R. Vlk, L. Hruban, P. Janků, O. Šimetka, I. Michalec, J. Záhumenský, A. Toman, R. Doubek, K. Roušarová

Dept of Gynecology and Obstetrics, 2nd Medical School, Charles University in Prague, Czech RepublicDept of Gynecology and Obstetrics, Masaryk University, University Hospital Brno, Czech Republic

Dept of Gynecology and Obstetrics, University Hospital Ostrava, Czech RepublicDept of Gynecology and Obstetrics, 3rd Faculty of Medicine and Faculty Hospital in Prague, Czech Republic

Dept of Gynecology and Obstetrics, Regional Hospital in Kolín, Czech RepublicDept of Gynecology and Obstetrics, Regional Hospital in Znojmo, Czech Republic

Effi cacy and safety of the osmoti c dilator Dilapan-S®for cervical ripening in women with/without

Caesarean secti on

Objecti ve:The purpose of this study is to evaluate effi cacy and safety of use of the syntheti c osmoti c dilator Dilapan-S® for cervical ripening prior to labor inducti on according to defi ned criteria and to compare results in females with/without caesarean secti on in their medical history.

Material and methods:The study was designed as an observati onal, prospecti ve, multi centre, data collecti on, performed between 15. May 2013 and 31. October 2013. The 96 females with singleton pregnancy aft er 36 week of gestati on with cephalic presentati on of the baby and Bishop score < 4 were included in the data analysis. 35 pati ents (36.5 %) had a Caesarean secti on reported in their medical history, while the group of females without previous Cae-sarean secti on involved 61 women (63.5 %). Assessment of the primary objecti ve and success of cervical ripening procedure was based on the Bi-shop (cervical) score. Safety data collecti on was focused on fetal hypoxia, uterine hypertonus, clinical signs of infecti on and other potenti al adverse eff ects related to the use of Dilapan-S®. We evaluated answers about sa-ti sfacti on from pati ent’s questi onnaire.

Results 1:The evaluati on of effi cacy of the medical device Dilapan-S® in labor pre-in-ducti on showed that the applicati on was eff ecti ve regarding of the Bishop score progression with the increase from a mean of 2.81 to 6.13, which was confi rmed as stati sti cally signifi cant. Successfull pre-inducti on (Bi-shop score 5 and more) was achieved in 86.5 % of women. In our study 68 females (71.6 %) delivered vaginally, 27 females (28.4 %) delivered by Caesarean secti on. When comparing the subgroup of women with a Caesarean secti on in their medical history and the subgroup of women without previous CS, there was no signifi cant diff erence in the rati o of completed vaginal births.

Tab. 1: Comparison of delivery mode in women with/without Caesarean secti onin previous history

Fig. 1: Dilapan-S® osmoti c cervical dilator before and aft er anisotropic swelling

Graph. 1: Mode of delivery in allwomen (n = 95)

Graph. 2: Mode of delivery in women without SC in previous history (n = 61)

Results 2:In most cases inserted dilators of Dilapan-S were in situ overnight. The ave-rage number of dilators inserted were 3 (range: 2–5). The pati ents questi -onnaire was completed by all 96 mothers. 89 women (93.7 %) evaluated the procedure of inserti on of Dilapan-S® as similar to other gynecological examinati ons or more unpleasant but sti ll quiet tolerable. Pati ent’s so-reness assessment of Dilapan-S® inserti on resulted in a mean pain score of 3.2 (0 –10 points scale). 79 % of all women were able to sleep without any problems or with only minor diffi culti es. Uterine contracti ons during cervical ripening phase were assessed as none, mild or moderate in 90 % of all women.

Results 3:Uterine hypertonus during pre-inducti on was not recorded. Signs of fetal hypoxia did not occur on CTG trace during pre-inducti on. A pH value of 7.10 and less from umbilical artery was found in 1 newborn (1.0 %). Apgar score at 5th minute less than 7 was found in 1 newborn (1.0 %). One case of postpartum metriti s was reported aft er vaginal delivery in the sub-group with CS in previous history. Postpartum infecti ous complicati ons in newborns were not reported. The extracti on of Dilapan-S® was assessed by physician as easy in 100 %. Rupture of membranes associated with in-serti on of Dilapan-S® was not reported in any of the parti cipati ng females.

Conclusion:Dilapan-S® administered for cervical ripening prior to labor inducti on was eff ecti ve concerning the increase of the Bi-shop score in females regardless of Caesarean secti on in the-ir medical history. 71,6 % of all females delivered vaginally. The majority (93,7 %) of all women evaluated the inserti on of Dilapan-S® as fully acceptable. 79 % of all females were able to sleep without any or only minor problems. Use of Dilapan-S® was not associated with occurrence of excessive uterine con-tracti ons, infecti ons or other complicati ons in all 96 cases.

Vaginal

Mode of delivery

Caesareansecti on

68

n

27

71.6 %

%

28.4 %

22

n

12

64.7 %

%

35.3 %

46

n

15

75.4 %

%

24.6 %

All females Females withprevious SC

Females withoutprevious SC

Spontaneous vaginal

70 %

Spontaneous vaginal

72 %

Caesareansecti on

28 %

Caesareansecti on

25 %

VEX 2 %VEX 3 %

93,7 % women evaluated Dilapan-S inserti on as fully acceptable

Dilapan-S® allows 4 from 5 women to sleep during cervical ripening process

Graph. 3: Women sati sfacti on / inserti on assessment

% of women

% of women

Graph. 4: Women sati sfacti on / opportunity to sleep during cervical ripening process

More unpleasant than previousgynecological examinati ons,

but sti ll quite bearable

I could fall asleepand slept duringcervical ripening

Similar to othergynecologicalexaminati ons

I slept well

Veryunpleasant

I fell asleep for a while / I was not able to fall asleep

0

0

20

20

40

40

60

60

80

80

100

100

References: 1. Jozwiak, M. et al.: Mechanical methods for inducti on of labour (Review), The Cochrane Library, 20122. Mozurkewich, L. et al.: Methods of inducti on of labour: a systemati c review, BMC Pregnancy and Childbirth, 2011

3. Gilson, J. et al: A prospecti ve randomised evaluati on of hygroscopiccervical dilator, DILAPAN, in the preinducti on ripening of pati ents undergoing inducti on of labor, AJOG, 1996