Intravaginal isosorbide dinitrate or misoprostol for cervical ripening prior to induction of labour: A randomised controlled trial

Abstract BackgroundThe aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the out-patient setting.MethodsAn open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥16 years, undergoing Induction of labour (IoL) at term, with intact membranes and deemed suitable for out-patient IoL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal Dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Health economics data were collected. Women who declined to participate were also requested to complete a decliners’ questionnaire.ResultsDuring the study period 274 eligible women were identified. 230 (83.9%) were approached for participation of whom 84 (36.5%) agreed. Of these, 38 were randomised to Propess (n=20) and CRB (n=18). The intended sample size of 120 was not reached due to restrictive criteria for suitability for out-patient IoL. The intervention as randomised was received by 29/38 (76%) women. Five of the 29 participants could not go home after intervention. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the Dinoprostone group, and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition (5-minute Apgar score >7) and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded.Full health economics data were available for 36 out of the 38 participants. 21% of women in the Dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group. The patient questionnaire was complete and available for analysis for 37/38 (97.4%) women. Interviews were undertaken for 21/38 women.ConclusionsA third of the approached eligible women agreed for randomisation. An RCT is not feasible using existing criteria and further modifications to the eligibility criteria for out-patient IoL would be needed to reach sufficient numbers in the current service context.

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Mechanical cervicAl ripeninG for women with PrOlongedPregnancies (MAGPOP): protocol for a randomised controlled trial of a silicone double balloon catheter versus the Propess system for the slow release of dinoprostone for cervical ripening of prolonged pregnancies

BMJ Open ◽

10.1136/bmjopen-2017-016069 ◽

2017 ◽

Vol 7 (9) ◽

pp. e016069 ◽

Cited By ~ 2

Author(s):

Caroline Diguisto ◽

Amélie Le Gouge ◽

Bruno Giraudeau ◽

Franck Perrotin

Keyword(s):

Randomised Controlled Trial ◽

Vaginal Delivery ◽

Slow Release ◽

Controlled Trial ◽

Balloon Catheter ◽

Induction Of Labour ◽

Cervical Ripening ◽

Pharmacological Intervention ◽

Open Label ◽

Randomised Controlled

IntroductionInduction of labour for prolonged pregnancies (PP) when the cervix is unfavourable is a challenging situation. Cervical ripening by pharmacological or mechanical techniques before oxytocin administration is used to increase the likelihood of vaginal delivery. Both techniques are equally effective in achieving vaginal delivery but excessive uterine activity, which induces fetal heart rate (FHR) anomalies, is more frequent after the pharmacological intervention. We hypothesised that mechanical cervical ripening could reduce the caesarean rate for non-reassuring FHR especially in PP where fetuses are already susceptible to this.Methods and analysisA multicentre, superiority, open-label, parallel-group, randomised controlled trial that aims to compare cervical ripening with a mechanical device (Cervical Ripening Balloon, Cook-Medical Europe, Ireland) inserted in standardised manner for 24 hours to pharmacological cervical ripening (Propess system for slow release system of 10 mg of dinoprostone, Ferring SAS, France) before oxytocin administration. Women (n=1220) will be randomised in a 1:1 ratio in 15 French units. Participants will be women with a singleton pregnancy, a vertex presentation, a term ≥41+0 and≤42+0 week’s gestation, and for whom induction of labour is planned. Women with a Bishop score ≥6, a prior caesarean delivery, premature rupture of membranes or with any contraindication for vaginal delivery will be excluded. The primary endpoint is the caesarean rate for non-reassuring FHR. Secondary outcomes are related to delivery and perinatal morbidity. As study investigators and patients cannot be masked to treatment assignment, to compensate for the absence of blinding, an independent endpoint adjudication committee, blinded to group allocation, will determine whether the caesarean for non-reassuring FHR was justified.Ethics and disseminationWritten informed consent will be obtained from all participants. The Tours Research ethics committee has approved this study (2016-R23, 29 November 2016). Study findings will be submitted for publication and presented at relevant conferences.Trial registration numberNCT02907060; pre-results.

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