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A comparative analytical study of initiation of labour in a term live pregnancy with oral mifepristone tablet v/s intracervical dinoprostone gel in their safety, efficacy and fetomaternal outcome.

COMPARATIVE ANALYSIS OF SAFETY,EFFICACY & FETO MATERNAL OUTCOME WITH INDUCTION OF LABOUR IN TERM LIVE PREGNANCY WITH ORAL MIFEPRISTONE AND INTRACERVICAL DINOPROSTONE GEL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009325
Enrollment
90
Registered
2017-08-09
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- Pregnant woman at term with indication for induction of labour.

Interventions

Intervention1: Mifepristone (RU486): antiprogesterone agent causes softening and dilatation of pregnant cervix and increase in uterine activity. Control Intervention1: dinoprostone gel: prostaglandin

Sponsors

IPGMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Postmaturity ( >40-41weeks) 2) Premature rupture of membranes. 3) Oligohydramnios. 4) Congenital malformation of the fetus. 5) Various maternal conditions( Such as- chronic hypertension and diabetes etc). 6) Bishopâ??s score

Exclusion criteria

Exclusion criteria: 1) Major Cephalopelvic disproportion. 2) Multifetal pregnancy. 3) Malpresentation. 4) Previously scarred uterus. 6)Woman who does not give informed written consent. 7) Mothers age below 18 years. 8.)Unexplained vaginal bleeding, placenta previa . 9) Medical problemâ??s like impaired renal/hepatic or adrenal function.

Design outcomes

Primary

MeasureTime frame
Vaginal delivery achieved within 48 hoursTimepoint: 48 hours

Secondary

MeasureTime frame
1. Induction to delivery interval. 2. Bishopâ??s score improvement after 24 hours. 3. Requirement for augmentation. 4. Requirement of instrument assisted delivery or caesarean delivery. 5. Incidence of serious neonatal morbidity or perinatal mortality. 6. Incidence of serious maternal morbidity / mortality Timepoint: 48 hours

Countries

India

Contacts

Public ContactDR SN BANNERJEE

IPGMER

drsnbcal@gmail.com9830083861

Outcome results

None listed

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