Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial
Brief Summary: A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all pregnancies are prolonged.

A Cochrane review on induction of labour showed that a policy of labour induction at or beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French College of Obstetricians and Gynaecologists stated, "induction of labour can be proposed to patients between 41+0 and 41+6 weeks of gestation". In cases where labour is induced and cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double balloon) methods. Those two methods were compared in the PROBAAT trial among women with term pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical ripening was mechanical.

Considering pharmacological cervical ripening is associated with more uterine hyper stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are associated with a risk of FHR anomalies and that cervical ripening with a pharmacological method is another factor which increases this risk: women with prolonged pregnancies could benefit from a more "gentle" cervical ripening.

At present, no particular method is recommended in cases of cervical ripening and prolonged pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.


Options:
A: Arm Label: Combined approach: Foley Balloon + Vaginal Misoprostol; Type: EXPERIMENTAL; Interventions: Device: Foley Balloon + Vaginal Misoprostol | Arm Label: Single approach: Vaginal Misoprostol only; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vaginal Misoprostol | Intervention Type: DRUG; Name: Vaginal Misoprostol; Assigned to Arm(s): Single approach: Vaginal Misoprostol only | Intervention Type: DEVICE; Name: Foley Balloon + Vaginal Misoprostol; Assigned to Arm(s): Combined approach: Foley Balloon + Vaginal Misoprostol
B: Intervention Type: DRUG; Name: low dose oxytocin; Assigned to Arm(s): N/A
C: Arm Label: Expectant management (EM) arm; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Induction of Labor (IOL) arm; Type: EXPERIMENTAL; Interventions: Procedure: Induction of Labor | Intervention Type: PROCEDURE; Name: Induction of Labor; Assigned to Arm(s): Induction of Labor (IOL) arm
D: Arm Label: Mechanical cervical ripening; Type: EXPERIMENTAL; Interventions: Device: Mechanical cervical ripening | Arm Label: Pharmacological cervical ripening; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pharmacological cervical ripening | Intervention Type: DEVICE; Name: Mechanical cervical ripening; Assigned to Arm(s): Mechanical cervical ripening | Intervention Type: DRUG; Name: Pharmacological cervical ripening; Assigned to Arm(s): Pharmacological cervical ripening

Answer: D