A clinical trial to study the effects of two drugs, Dinoprostone gel and tablet Misoprostol in pregnant women who are planned for induction of labour

Intracervical dinoprostone versus vaginal misoprostol for induction of labour: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024809

Enrollment

Registered

2020-04-23

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: O759- Complication of labor and delivery, unspecified

Interventions

Intervention1: Tablet Misoprostol group: PGE1 (per vaginal Misoprostol tablet 25 mcg 6 hourly maximum 4 doses) with or without oxytocin for IOL (Induction of labour) Control Intervention1: Dinoproston

Eligibility

Inclusion criteria

Inclusion criteria: 1) Modified BISHOP score at recruitment less than or equal to 6 2) Gestational age more than or equal to 37 weeks to 42 weeks 3) Live fetus 4) Singleton pregnancy 5) Cephalic presentation 6) Indication for IOL( IUGR, hypertensive disorders of pregnancy, gestational diabetes mellitus, etcetera)

Exclusion criteria

Exclusion criteria: 1) Preterm IOL 2) Multifetal gestations 3) Non- cephalic presentations 4) Previous uterine scar and rupture 5) Premature rupture of membranes ( PROM) 6) Antepartum heamorrhage 7) Fetal anomalies 8) Active genital herpes 9) Pelvic structural deformities associated with cephalopelvic disproportion 10) Invasive cervical carcinoma 11) Previous pelvic surgeries like trachelorrhaphy, vesicovaginal fistula / rectovaginal fistula/ pelvic floor repair ( third or fourth degree perineal tears repair) 12) Patients wishing for elective CS

Design outcomes

Primary

Measure	Time frame
To compare the induction to delivery interval between PGE2 ( intracervical Dinoprostone gel 0.5 mg 2 doses 6 hours apart) and PGE1( per vaginal Misoprostol tablet 25 mcg 6 hourly maximum 4 doses) with or without oxytocin for IOL( Induction of Labour)Timepoint: 2020-2022	—

Secondary

Measure	Time frame
1. To compare the maternal and fetal outcomes between the two groups 2. To compare the pre-induction of labour transvaginal scan (IOL-TVS) cervical length predictability in the outcome of induction of labourTimepoint: 2020-2022	—

Countries

India

Contacts

Public ContactTheishingla Mashangva

All India Institute of medical Sciences, Bhubaneswar, Bhubaneswar

swetsingh@hotmail.com9438884131

Outcome results

None listed

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