A clinical trial to compare conventional versus spaced regimen of dinoprostone gel for induction of labour in pregnant women with unfavourable cervix

Phase 3

• Conditions: Health Condition 1: O80- Encounter for full-term uncomplicated delivery

• Registration Number: CTRI/2023/11/059470
• Lead Sponsor: AIIMS NEW DELHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age > 18 years

2. Singleton pregnancy

3. Cephalic presentation > 37 weeks period of gestation

4. Unfavourable cervix (Bishop score < 7) and no signs of labour

5. Assuring maternal and fetal status

6. Booked at antenatal clinic of department of obstetrics and gynaecology, AIIMS, New Delhi

7. Term induction (40-40+6 weeks by 1st trimester ultrasound)

8. Small for gestational age foetus at 39-39+6 weeks

9. Stage 1 fetal growth restriction at 37-38 weeks

10. Mild intrahepatic cholesatsis of pregnancy with serum bile acids <40 mol/L at 39-40 weeks

11. Gestational hypertension at 37-37+6 weeks

12. Gestational diabetes mellitus on diet at 40-40+6 weeks

Exclusion Criteria

1. Any contraindication to vaginal delivery

2. Bishop score of 7 or more

3. Previous caesarean/uterine scar

4. Rupture of membranes

5. Multiple pregnancy

6. Oligohydramnios (AFI <5)

7. Allergic to PGE2

8. Unwilling to give informed written consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal delivery rates in both groupsTimepoint: 0 to 120 hours

Secondary Outcome Measures

Name	Time	Method
1. Caesarean section for failed induction, overall caesarean rate in both the groups. <br/ ><br>2. Labour specific outcomes: <br/ ><br>A. Change in Bishop’s score from baseline to every assessment. <br/ ><br>B. Number of dinoprostone doses received by patient. <br/ ><br>C. Dose of oxytocin required for induction or augmentation <br/ ><br>D. Induction-to-delivery interval. <br/ ><br>3. Composite obstetric & perinatal outcomes which will be assessed by the duration of hospital stay for the mother & NICU admission for the baby, birth weight & Apgar scores at birth, 1 minute & 5 minutes <br/ ><br>4. Patient satisfaction through Likert scale which will be assessed at the time of discharge <br/ ><br>Timepoint: 0 to 120 hours