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Induction of labour in intrauterine fetal demise after 24 weeks of pregnancy comparing two treatment methods

Induction of Labour in Intrauterine Fetal Demise at More than 24 weeks of gestation: a randomized controlled clinical trial evaluating the comparative outcomes of two therapeutic regimens - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108920
Enrollment
80
Registered
2026-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: O364- Maternal care for intrauterine death

Interventions

Intervention1: Two Dose Mifepristone Regimen: Mifepristone 200 mg orally on day 1 and day 2 followed by misoprostol from day 3 as per FIGO 2023 protocol. Misoprostol dose according to gestational age

Sponsors

IPGMER AND SSKM HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 18 45 years women with unscarred uterus, singleton pregnancy, intrauterine fetal demise at More than 24 weeks of gestation, normally situated placenta, unfavorable cervix Bishop score more than 5 and intact fetal membranes

Exclusion criteria

Exclusion criteria: We will exclude women with prior uterine surgeries, congenital uterine abnormality, previous rupture uterus, uterine fibroids, placenta previa, obvious feto-pelvic disproportion or malpresentation not suitable for vaginal delivery, premature rupture of membranes and suspected chorioamnionitis, undiagnosed vaginal bleeding, moderate anaemia, heart disease or any contraindication to mifepristone or misoprostol like chronic adrenal failure or on immunosuppressant

Design outcomes

Primary

MeasureTime frame
Induction to delivery intervalTimepoint: The primary outcome induction to delivery interval will be measured from initiation of misoprostol and recorded at completion of delivery defined as expulsion of fetus and placenta within 72 hours of induction.

Secondary

MeasureTime frame
Total dose of misoprostol requiredTimepoint: From start of misoprostol till delivery;Success rate of induction of labourTimepoint: Within 72 hours of initiation of misoprostol;Maternal side effectsTimepoint: During induction and till delivery;Maternal complicationsTimepoint: During induction and till discharge

Countries

India

Contacts

Public ContactNIRUPAM KANTI DE

IPGMER AND SSKM HOSPITAL

gynae07@gmail.com6290553205

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026