Randomized double blind placebo controlled study of outpatient misoprostol for term pregnant patientswith no risk factors to prevent routine induction of labour and to prevent post dated pregnancy and its complications

Randomized double blind placebo controlled study of outpatient misoprostol for cervical priming to prevent formal induction of labour - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/08/003883

Enrollment

126

Registered

2013-08-06

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: misoprostol 25micrograms: intravaginal misoprostol 25micrograms singledose versus placebo at the outpatient setting at 39weeks Control Intervention1: placebo: intavaginal misoprosto

Eligibility

Inclusion criteria

Inclusion criteria: SINGLETON PREGNANCY AT 38+4WEEKS TO 39+4WEEKS GESTATION,CEPHALIC PRESENTATION,BISHOP SCORE LESS THAN 4,LACK OF CURRENT INDICATION FOR INDUCTION OF LABOUR

Exclusion criteria

Exclusion criteria: RUPTURE OF MEMBRANES,UNEXPLAINED VAGINAL BLEEDING,PRIOR UTERINE INCISION,GESTATIONAL HYPERTENSION,GESTATIONAL DIABETES ,ESTIMATED FETAL WEIGHT MORE THAN 4500GMS

Design outcomes

Primary

Measure	Time frame
INTERVENTION TO DELIVERY INTERVALTimepoint: DURING DELIVERY	—

Secondary

Measure	Time frame
Gestational age at delivery,spontaneous onset of labour or induction of labour,LSCS for failed induction,meconium aspiration syndrome,APGAR less than 6 at 5minutes,NICU admissions,rupture of membranes,bleeding per vaginmTimepoint: same	—

Countries

India

Contacts

Public ContactDrJIJI E MATHEWS

CMC VELLORE

coronistrial@yahoo.co.in04162286172

Outcome results

None listed

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