Comparing the use of oral labour inducing agent with vaginal agent

Oral versus Vaginal misoprostol for induction of labour - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/02/004402

Enrollment

788

Registered

2014-02-13

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- Pregnancy

Interventions

Intervention1: Oral misoprostol: Oral misoprostol is now known to be safer than vaginal misoprostol (1) but the correct dose is yet to be identified and hence was a research priority in the WHO Recomm

Eligibility

Inclusion criteria

Inclusion criteria: Pregnancies between 37 to 42 weeks of gestation admitted for labor induction with live, singleton fetus Cephalic presentation Bishop score less than 6 Reassuring fetal heart rate Intact membranes

Exclusion criteria

Exclusion criteria: Non-reassuring fetal heart rate Contraindications to vaginal delivery Previous uterine scar Bishops score more than or equal to 7 Ruptured membranes

Design outcomes

Primary

Measure	Time frame
1. Vaginal delivery not achieved within 24 hours 2. Uterine hyperstimulation with fetal heart rate (FHR) changes 3. Caesarean section Timepoint: 1. Vaginal delivery not achieved within 24 hours 2. Uterine hyperstimulation with fetal heart rate (FHR) changes 3. Caesarean section	—

Secondary

Measure	Time frame
Measures of effectiveness Cervix Unfavourable unchanged after 12 hours Need for oxytocin augmentation Complications Serious neonatal morbidity or perinatal death Serious maternal morbidity or death Apgar score less than seven at five minutes Neonatal intensive care unit admission Maternal nausea vomiting diarrhoea Other maternal side-effects Postpartum haemorrhage more than 500ml of blood loss Measures of satisfaction woman or caregiver not satisfiedTimepoint: Measures of effectiveness Cervix Unfavourable unchanged after 12 hours Need for oxytocin augmentation Complications Serious neonatal morbidity or perinatal death Serious maternal morbidity or death Apgar score less than seven at five minutes Neonatal intensive care unit admission Maternal nausea vomiting diarrhoea Other maternal side-effects Postpartum haemorrhage more than 500ml of blood loss Measures of satisfaction woman or caregiver not satisfied	—

Measure

Time frame

Measures of effectiveness Cervix Unfavourable unchanged after 12 hours Need for oxytocin augmentation Complications Serious neonatal morbidity or perinatal death Serious maternal morbidity or death Apgar score less than seven at five minutes Neonatal intensive care unit admission Maternal nausea vomiting diarrhoea Other maternal side-effects Postpartum haemorrhage more than 500ml of blood loss Measures of satisfaction woman or caregiver not satisfiedTimepoint: Measures of effectiveness Cervix Unfavourable unchanged after 12 hours Need for oxytocin augmentation Complications Serious neonatal morbidity or perinatal death Serious maternal morbidity or death Apgar score less than seven at five minutes Neonatal intensive care unit admission Maternal nausea vomiting diarrhoea Other maternal side-effects Postpartum haemorrhage more than 500ml of blood loss Measures of satisfaction woman or caregiver not satisfied

—

Countries

India

Contacts

Public ContactDrJiji Mathews

Christian Medical College and Hospital

hildagrace@gmail.com04162283387

Outcome results

None listed

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