A study comparing two methods of inducing labour in women with term pregnancy

Comparative study of safety and efficacy of dinoprostone vaginal insert versus dinoprostone gel for cervical ripening and induction of labour - DINO-IOL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109072

Enrollment

Registered

2026-04-22

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: O099- Supervision of high risk pregnancy, unspecified

Interventions

Intervention1: Dinoprostone vaginal insert: 10mg controlled release for a total duration of 6months Control Intervention1: Dinoprostone vaginal gel: 0.5mg intracervical gel for total duration of 6 mon

Eligibility

Inclusion criteria

Inclusion criteria: In this study we will include pregnant women with Term singleton pregnancy with indications for Induction of labour like gestation Hypertension,gestational diabetes and Oligohydrominos having bishop score less than 6

Exclusion criteria

Exclusion criteria: It include pregnant women in active phase of labour with ruptured membranes or having previous history of c section or myomectomy or allergic to prostaglandins

Design outcomes

Primary

Measure	Time frame
Induction to delivery intervalTimepoint: start point:time when dinoprostone is administered either gel or vaginal End point: time when baby is delivered(vaginal or C section)	—

Secondary

Measure	Time frame
Change in bishop scoreTimepoint: Baseline(before drug) at 0.0 mins & every 6 hours until active labour that is 6hrs, 12hrs etc;Need for oxytocin augmentationTimepoint: During labour until delivery that is 0,2,4,6hrs;Maternal complicationsTimepoint: During labour and within 24 hours postpartum;Neonatal outcomesTimepoint: Apgar at Birth, 5 min & until discharge from nursery	—

Countries

India

Contacts

Public ContactShweta Gupta

DR SN MEDICAL COLLEGE,JODHPUR

hod.obstgyne@gmail.com9468813459

Outcome results

None listed

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