Comparative effectiveness of and maternal acceptability with using cervical massage vs membrane sweep for cervical ripening in pregnant women from 38th week of gestation at a tertiary care unit: A randomized controlled trial

INTERVENTION: Study setting – Wards 3 and 15, De Soysa Hospital for Women, Sri Lanka. Method of randomization ‐ Research Randomizer available at https://www.randomizer.org/ will be used to generate three sets of random numbers. For the first set of numbers, membrane sweeping will be the allocated method of induction. For the second set of numbers, cervical massage will be the allocated method of induction. The third set will be allocated to the control group. Equal sized cards will be prepared and a random number with its allocated method of induction will be printed on each card. These cards will be kept locked in an opaque container in the ward. After a study participant signs the consent form, the next available sequential number will be extracted from the said container and the method mentioned will be administered as the method of induction of labour. Eligible study participants will be allocated randomly to three study groups. In Group S, membrane sweep will consist of insertion of one finger through the internal OS and performing three circumferential passes separating the chorio‐amnion from the lower uterine segment. In Group M, cervical massage consists of three circumferential passes of around the cervix massaging the cervix with examiner’s index and middle fingers for 15‐30 seconds. In Group C, none of the above methods will be used and theses women will be used as the control group for the study. The membrane sweep or the cervical massage will be performed once at 39th and once at 40th weeks of gestation for primiparous women. The membrane sweep or the cervical massage will be performed once at 40th week of gestation for multiparous women. CONDITION: Obstetric care PRIMARY OUTCOME: Percentages of primigravdae who progress to spontaneous labour as defined by a Modified Bishops’ Score of ?7 or ?2 moderate uterine contractions per 10 minutes by 40+6 weeks of gestation. [Delivery or till 40+6 weeks of gestation]; Percentages of multigravdae who progress to spontaneous labour as defined by a Modified Bishops’ Score of =7 or =2 moderate uterine contractions per 10 minutes by 40+6 weeks of gestation. [Delivery or till 40+6 weeks of gestation]; Percentage of primigravidea and multigravidea that did not go into spontaneous labour and needed formal mechanical or pharmacological induction at 40+6 [Delivery or till 40+6 weeks of gestation]; Mean score of a validated questionnaire assessing maternal acceptability in using membrane sweep or cervical massage for cervical ripening among primigravida and multigravida [Delivery or till 40+6 weeks of gestation]; INCLUSION CRITERIA: Recruited women will, i. Have a gestational age more than 38 completed weeks, ii. Not have a clear indication for elective or emergency caesarian section or early delivery iii. Have reassuring fetal conditions defined as having normal fetal growth parameters, doppler values and a normal cardio‐tocogram. iv. Have a Modified Bishops’ Score greater than or equal to 6 SECONDARY OUTCOME: Number of women who had a closed cervical os that precluded the use of membrane sweep (percentage) [Delivery or till 40+6 weeks of gestation]; Time from membrane sweep or cervical massage to delivery (For each intervention) hours [Delivery or till 40+6 weeks of gestation]; Vaginal delivery rate by 40 weeks and by 40+6 weeks for primigravidea after membrane sweep and after cervical massage. (percentage) [Delivery or till 40+6 weeks of gestation]; Vaginal delivery rate by 40+6 weeks for multigravidea after membrane sweep and after cervical massage (percentage) [Delivery or till 40+6 weeks of gestation]; Emergency caesarian section rates in women who underwent cervical massage and membrane sweep respectively (percentage) [Delivery or till 40+6 weeks of gestation]; Percentage of oxytocin augmentation in women who underwent cervical massage and membrane sweep respectively [Delivery or till 40+6 weeks of gestation]; Percentage of uterine hyperstimulation [Delivery or till 40+6 weeks of gestation]; Percentage of post‐partum hemorrhage [Delivery or till 40+6 weeks of gestation]; Percentage of maternal fever [Delivery or till 40+6 weeks of gestation]; Duration of hospital stay in days [Delivery or till 40+6 weeks of gestation]; Maternal satisfaction score [Delivery or till 40+6 weeks of gestation];