Obstetric care
Conditions
Interventions
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
Sponsors
None listed
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Women will be excluded if i. There is an intra uterine fetal demise, ii. Their membranes are ruptured, iii. Her fetus has polyhydramnios, iv. Her fetus has severe fetal anomalies, v. Have any contraindication for induction of labor such as Cephalo-pelvic disproportion, obstructive pelvic mass, major degree placenta previa or morbidly adherent placenta. vi. Known latex allergies (Latex gloves will be worn during certain procedures during the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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] | — |
Countries
Sri Lanka
Contacts
Public ContactDr T M S S B Madugalle
Registrar in Obstetrics and Gynaecology
Outcome results
None listed