Comparison of safety of two drugs (Misoprostol and Dinoprostone) used through vaginal route for labour initiation by their effect on fetus by comparing fetal heart rate tracing.

"Comparison of Fetal Effect of Vaginal Misoprostol Tablet Vs Vaginal Dinoprostone Gel While Using as Labour inducing Agent by Cardiotocographic Tracing - An Open label randomized control safety Trial"

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027493

Enrollment

140

Registered

2020-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Vaginal Misoprostol tablet, 50 mcg.: Vaginal ,Misoprostol tablet, 50 mcg to be given per vaginally at 6 hrs interval maximum 2 such Control Intervention1: Vaginal Dinoprostone gel, 0.5m

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy, cephalic presentation, >36 completed weeks of gestation (confirmed by date and ultrasonography) needs labour induction and having unfavourable cervix and a reassuring CTG (20 minutes tracing) before induction.

Exclusion criteria

Exclusion criteria: 1.Scarred uterus 2.Antepartum haemorrhage 3.Any evidence of fetal compromise as shown by Doppler velocimetry/ biometry 4.Any contraindication for vaginal delivery

Design outcomes

Primary

Measure	Time frame
To compare fetal heart rate abnormalities in Misoprostol and Dinoprostone group by comparing post drug CTG tracing.Timepoint: 1 hour after drug administration.	—

Secondary

Measure	Time frame
Induction to delivery interval.Timepoint: At the time of delivery.;Rate of failed induction and caesarean section.Timepoint: 6 hours after the 2nd dose of drug.	—

Countries

India

Contacts

Public ContactAjanta Samanta

Medical College, Kolkata

drajanta@gmail.com9836567672

Outcome results

None listed

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