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A clinical trial to study the effect of mifepristone to hasten the process of labour

Role of Mifepristone in cervical ripening for induction of labour in non high risk pregnant women - A Double Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032211
Enrollment
120
Registered
2021-03-23
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: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Mifepristone: Tab. Mifepristone 200 mg OD for 2 day Control Intervention1: Vitamin C: Tab. Vitamin C will be given as placebo.

Sponsors

SHAILY TYAGI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients giving consent for study Singleton pregnancy Gestational age >= 40 completed weeks (Gestation age confirmed by earliest ultrasound and reliable date of last menstrual period) with cephalic presentation Adequate pelvis Bishop score Reactive NST Age >18 â?? 35 year.

Exclusion criteria

Exclusion criteria: Patients not giving consent for the study Multiple pregnancy Any obstetrics contraindication for induction of labour (previous scar on uterus, any coagulation failure, placenta previa) Patients with any other associated medical condition like gestational diabetes mellitus, hypertension, sepsis, pyrexia, disease which contraindicates the use of mifepristone like adrenal insufficiency Estimated fetal weight >= 4kg Parity >4 Oligohydromnios Fetal growth restriction.

Design outcomes

Primary

MeasureTime frame
1.Improvement in bishopâ??s score 2.Duration of induction to active phase of labour 3.Requirement of dinoprostone gel and its mean dose 4.Requirement of oxytocin and its mean dose Timepoint: 4 weeks

Secondary

MeasureTime frame
1.Active phase to delivery interval 2.Mode of delivery 3.Maternal side effects 4.APGAR Score 5.NICU Admissions Timepoint: 4 weeks

Countries

India

Contacts

Public ContactSHAILY TYAGI

BHAGAT PHOOL SINGH GOVERNMENT MEDICAL COLLEGE FOR WOMEN KHANPUR KALAN SONIPAT HARYANA

siwachsunita@ymail.com9812266400

Outcome results

None listed

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