Active versus Expectant Management of Pre-labour Rupture of Membranes at term in Enugu, Nigeria. A Randomised Controlled Trial

Effect of Expectant and Active Management with vaginal Misoprostol on the Maternal and Perinatal outcome among Women with Term PROM in Enugu, Nigeria. A Randomised Controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202509717423392

Enrollment

206

Registered

2025-09-30

Start date

2025-01-06

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases Pregnancy and Childbirth Puerperal sepsis and pyrexia, post-partum endometritis, intra-uterine adhesion

Interventions

Misoprostol

oxytocin infusion

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. PROM at term confirmed by clinical and laboratory tests 2. Women with singleton fetus in cephalic presentation 3. PROM < 12 hours duration at the time of presentation 4. Women not in active labor (cervical dilatation <4cm) 5. Women with adequate pelvis 6. No evidence of maternal sepsis (maternal tachycardia, maternal pyrexia, uterine tenderness, and vaginal discharge)

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. PROM at term with ante-partum haemorrhage 2. Evidence of fetal distress or heart rate abnormality 3. Women who had multiple vaginal examinations prior to presentation 4. Chronic medical conditions in pregnancy such as hypertensive disorders of pregnancy and diabetes mellitus 5. Fetal mal-presentation, abnormal lie, multiple pregnancies 6. Women with previous scar 7. Women with cervical cerclage for cervical incompetence Patients who are HIV positive or immune compromised.

Design outcomes

Primary

Measure	Time frame
Mean PROM-to-Delivery interval refers to time intervals from rupture of fetal membranes till delivery. ; Mode of delivery- whether vaginal delivery or instrumental vaginal delivery or caesarean section	—

Secondary

Measure	Time frame
To determine the mean admission-to-delivery interval- refers to time interval from admission in the hospital till delivery;To determine labour and delivery complications such as fetal distress, failed induction, caesarean section and post-partum hemorrhage.; 3. To determine fetal and neonatal outcomes such as first and fifth minutes APGAR scores, neonatal sepsis, neonatal jaundice and NICU admission;To determine maternal satisfaction	—

Measure

Time frame

To determine the mean admission-to-delivery interval- refers to time interval from admission in the hospital till delivery;To determine labour and delivery complications such as fetal distress, failed induction, caesarean section and post-partum hemorrhage.; 3. To determine fetal and neonatal outcomes such as first and fifth minutes APGAR scores, neonatal sepsis, neonatal jaundice and NICU admission;To determine maternal satisfaction

—

Countries

Nigeria

Contacts

Public ContactIjeoma Ezeome

Head of Department Obstetrics and Gynaecology University of Nigeria Teaching Hospital Enugu

ijeoma.ezeome@unn.edu.ng2347058124721

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026