A clinical trail to study the effect of two methods for inducing labour for normal delivery in a pregnant female

COMPARISON OF INTRACERVICAL FOLEY CATHETER WITH DINOPROSTONE GEL COADMINISTRATION VERSUS INTRACERVICAL DINOPROSTONE GEL ALONE FOR INDUCTION OF LABOUR IN AN OPEN LABEL RANDONMISED CONTROLTRIAL - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075454

Enrollment

124

Registered

2024-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

None listed

Interventions

Intervention1: INTRACERVICAL DINOPROSTONE GEL: INTRACERVICAL DINOPROSTONE GEL 0.5MG (TOTAL DOSE -1.5 MG ) WILL BE GIVEN 8 HOURLY FOR 24 HOURS Control Intervention1: INTRACERVICAL DINOPROSTONE GEL WITH

Eligibility

Inclusion criteria

Inclusion criteria: 1. Nulliparous women with Bishop 6 or less on admission. 2. Term pregnancy (37-42 weeks). 3. Singleton fetus with cephalic presentation. 4. Reactive Non stress test at time of admission. 5. Intact bag of membranes

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
- To compare the Induction to Delivery interval (IDI), that is the time from first intervention to time of vaginal delivery among the two groupsTimepoint: 24 HOURS DOSE OF DINOPROSTONE GEL-0.5 MG (TOTAL DOSE -1.5 MG)	—

Secondary

Measure	Time frame
1. Change in Modified Bishop score over 8 hours ,16 hours and 24 hours 2. To compare the time taken to reach from induction to active phase of labour (â?¥5cm cervical dilatation) in women between the two groups. 3. To compare the development of maternal complication including tachysystole, chorioamnionitis and endometritis between the two groups. Timepoint: Change in Modified Bishop score over 8 hours ,16 hours and 24 hours	—

Measure

Time frame

1. Change in Modified Bishop score over 8 hours ,16 hours and 24 hours 2. To compare the time taken to reach from induction to active phase of labour (â?¥5cm cervical dilatation) in women between the two groups. 3. To compare the development of maternal complication including tachysystole, chorioamnionitis and endometritis between the two groups. Timepoint: Change in Modified Bishop score over 8 hours ,16 hours and 24 hours

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Countries

India

Contacts

Public ContactMHALO SHITIRI

AIIMS GORAKHPUR UP

RMHALOSHITIRI@GMAIL.COM8787466708

Outcome results