Vaginal Prostaglandin E2 versus oxytocin for induction of labour in women with pre-labour rupture of membranes at term

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2014/008

Enrollment

150

Registered

2014-04-06

Start date

2014-04-15

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Induction of labour

Interventions

Computer generated random numbers will be used to allocate participants into the study and control groups by stratified (primiparous, multiparous) block randomization. Rupture of membranes will be co

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ruptured membranes confirmed by speculum examination 2. Period of amenorrhoea of 37 weeks or more 3. Single fetus in cephalic presentation 4. Unfavorable cervix (Modified Bishops score of 6 or less).

Exclusion criteria

Exclusion criteria: 1. Active labour 2. Previous caesarian section 3. Meconium staining of amniotic fluid 4. Maternal fever

Design outcomes

Primary

Measure	Time frame
1. Caesarean section rate – percentage of caesarean sections out of the total number of inductions for each arm. 2. Post partum maternal fever – Axillary temperature will be measured four times a day. Temperature rise above 100.4 0F (38 0C) maintained over 24 hours during first 72 hours of delivery will be considered as post partum maternal fever 3. SCBU admission – Admission and stay for more than 24 hours in SCBU 4. Neonatal fever – Axillary temperature will be measured four times a day. Temperature rise above 100.4 0F (38 0C) maintained over 24 hours during first 72 hours will be considered as neonatal fever. 5. Induction to delivery interval – duration from protaglandin insertion to delivery of the baby will be considered as induction to delivery interval for study group. Duration from starting oxytocin to delivery of the baby will be considered as induction to the control group. [1.From recruitment to delivery of the baby 2.Four times daily for 72 hours after delivery 3.From delivery of the baby to discharge from hospital 4.Four times daily for 72 hours after delivery 5.From point of induction (prostaglandin insertion ) for study group and from starting oxytocin infusion (for control group) until delivery of the baby. ]	—

Measure

Time frame

1. Caesarean section rate – percentage of caesarean sections out of the total number of inductions for each arm. 2. Post partum maternal fever – Axillary temperature will be measured four times a day. Temperature rise above 100.4 0F (38 0C) maintained over 24 hours during first 72 hours of delivery will be considered as post partum maternal fever 3. SCBU admission – Admission and stay for more than 24 hours in SCBU 4. Neonatal fever – Axillary temperature will be measured four times a day. Temperature rise above 100.4 0F (38 0C) maintained over 24 hours during first 72 hours will be considered as neonatal fever. 5. Induction to delivery interval – duration from protaglandin insertion to delivery of the baby will be considered as induction to delivery interval for study group. Duration from starting oxytocin to delivery of the baby will be considered as induction to the control group. [1.From recruitment to delivery of the baby 2.Four times daily for 72 hours after delivery 3.From delivery of the baby to discharge from hospital 4.Four times daily for 72 hours after delivery 5.From point of induction (prostaglandin insertion ) for study group and from starting oxytocin infusion (for control group) until delivery of the baby. ]

—

Secondary

Measure	Time frame
None [None]	—

Countries

Sri Lanka

Contacts

Public ContactD P L Rasanjana

Registrar (Obstetrics & Gynaecology)

lanka.rasanjana@yahoo.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026