e cacy and safety of the osmo c dilator dilapan-s for...

Poster presented at 13rd World Congress in Fetal Medicine, June 29 th – July 3rd, 2014, Nice, France

R. Vlk, L. Hruban, P. Jank , 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

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

Caesarean sec on

Objec ve:The purpose of this study is to evaluate e cacy and safety of use of the synthe c osmo c dilator Dilapan-S® for cervical ripening prior to labor induc on according to de ned criteria and to compare results in females with/without caesarean sec on in their medical history.

Material and methods:The study was designed as an observa onal, prospec ve, mul centre, data collec on, performed between 15. May 2013 and 31. October 2013. The 96 females with singleton pregnancy a er 36 week of gesta on with cephalic presenta on of the baby and Bishop score < 4 were included in the data analysis. 35 pa ents (36.5 %) had a Caesarean sec on reported in their medical history, while the group of females without previous Cae-sarean sec on involved 61 women (63.5 %). Assessment of the primary objec ve and success of cervical ripening procedure was based on the Bi-shop (cervical) score. Safety data collec on was focused on fetal hypoxia, uterine hypertonus, clinical signs of infec on and other poten al adverse e ects related to the use of Dilapan-S®. We evaluated answers about sa- sfac on from pa ent’s ques onnaire.

Results 1:The evalua on of e cacy of the medical device Dilapan-S® in labor pre-in-duc on showed that the applica on was e ec ve regarding of the Bishop score progression with the increase from a mean of 2.81 to 6.13, which was con rmed as sta s cally signi cant. Successfull pre-induc 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 sec on. When comparing the subgroup of women with a Caesarean sec on in their medical history and the subgroup of women without previous CS, there was no signi cant di erence in the ra o of completed vaginal births.

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

Fig. 1: Dilapan-S® osmo c cervical dilator before and a 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 pa ents ques -onnaire was completed by all 96 mothers. 89 women (93.7 %) evaluated the procedure of inser on of Dilapan-S® as similar to other gynecological examina ons or more unpleasant but s ll quiet tolerable. Pa ent’s so-reness assessment of Dilapan-S® inser 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 di cul es. Uterine contrac ons during cervical ripening phase were assessed as none, mild or moderate in 90 % of all women.

Results 3:Uterine hypertonus during pre-induc on was not recorded. Signs of fetal hypoxia did not occur on CTG trace during pre-induc 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 metri s was reported a er vaginal delivery in the sub-group with CS in previous history. Postpartum infec ous complica ons in newborns were not reported. The extrac on of Dilapan-S® was assessed by physician as easy in 100 %. Rupture of membranes associated with in-ser on of Dilapan-S® was not reported in any of the par cipa ng females.

Conclusion:Dilapan-S® administered for cervical ripening prior to labor induc on was e ec ve concerning the increase of the Bi-shop score in females regardless of Caesarean sec on in the-ir medical history. 71,6 % of all females delivered vaginally. The majority (93,7 %) of all women evaluated the inser 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-trac ons, infec ons or other complica ons in all 96 cases.

Vaginal

Mode of delivery

Caesareansec 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 %

Caesareansec on

28 %

Caesareansec on

25 %

VEX 2 %VEX 3 %

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

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

Graph. 3: Women sa sfac on / inser on assessment

% of women

% of women

Graph. 4: Women sa sfac on / opportunity to sleep during cervical ripening process

More unpleasant than previousgynecological examina ons,

but s ll quite bearable

I could fall asleepand slept duringcervical ripening

Similar to othergynecologicalexamina 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 induc on of labour (Review), The Cochrane Library, 20122. Mozurkewich, L. et al.: Methods of induc on of labour: a systema c review, BMC Pregnancy and Childbirth, 2011

3. Gilson, J. et al: A prospec ve randomised evalua on of hygroscopiccervical dilator, DILAPAN, in the preinduc on ripening of pa ents undergoing induc on of labor, AJOG, 1996