Comparing the use of oral misoprostol with vaginal misoprostol to facilitate spontaneous labour

Randomized double blind placebo controlled study of Outpatient misoprostol 50 Âµg oral versus 25 Âµg vaginal misoprostol for cervical priming to prevent induction of labour for post-dated pregnancy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017318

Enrollment

588

Registered

2019-01-31

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

None listed

Interventions

Intervention1: Oral Misoprostol: 50 mcg stat dose in Outpatient clinic Control Intervention1: Oral Misoprostol and Vaginal misoprostol: Oral Misoprostol 50 mcg and Vaginal misoprostol 25mcg with respe

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy between 39-40 weeks Cephalic presentation with live fetus Bishop score Lack of current indication for Induction of labour Gestational Diabetes on Medical Nutrition Therapy

Exclusion criteria

Exclusion criteria: Ruptured membranes Unexplained vaginal bleeding Prior uterine incision Gestational Hypertension Gestational Diabetes on Oral Hypoglycemic Agents & Insulin Estimated fetal weight >= 4000gm Bad obstetric history Pregnancy by Assisted reproductive technology Malpresentations Multiple gestation Uterine anomaly Bishop score >= 6 Poor dates

Design outcomes

Primary

Measure	Time frame
Need for formal Induction of labour for post-dated pregnancyTimepoint: from 1 hour to 41 weeks	—

Secondary

Measure	Time frame
Patient coming with False labour, PROM, spotting/show, chorioamnionitis, Gestational Age at delivery, Meconium Aspiration syndrome, NICU admission, Intervention to delivery interval, Mode of delivery, Apgar 7 at 5 minutes.Timepoint: from 1 hour to Delivery	—

Countries

India

Contacts

Public ContactSwati Rathore

Christian Medical College

swatixrathore@gmail.com9080566712

Outcome results