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Comparative study of two drugs(Dinoprostone gel and mifepristone)for labour pain stimulation

SAFETY AND EFFICACY OF ORAL MIFEPRISTONE VERSUS INTRACERVICAL DINOPROSTONE GEL AS A CERVICAL RIPENING AGENT AMONG PREGNANT WOMEN REQUIRING LABOUR INDUCTION ââ?¬â?? A RANDOMIZED CONTROL TRIAL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045885
Enrollment
100
Registered
2022-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O630- Prolonged first stage (of labor)

Interventions

Intervention1: Mifepristone: Oral mifepristone tablet 200mg for induction of labour Control Intervention1: Dinoprostone gel: Dinoprostone gel vaginally 0.5mg every 8 hours maximum 3 doses/till inducti

Sponsors

Dr P Srirohini
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Willing to participate 2. Primigravida 3. Singleton pregnancy,Cephalic presentation. 4. Gestational age 40+ weeks. 5. Maternal age >19years 6. No contraindications for prostaglandins or mifepristone. 7. No contraindication for vaginal delivery 8. Modified Bishopââ?¬•s Score 9. Intact membranes. 10.Women with history of 1 or 2 previous abortions.

Exclusion criteria

Exclusion criteria: Breech presentation Cephalopelvic disproportion History of 3 or more abortions Estimated fetal weight > 4.5 kg or Multigravida,Twin pregnancy Obstetric complications like Diabetes ,Abruptio placenta or Placenta previa. Abnormal fetal heart rate patterns. Premature rupture of membranes. Active genital infection. Contraindication for mifepristone Chorioamnionitis Myoma or uterine anomalies IUDââ?¬•S IVF Conception

Design outcomes

Primary

MeasureTime frame
Change in bishop scoreTimepoint: at 8, 16 and 24 hours after administration of the drug—

Secondary

MeasureTime frame
Induction to delivery interval,mode of delivery,,cesarean for failed induction ,any adverse events,maternal and fetal outcomeTimepoint: 24 -48 hours—

Countries

India

Contacts

Public ContactDr Anitha A M

ESIC MC PGIMSR, Chennai

anithaam1982@gmail.com7299027672

Outcome results

None listed

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