COMPARISON OF MISOPROSTOL 25 mcg vs. 50 mcg FOR INDUCTION OF LABOUR.

A PROSPECTIVE, DOUBLE-BLIND RANDOMISED CONTROL TRIAL TO COMPARE EFFICACY AND SAFETY OF 25 mcg vs. 50 mcg MISOPROSTOL FOR INDUCTION OF LABOUR

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002300

Enrollment

120

Registered

2011-12-27

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- Induction of Labour

Interventions

Intervention1: Misoprostol 50 mcg: Misoprostol 50 mcg every four hourly intravaginal tablets until progress to active labour (Maximum 4 doses) Control Intervention1: Misoprostol 25 mcg: Drug: Misopros

Eligibility

Inclusion criteria

Inclusion criteria: a. Age 18-35 completed years, with obstetric or medical indications for induction of labour. b. 37 to 42 weeks of gestation. c. Singleton fetus. d. Cephalicpresentation. e. Bishop score less than 6. f. Parity less than 2. g. Four or fewer contraction per hour. h. Reactive non-stress test (NST).

Exclusion criteria

Exclusion criteria: Presence of any below mentioned criteria will exclude the participant from the study. a. Abnormal fetal heart pattern. b. Contraindication to vaginal delivery: Malpresentation, suspected cephalopelvic disproportion, placenta previa, abruption placentae. c. Previous cesarean delivery or uterine surgery. d. Unexplained vaginal bleeding. e. Any contraindication to receiving prostaglandins (e.g. asthma, h/o cardiac disease, glaucoma). f. Previous attempt of labor induction for the present pregnancy. g. Active herpes simplex virus infection. h. Parity greater than 2. i. Nonsteroidalanti-inflammatory drugs (including aspirin) within 4 hours of the study drug treatment. j. Pyrexia100?aF. k. Prior serious adverse event related to prostaglandin administered by any route for any indication.

Design outcomes

Primary

Measure	Time frame
Primary Outcome measure Induction-delivery interval in hours Secondary Outcomes Rate of vaginal delivery within 24 hours of induction Change in Modified Bishopâ??s score at 12 hours and 24 hours Safety of misoprostol Tachysystole Hypertonus Uterine hyperstimulation syndrome Cardiotochographic changes in FHR Other adverse effects Need for oxytocin augmentation Rate of instrumental deliveries including cesarean section deliveries Incidence of post-partum haemorrhage Timepoint: 24 hours	—

Measure

Time frame

Primary Outcome measure Induction-delivery interval in hours Secondary Outcomes Rate of vaginal delivery within 24 hours of induction Change in Modified Bishopâ??s score at 12 hours and 24 hours Safety of misoprostol Tachysystole Hypertonus Uterine hyperstimulation syndrome Cardiotochographic changes in FHR Other adverse effects Need for oxytocin augmentation Rate of instrumental deliveries including cesarean section deliveries Incidence of post-partum haemorrhage Timepoint: 24 hours

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Secondary

Measure	Time frame
Secondary Outcomes Rate of vaginal delivery within 24 hours of induction Change in Modified Bishopâ??s score at 12 hours and 24 hours Safety of misoprostol Tachysystole Hypertonus Uterine hyperstimulation syndrome Cardiotochographic changes in FHR Other adverse effects Need for oxytocin augmentation Rate of instrumental deliveries including cesarean section deliveries Incidence of post-partum haemorrhage Timepoint: 24 hours	—

Measure

Time frame

Secondary Outcomes Rate of vaginal delivery within 24 hours of induction Change in Modified Bishopâ??s score at 12 hours and 24 hours Safety of misoprostol Tachysystole Hypertonus Uterine hyperstimulation syndrome Cardiotochographic changes in FHR Other adverse effects Need for oxytocin augmentation Rate of instrumental deliveries including cesarean section deliveries Incidence of post-partum haemorrhage Timepoint: 24 hours

—

Countries

India

Contacts

Public ContactMona Shah

Government Medical College

dravgokhale@yahoo.com09825936807

Outcome results

None listed

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