Is oral tablet misoprostol more effective and safer than injectible drug oxytocin in pregnant women at term whose membranes ruptured before the onset of labour pains.

A randomized controlled unmasked trial comparing safety and efficacy of oral misoprostol with intravenous oxytocin for induction in prelabour rupture of membranes at term

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/02/006637

Enrollment

200

Registered

2016-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Pregnant women at term with prelabour rupture of membranes

Interventions

Intervention1: Oral misoprostol: Intravenous oxytocin induction Control Intervention1: oral misoprostol with intravenous oxytocin: Comparing safety and efficacy of 50mcg of oral misoprostol with intra

Eligibility

Inclusion criteria

Inclusion criteria: • Pregnancies between 37 â?? 41 weeks of gestation with singleton foetus with vertex presentation • Reassuring fetal heart rate • Definite diagnosis of PROM

Exclusion criteria

Exclusion criteria: -Contraindications to vaginal delivery -Previous uterine scar -Diagnosis of labour -Meconium stained liquor -Clinical estimated fetal weight > 4 kgs -Evidence of chorioamnionitis, temperature > 100.4 degree Fahrenheit, uterine tenderness or foul smelling amniotic fluid. -Any severe medical disease like diabetes on insulin or severe pre-eclampsia

Design outcomes

Primary

Measure	Time frame
-Duration between induction and delivery -Vaginal delivery achieved within 24 hours -Caesarean section Timepoint: Difference of 2 hours from induction to delivery. 5% difference in LSCS rates	—

Secondary

Measure	Time frame
-Need for oxytocin augmentation -Serious neonatal morbidity or perinatal death eg sepsis,seizures,birth asphyxia,neonatal encephalopathy-Serious maternal morbidity or death eg sepsis,admission to ICU,septicaemia,traumatic PPH-Fever, chorioamnionitis, endometritis-Apgar score less than seven at five minutes-Neonatal intensive care unit admission-Maternal nausea-Maternal diarrhea-Other maternal side-effects-PPH more than500ml of blood loss -Woman and Caregiver not satisfiedTimepoint: Soon after delivery.	—

Measure

Time frame

-Need for oxytocin augmentation -Serious neonatal morbidity or perinatal death eg sepsis,seizures,birth asphyxia,neonatal encephalopathy-Serious maternal morbidity or death eg sepsis,admission to ICU,septicaemia,traumatic PPH-Fever, chorioamnionitis, endometritis-Apgar score less than seven at five minutes-Neonatal intensive care unit admission-Maternal nausea-Maternal diarrhea-Other maternal side-effects-PPH more than500ml of blood loss -Woman and Caregiver not satisfiedTimepoint: Soon after delivery.

—

Countries

India

Contacts

Public ContactDrJiji Mathews

Christian Medical College and Hospital

coronistrial@yahoo.co.in04162283387

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026