REPEAT INDUCTION VERSUS EXPECTANT MANAGEMENT AFTER FAILED PRIMARY LABOR INDUCTION AT TERM: A RANDOMISED CLINICAL TRIAL AT KENYATTA NATIONAL HOSPITAL.

Not Applicable

• Conditions: Pregnancy and Childbirth; FAILED PRIMARY LABOR INDUCTION; FAILED PRIMARY LABOR INDUCTIO

• Registration Number: PACTR201805002872322

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

The participants to be included will be mothers for induction of labor with:
1.Singleton, live gestation in cephalic presentation
2.Gestation at or beyond 37 weeks 0 days (37 0/7)
3.Post-term pregnancy
4.Bishop score <6 at failed primary labor induction diagnosis
5.Reactive fetal heart rate pattern
6.Intact membranes
7.Oligohydramnios
8.Hypertensive disorders (preeclampsia without severe features and pregnancy induced hypertension)
9.Diabetes mellitus requiring insulin
10.Maternal cardiac disease: mild cardiac disorders
11.Fetal growth restriction without evidence of fetal compromise on Doppler U/S
12.Elective induction
13.Willing to participate and give a signed informed consent

Exclusion Criteria

The participants to be excluded from primary and repeat IOL will be those who have:
1)Contraindications to induction

Absolute: more than 2 previous uterine scar, previous myomectomy, malposition

Relative: malpresentation, non reactivenonstress test, para>3, severe maternal heart disease, severe maternal hypertension, polyhydramnios

2)Contraindications to vaginal delivery e.g. contracted pelvis, type 4 placenta praevia, umbilical cord prolapse, active genital herpes infection, invasive cervical cancer
3)Multiple gestation
4)Estimated fetal weight >4000 or <2000 grams
5)Hypersensitivity to prostaglandins
6)Severe asthma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Time from induction to active phase of labor: entry into active phase of labor within the designated time. This was chosen as a primary outcome in line with literature review that failed IOL should be defined as the inability to achieve active phase of labor. In this instance, final outcome of pregnancy (mode of delivery) which is associated with confounders is not considered.

Secondary Outcome Measures

Name	Time	Method
1)Time from induction to second stage (induction-delivery interval);2)Time from induction to decision to perform CS;3)Final mode of delivery: vaginal vs caesarean delivery;4)Adverse maternal outcome defined as or including maternal nausea, vomiting, diarrhea, postpartum haemorrhage, uterine hyperstimulation with FHR changes, uterine rupture, instrumental vaginal delivery, intensive care unit admission, chorioamnionitis, duration of hospital stay, maternal death;5)Early neonatal morbidity defined as or including meconium-stained liquor, Apgar score less than seven at five minutes, NICU admission for more than 48 hours, neonatal encephalopathy, perinatal death