagrams)

A Propess pessary should be inserted into the posterior fornix and rotated into a transverse position behind the cervix.

Holding the Propess insert between the index and middle fingers of the examining hand, insert it high into the vagina towards the posterior vaginal fornix using only small amounts of water soluble lubricants.



The index and middle fingers should now be twisted a quarter turn clockwise, pushing the Propess insert higher up, behind the posterior fornix and turning it through 90o so that it lies transversely in the posterior fornix.

Carefully withdraw the fingers leaving the Propess in situ. After insertion ensure that the patient remains recumbent for 20-30 minutes to allow time for the Propess insert to swell. Again, this will help it to remain in place for the duration of the treatment. Allow sufficient tape to remain outside the vagina to permit easy retrieval.

After Propess pessary insertion Women should remain in bed, in a semi-recumbent position for

approximately 1 hour post insertion. Following CTG monitoring for a minimum of 30 minutes, women may

mobilise after 1 hour, as they wish. Women should be reminded to take care when going to the toilet, not to

pull on the tape and detach the pessary. Women should inform the midwife at the onset of painful regular

contractions. Propess should be unaffected by bathing and showering although women

should be advised against excessive use of soap Observations during admission following Insertion of the Propess pessary;

4 hourly fetal heart rate and movements (???)- commence a CTG if any

fetal heart rate abnormalities are detected. 4 hourly uterine activity, vaginal loss, pulse and blood pressure. Further vaginal examinations are unnecessary unless regular contractions

are established or SROM occurs. N.B. perform CTG at this time.

Assess and record any systemic effects (e.g. nausea, vomiting).

When to remove Propess pessary A Propess pessary is designed to remain in the vagina for up to 24 hours.

To remove Propess, apply gentle traction on the retrieval tape (the insert will have swollen to 2-3 times its original size and be pliable). Document in the maternal notes the time of removal.

However it should be removed immediately in the following instances; Regular contractions establish and the cervix is dilated greater than 3 cm Vaginal bleeding. Fetal compromise – CTG becomes pathological. If rupture of membranes occurs subsequent to administration of Propess Uterine hyperstimulation (rare, but can occur) Tachsystole At least 30 minutes prior to starting an intravenous infusion of oxytocin. Adverse maternal systemic reaction – severe nausea or vomiting (rare).



Routine removal after 24 hours Remove Propess after 24 hours and perform vaginal examination Transfer to Labour ward if ARM is possible, or if in active labour

If despite using the Propess pessary the cervix is still unfavourable for ARM, then further management should be discussed with the consultant on call. Consideration should be given to performing a caesarean section.

ARM

ARM is the rupture of the amnion and chorionic membranes that surround the fetus, encasing it in a sac of amniotic fluid. It is performed by the use of a crotchet-like, long-handled hook passed per vaginum (commonly referred to as an amnio-hook). Please go to “Definitions”

An abdominal palpation and vaginal examination should be completed to determine suitability for ARM. A Bishops Score or Vaginal Examination tool should be completed.

Contraindications to ARM are; Known or suspected vasa previa

Any contraindications to vaginal delivery Unengaged presenting part (although this may be appropriate using controlled ARM in theatre with the appropriate measures in place if immediate delivery is required as a result of the ARM.)

Technique

With consent use the fore and middle fingers to enter the vagina in the same process as for vaginal examination. Using an amniotic hook, the handle of the device is held with one hand outside the vagina while the two fingers of the opposite hand are in the vagina to guiding the tip towards the open cervix. Care should be taken to protect maternal tissues from the point. Once the hook reaches the amniotic sac, the tip is pushed up against the sac with the index or middle finger of the internal hand to pierce the membranes. The hook is then pulled through the membranes with the external hand holding the handle to create a hole in the sac.

The examining hand should remain in place to confirm that there has been no prolapse of the umbilical cord during the ARM. The hand is then removed from the vagina. The nature of the amniotic fluid (ie, clear, bloody, meconium-stained) is documented and the fetal heart rate should be monitored continuously for 30



minutes after the procedure. ARM with oxytocin should not be used as a primary method of induction of labour unless there are specific contraindications to other methods or cervix is favourable

( Bishop’s score > 7 ).

At NDDH, an Oxytocin infusion will be commenced after an ARM as follows:

In primiparous women; immediately after ARM.

In multiparous women; within two hours of an ARM if labour is not established.

Oxytocin infusion

Pre-labour or Intrapartum indications for oxytocin use; Augmentation; delay in the first stage of established labour. Induction of labour process; as part of the documented Obstetric plan which

will include (as appropriate) membrane sweep, prostaglandins and artificial rupture of membranes.

Augmentation during the second stage of established labour may be considered following discussion between the staff grade Obstetrician and Consultant Obstetrician, and with informed consent of the woman. Ensure there is ongoing review every 15-20 minutes by an obstetrician

VBAC; the decision to use an oxytocin infusion and the frequency of increment should be discussed with the woman by a Consultant Obstetrician.

Pre-labour or Intrapartum contraindications for use; Lack of informed consent from the woman Intact membranes, Bishops score <7, Contractions >4-5:10 minutes Hyperstimulation or tachysystole, Abnormal fetal monitoring trace Within six hours of prostaglandin tablet or 30 minutes after Propess removal.

Oxytocin infusion Dose schedules and frequency of increment

Syntocinon 30 international units added to 500ml of Normal Saline, contents thoroughly mixed.

Time after starting (mins) Syntocinon dose (milliunits per min) Volume infused (mls per hr)

0 1 1

30 2 2

60 4 4

90 8 8



120 12 12

150 16 16

180 20 20

210 24 24

240 28 28

270 32 32

Maximum licensed dose is 20 milliunits per minute.

Contact the obstetrician if contractions < 4-5:10 at 20 milliunits per minute.

Doses above 20 milliunits should be prescribed upon the infusion medication chart.

Dose of Syntocinon should not exceed 32 milliunits per minute.

7. Monitoring Compliance with and the Effectiveness of the Guideline

Standards/ Key Performance Indicators

7.1. Key performance indicators comprise: Documentation; the reason for induction or augmentation, the risks and

benefits of the process, the proposed methods to be used and a timebound plan.

Outcome Length of time from commencement to delivery Maternal and Fetal observations Feedback from the women

Process for Implementation and Monitoring Compliance and Effectiveness

7.2. The cervical ripening balloon implementation process will commence with training, a trial of the new process and ratification of the guidance following review of the trial results.

7.3. The Induction and Augmentation of Labour Guideline implementation process will commence following ratification at the Maternity Guidelines meeting. New aspects of the guideline will be disseminated in practice and staff training.

7.4. The monitoring process:

An annual audit of at least 100 sets of maternity records will be undertaken monitoring the following elements:

Indication for IOL Outcome Length of time from commencement to delivery



Maternal and Fetal observations Feedback from the women

A report will be produced yearly, presented at labour ward forum & circulated to all medical staff . It will also be submitted alongside an Audit Outcome Form to the Health group Quality Facilitator.

Any identified deficiencies will be discussed at Labour ward Forum and a timeframe for actions agreed. Completion of these actions will be identified through Labour Ward Forum Required changes to practice will be identified and actioned within the time frame identified through Labour Ward Forum. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders.

8. References

Cook Medical – Cervical ripening balloon Product information

Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z (2010). Different methods for the

induction of labour in outpatient settings Cochrane Database of Systematic Reviews

Issue 8.

Haugland B, Albrechtsen S, Lamark E, Rasmussen S, Kessler,J (2013) Induction of labor

with single- versus double-balloon catheter - a randomized controlled trial Poster

Presentation www.mednet.no/nfog2012/abstractbook/files/assets/.../page0126.pdf

Henry A, Madan A, Reid R,Tracy S, Austin K, Welsh A, Challis D (2013) Outpatient Foley

catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial

BMC Pregnancy and Childbirth. 13:25

Jozwiak M, Oude RK, Benthem M, van BE, Dijksterhuis MG, deGraaf IM, et al

(2011) Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term

(PROBAAT trial): an open-label,randomised controlled trial. Lancet 2011;378:2095–103.

Kelly AJ, Kavanagh J, Thomas J. Vaginal prostaglandin (PGE2 and PGF2a) for induction of

labour at term. The Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.:

CD003101. DOI:10.1002/14651858.CD003101

Lyrenas Sven et al., In vivo controlled release of PGE2 from a vaginal insert (0.8mm,

10mg) during induction of labour, BJOG, February 2001,Vol. 108, pp169-178.

National Institute for Clinical Excellence (2008) Induction of Labour

http://guidance.nice.org.uk/CG70/QuickRefGuide/pdf/English

National Institute for Clinical Excellence (2011) Multiple pregnancy: antenatal care for

twin and triplet pregnancies [C129]

National Institute for Clinical Excellence (2015) Insertion of double balloon catheter for

induction of labour in pregnant women without previous caesarean section. NICE

interventional procedure guidance [IPG528]



Nursing and Midwifery Council (2009) Record Keeping: Guidance for nurses and

midwives

Nursing and Midwifery Council (2004) Midwives rules and standards. NMC London

Nursing and Midwifery Council (2008) The Code: standards of conduct, performance and

ethics for nurses and midwives. NMC London

Singh A, Cheong PWK, Jain A & Penna L. The use of the Cook’s Cervical Ripening Balloon

for induction of labour in women with a previous Caesarean section. Kings College

Hospital, UK.2010

Vaknin Z, Kurzweil Y, Sherman D (2010) Foley catheter balloon vs locally applied

prostaglandins for cervical ripening and labor induction: a systematic review and

meta-analysis. American Journal of Obstetrics and Gynecology 203: 418-29

Van Baaren GJ, Jozwiak M, Opmeer BC, et al (2013) Cost-effectiveness of induction of

labour at term with a Foley catheter compared to vaginal prostaglandin E₂ ge (PROBAAT

trial). British Journal of Obstetrics and Gynaecology 120 (8): 987-995

9. Associated Documentation Appendix A

Low Risk Pregnancies Induction of Labour flowchart



Appendix B

High Risk Pregnancies/ specific circumstances for EARLY IOL

DIABETES VBAC

Offer Membrane sweep 40/41/41+3 weeks gestation Discuss Induction of Labour 40/41 weeks gestation

Book IOL 41+3 weeks Admit for IOL 41+5 weeks

All post dates to have cervical ripening balloon catheter (unless contra-indicated).

Low Risk Pregnancies Post Dates Process: Day 1: Cervical Ripening Balloon Day 2: Propess Day 3: ARM +/- Oxytocin Infusion Day 4: Deliver

Prior to IOL: Maternal observations should be recorded. Normal fetal heart rate pattern should be confirmed by CTG for a period no less than 30 minutes using an NDDH Fresh Eyes Antepartum CTG assessment sticker. Any concerns; escalate to Obstetrician prior to starting IOL.

DAY 1 Insert Balloon Catheter in cervix for 12 hours

Propess in posterior fornix for 24 hours; can be reinserted or replaced if falls out. (Day 2 maximum timeframe)

Able to ARM, liaise with labour ward co-ordinator. ARM at earliest opportunity. (Day 3 maximum timeframe)

Unable to ARM

Monitoring 4 hrly FH & movements- start CTG if any concerns 4 hrly uterine activity, vaginal loss. 4 hrly maternal observations on MEOWS Assess and record any systemic effects

ESCALATE ANY CONCERNS PROMPTLY

Unable to ARM

Commence Oxytocin infusion; After ARM for Primips 2hrs after ARM for multips (Day 3 maximum timeframe)

Full discussion between the Consultant and the woman. Individualised plan with clear timeframe to be documented. N.B Maximum 4 day timeframe from start

IOL to delivery.

DELIVER BABY Day 4

maximum timeframe

Under no circumstances is discharge recommended at any stage during the induction of labour process. Induction of labour is only recommended for clinically indicated rationale and the goal of induction, delivery, must be reached before discharge is recommended.



Pre-existing DM with no other maternal or fetal indications -37+0 to 38+6 wks GDM with no other maternal or fetal indications-40+6 wks Decision for IOL by SAS/Consultant only. Maximum timeframes; Day 1: Cervical Ripening Balloon Day 2: Propess Day 3: ARM +/- Oxytocin Infusion Day 4: Deliver HYPERLINK

IOL at 40 - 41 weeks unless individual risk assessment requires earlier. Decision for IOL by SAS/Consultant only. Maximum timeframes; Day 1: Cervical Ripening Balloon Day 2: Propess Day 3: ARM +/- Oxytocin Infusion Day 4: Deliver HYPERLINK

PROM IOL ≥24 hours unless individual risk assessment requires earlier. Maximum timeframes; Day 1: Propess Day 2: ?ARM forewaters +/- Oxytocin Infusion Day 3: Deliver HYPERLINK

PPROM IOL before 34 weeks only if individual risk assessment requires earlier. Maximum timeframes; Day 1: ?ARM forewaters +/- Oxytocin Infusion Day 2: Deliver HYPERLINK

PET

IOL before 34 weeks only if individual risk assessment requires earlier. Decision for IOL by SAS/Consultant only. Maximum timeframes to be based on individualised risk assessment; Step 1: Cervical Ripening Balloon Step 2: Propess Step 3: ARM +/- Oxytocin Infusion Step 4: Deliver HYPERLINK

SFGA/IUGR

IOL before 34 weeks only if individual risk assessment requires earlier. Decision for IOL by SAS/Consultant only. Maximum timeframes to be based on individualised risk assessment; Step 1: Cervical Ripening Balloon Step 2: Propess Step 3: ARM +/- Oxytocin Infusion Step 4: Deliver HYPERLINK

OC IOL before 34 weeks only if individual risk assessment requires earlier. Decision for IOL by SAS/Consultant only. Maximum timeframes to be based on individualised risk assessment; Step 1: Cervical Ripening Balloon Step 2: Propess Step 3: ARM +/- Oxytocin Infusion Step 4: Deliver HYPERLINK

Intrauterine death IOL to commence with Mifepristone unless individual risk assessment requiresother. Decision for IOL by SAS/Consultant only. Maximum timeframes to be based on individualised risk assessment; Day 1: Propess Day 2: ARM +/- Oxytocin Infusion Day 3: Deliver HYPERLINK

Pregnancy >42 weeks Twice weekly assessment with SAS/Consultant in hospital with CTG and USS with uterine Doppler and AFI. Maximum timeframes to be based on individualised risk assessment; Step 1: Cervical Ripening Balloon Step 2: Propess Step 3: ARM +/- Oxytocin Infusion Step 4: Deliver HYPERLINK



Appendix C

BISHOP SCORE ASSESSMENT

INDUCTION OF LABOUR DECISION

Indication

Gestation now

Gestation at Induction…………………..

Discussion complete Initial PROCESS & TIMELINE

Leaflet given Initial Method Step/Day Timeframe

Consent obtained Initial Balloon Indicate 1/2/3/4 State max hrs in situ

Prescription completed Initial Propess Indicate 1/2/3/4 State max hrs in situ

Induction booked Initial ARM Indicate 1/2/3/4 State max hrs to next step

Documents complete Initial Oxytocin Infusion 1/2/3/4 State max hrs in situ

Induction date………………....……..Latest expected date of delivery…………………..………

PRINT/Sign………………………………………………………………………..Date………………….

SCORE 0 1 2 3

Dilation 0 1 to 2 3 to 4 >4

Length 3 2 1 0

Consistency Firm Medium Soft

Position Posterior Mid Anterior

Station -3 -2 -1 IS or >



Appendix D

Induction of labour using a cervical ripening balloon is undertaken at NDDH using the Cook Medical Cervical ripening balloon catheter (CRB) which is a silicone double

balloon catheter. The maximum balloon inflation is: 80ml/balloon. (Fig.A)It is engineered to naturally and gradually dilate the cervix and facilitate labour induction. Ripening and dilation is accomplished by the balloons’ gentle and constant

pressure at the level of the cervix from both the internal and external os.

Fig.A

Advantages

It safely ripens and dilates the cervix without pharmaceuticals

It eliminates the potential side effects of repeat medications

The silicone balloons adapt to the contour of the cervical canal It is easily placed and quickly removed

Although the Cook catheter is generally very safe, it should not be used

simultaneously with prostaglandins or oxytocin as this may increase the risks of:

Uterine

Prior to insertion

Confirm gestational age, singleton pregnancy, vertex presentation, intact membranes, exclude placenta praevia and any contraindications to vaginal birth

A CTG must be performed for 30 minutes before CRB insertion.



Ensure the woman has emptied her bladder. Confirm maternal pulse, blood pressure, respiration rate and

uterine activity meet accepted criteria for induction. Perform an abdominal palpation to confirm presentation and

vaginal examination to obtain a Bishop’s score (unfavourable cervix and ARM not feasible)

Insertion :

Fig B :

Perform a VE and record the Bishop’s score. Insert 2 fingers into the vagina, then

using the other hand to guide, gently advance the CRB through the cervix until both

balloons have entered the cervical canal. (Fig.B)

Fig C:

Inflate the uterine balloon with 20-40ml of saline through the catheter valve U. Once

the uterine balloon is inflated, pull the device back until the balloon abuts the internal



cervical os. (Fig. C)

Time the placement of the balloon so that it is in place no longer than 12 hours

before active labour is induced.

Fig D

Once it is confirmed that the lower vaginal balloon is now outside the external os,

inflate the vaginal balloon catheter valve V with 20ml saline. (Fig D).

Fig E.

Once the balloons are situated on either side of the cervix, add saline (slowly

in 20ml increments) - a maximum of 80mL per balloon (Fig.E)



You may allow the catheter to hang down loosely or tape it to the side of the

thigh if deemed more comfortable.

Alternatively

The procedure can also be conducted using the speculum method. Place the women in a lithotomy position Insert speculum and visualize the cervix. Clean the cervical os with

sterile water Pass the cervical ripening balloon catheter through the cervix

(using sponge forceps) until both balloons have entered the

cervical canal

Then follow the steps as above.

Propess pessary insertion diagram

Secure the pessary between the fore and middle fingers. With consent, using the same technique as a vaginal examination pass the pessary into the posterior fornix. Rotate it gently so that it lies transverse in the posterior fornix ‘wrapped’ behind the cervix.

Ensure there is sufficient tape at the introitus to remove the pessary if necessary.