International Document. Approved labeling, indications and instructions may vary by country.

Reference the Instructions for Use labeling for a complete listing of indications, warnings and precautions.

Recommendation for use:

4 mm x 55 mm

4 mm x 65 mm

3 mm x 55 mm

Type Indication

Cervical ripening prior to the induction of labour

Cervical preparation prior to the termination of pregnancy

When Dilapan–S® 4 mm can not be inserted in earlypregnancy, or when removal is to be accomplishedin less then 4 hours

Indications for use:

• cervical ripening prior to the induction of labour• cervical dilation prior to instrumentation of the uterine cavity, eg. termination of pregnancy, ERPC, fetal demise, etc.

Contra-Indications:

• clinically evident genital infection• menstruation

Dilapan–S® is an osmotic hygroscopic dilator produced from a patented Aquacryl hydrogel that guarantees consistency of action. It is a rigid gel rod that increases in volume by absorbing fl uids so gradually dilating the cervix. After 2–6 hours, the 3 mm rod will have expanded to 8.3–10 mm and the 4 mm rod up to 10–12,5 mm.Simultaneously, Dilapan–S® initiates endogenous prostaglandin release causing collagen degradation which softens the cervix.

Dilapan–S® is sterilized by irradiation. It is manufactured in an ISO 9001 Certifi ed facility and is fully CE Certifi ed under the Medical Device Directive (EN46002). Approved by FDA for sale in the United States.

Dilapan–S®

Tips for insertion:

• Moisten Dilapan–S® with sterile water or saline to lubricate the surface prior to insertion.

• A tenaculum may be used to stabilise the cervix and to straighten the cervical canal.

• Grasp Dilapan–S® at the handle. Gradually and without undue force, insert Dilapan–S® until it traverses the external and internal os.

• Do not insert Dilapan–S® past the handle. The border of the handle should rest at the external os.

• If inserting multiple Dilapan–S®, repeat the above steps for each one.

Gentle. Predictable.

Magnitude of cervical dilation depends on the duration of Dilapan–S® insertion

Dilapan–S®, active part dimension 4 mm

Dilapan–S®, active part dimension 3 mm

6 24 h420

mm 1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

10,0

11,2

12,5

14,6

8,3

9,510,0

11,3

• Do not leave Dilapan–S® in place more than 24 hours.

• To remove Dilapan–S®, grasp the handle only with forceps and apply steady downward traction, in line with the long axis of the dilator. Do not twist excessively and do not use the marker string.

• For detailed instructions for use, please read the leafl et in each pack.

Fast acting synthetic osmotic cervical dilator

Dilapan–S®

“Successful labour induction is clearly related to the state of the cervix. Women with an unfavorable cervix who have not experienced cervical ripening phase before labor present the greatest challenge with regard to labor induction”�3

“Labour should only be induced if the Bishop Score is 5 or higher — this indicates sufficient cervical ripening”�2

Hygroscopic dilators (like Dilapan–S®) signifi cantly enhance cervicalripening and increase the Bishop Score enabling smootherlabour induction�4,�5

Dilator group (N =�112)

Dilator group (N =�214)

Control group (N =�128)

PGE2 group (N =�202)

Bishop score after 12 h

Post-ripening cervical score

Initial Bishop score

Admission cervical score

p = 0,001

Non-signifi cant diff erence

Gentle and predictable cervical ripeningprior to the labour induction

Comparison with control group�4

Comparison with PGE�2�5

5,0

6,2

3,0

4,1

Dilapan–S®

3,0 3,0

0

0

1

1

2

2

3

3

4

4

5

5

6

6

7

7

7

7

6

6

5

5

4

4

3

3

2

2

1

1

0

0

6,54,2

Dilator group (N =�214)

Dilapan (N =�90)

PGE2 group (N =�202)

PGE2 gel (N =�95)

Uterine contraction during ripening phase�5

Uterine hyperstimulation and abnormal fetal heart rate changes�10

% of patients

Deceleration of fetal heart rate (%)Uterine hyperstimulation (%)

p = 0,001

Gentle and predictable cervical ripeningprior to the labour induction

47,1

3,15

0 1 2 3 4 5 6 0 1 2 3 4

5,26

Dilapan–S® key benefi ts:

• signifi cant increase in cervical ripening and Bishop score�4,�5

• high predictability due to material and mode of action• minimal risk of uterine hyperstimulation and impact on the fetal heart rate�5,�6

• no pharmacological side eff ects• eff ective and safe even in women with Caesarean section in medical history�12

• accentuates the physiological processes of labour• very high patient acceptability

24,9

0 % 0 %

“Onset of regular uterine activity as a result of preinductionis negative and unwanted side eff ect”�1

“The principal role of the agents used for cervical ripeningis to soften an unripe cervix independent of uterine activity”�3

Gentle. Predictable.

Dilapan–S®

Hygroscopic dilators produce minimal uterine activity duringthe ripening process�5,�7

Dilapan–S®

Society for Family Planning Clinical Guidelines, 2013�8

Conclusions and Recommendations:

Level A:

• When osmotic dilator placement and D&E are to be performed on the same day, Dilapan–S® is preferred over laminaria tents to achieve adequate priming more quickly.• Osmotic dilators achieve more preoperative dilation than mifepristone or misoprostol.• Dilapan–S® is safe and eff ective for cervical preparation prior to D&E.• Use of osmotic dilators does not increase infectious morbidity.

Level B:

• Prior to 20 weeks’ gestation, adequate cervical preparation may be achieved with a single set of osmotic dilators.• Dilapan–S® placed 3–4 h prior to D&E is a safe alternative to overnight dilator placement up to 18 weeks’ gestation.

• Use of misoprostol or mifepristone as an alternative to osmotic tents increases risk of inadequate cervical dilation.• Routine use of adjunctive buccal misoprostol in addition to osmotic dilators is not recommended before 16 weeks’ gestation but may be considered when diffi cult cervical dilation is anticipated or at later gestational ages.

Level C:

• Only experienced providers capable of managing diffi cult cervical dila- tion should use protocols omitting osmotic tent placement prior to D&E.• Overnight placement of osmotic dilators is recommended after 18 weeks’ gestation. Highly expe- rienced D&E providers may consider same-day procedures at later gestations utilizing a combination of osmotic and pharmacologic agents or serial doses of misoprostol.

RCOG Evidence-based Clinical Guidelines, No 7, Nov 2011:�7

• After 14 weeks of gestation, osmotic dilators provide superior dilatation to medical methods (grade B)

RCOG — Royal College of Obstetricians and Gynaecologists D�&�E — dilation and evacuation

Dilapan–S® represents one of the most preferred methods for cervicalpreparation prior D&E procedure in second trimester thanks to itspredictability, efficacy and safety�8

Gentle and predictable cervical preparationprior to the termination of pregnancy

Gentle. Predictable.

Developed to enable same-day D&E procedure in late firstand second trimester�8,�11

Dilapan–S® group (N =�60)

Misoprostol group (N =�62)

Treatment with Dilapan–S® demonstrated statistically improved dilation over misoprostol, when analysis wascontrolled for the inequity of cesarean deliveries between the two arms (P�=�0.049), and when the fi veparticipants misclassifi ed according to strata were removed in a per-protocol analysis (P�=�0.047) respectively.11

Cervical dilation over the course of the 3–4 hours period�11

The ease of further mechanical dilation (% of patients)�11

diameter in mm

Dilapan–S® key benefi ts:

• in comparison with misoprostol, Dilapan–S® off ers higher effi cacy and better predictability helping to avoid challenging situations�8,�11

• effi cacy enables same-day D&E procedure in late 1�st and 2�nd trimester�8,�11

• gradual atraumatic dilation

• signifi cantly reduces the risk of cervical injury and suture repair�8

• preserves full functionality of the cervix for future pregnancy

• no pharmacological side eff ects• minimising risk of uncontrolled abortions, eg. during the night• evaluated by SFP Guidelines as the best product in its class of osmotic cervical dilators�8

10,2

10,8

Dilapan–S®

Fast acting synthetic osmotic cervical dilator

9 10 11

Dilapan–S®

Misoprostol19,0

50,0

52,0

40,0

2010 30 40 50 7060 80 90 1000

10,0

29,0

Not needed / very easy

Moderate

Very diffi cult

Gentle and predictable cervical ripening prior to the labour induction

• signifi cant increase in cervical ripening�4,�5

• high predictability due to material and mode of action• minimal risk of uterine hyperstimulation and impact on the fetal heart rate�5,�6

• no pharmacological side eff ects• eff ective and safe even in women with C.�section* in medical history�12

• accentuates the physiological processes• very high patient acceptability *�C.�section = Caesarean section

Sources:�1. Roztočil A. et al.: Controversies and mistakesin labour induction. Modern Gynecologyand Obstetrics 16/2007, p. 38–46 (in Czech)2. Roztocil A: Preinduction and induction ofLabour, Clinical Guidelines, Update 2010 (in Czech)3. Ramos, L. S. et al.: Induction of Labor, Obstetricsand Gynecology Clinics of North America, 32(2005), p. 181–200 4. Gilson, J. et al: A prospectiverandomised evaluation of hygroscopic cervicaldilator, DILAPAN, in the preinduction ripening ofpatients undergoing induction of labor, AmericanJournal of Obstetrics and Gynecology, July 1996,Vol. 175, No 1 5. Krammer, J. et al.: Pre-induction cervicalripening: A randomised comparison of two methods,Obstetrics and Gynecology, Vol 85, No 4, April 1995, p. 614–6186. Jozwiak, M. et al.: Mechanical methods for induction of labor(review), Cochrane review, The Cochrane Library 2012, Issue 37. Royal Colleqe of Obstetricians and Gynaecologists: The Care of Women Requesting Induced Abortion: Summary. Evidence-based Clinical Guideline, No 7, November 2011 8. Society of FamilyPlanning: Clinical Guidelines — Cervical preparation for second-trimester surgical abortion prior to 20 weeks’ gestation, Contracep-tion, 2013 9. Society of Family Planning: Clinical Guidelines: Guide-lines — Cervical preparation for surgical abortion from 20 to 24 weeks gestation, Contraception 77, 2008 10. Chua, S. et al.: Preinduction Cervical Ripening: Prostaglandine E2 Gel vs Hygroscopic Mechanical Dilator, J. Obstet. Gynaecol. Res., Vol 23, No 2, 1997, 171–177 11. Bartz, D. et al.: Buccal misoprostole compared with synthetic osmoticcervical dilator before surgical abortion. A rando-mised controlled trial. Obstetrics & Gynecology, Vol 122, No 1, July 2013, p. 57–6312. Hruban, L. et al: What is the position of mechanical pre-induction cervical ripening in modern obstetrics, Poster presentation, RCOG World Congress, Liverpool, UK, 24–26 June 2013

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