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

Comparison of two Dinoprostone regimens (spaced versus conventional) for induction of labour in pregnant women with unfavourable cervix: An open label randomised pilot study - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059470

Enrollment

200

Registered

2023-11-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

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

Interventions

Intervention1: Dinoprostone cervical gel: Induction at 0 hours, 12 hours and 48 hours intervals Control Intervention1: Dinoprostone cervical gel: Induction at 0 hours, 6 hours and 12 hours intervals

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Singleton pregnancy 3. Cephalic presentation > 37 weeks period of gestation 4. Unfavourable cervix (Bishop score 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 11. Gestational hypertension at 37-37+6 weeks 12. Gestational diabetes mellitus on diet at 40-40+6 weeks

Exclusion criteria

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 7. Allergic to PGE2 8. Unwilling to give informed written consent

Design outcomes

Primary

Measure	Time frame
Vaginal delivery rates in both groupsTimepoint: 0 to 120 hours	—

Secondary

Measure	Time frame
1. Caesarean section for failed induction, overall caesarean rate in both the groups. 2. Labour specific outcomes: A. Change in Bishop’s score from baseline to every assessment. B. Number of dinoprostone doses received by patient. C. Dose of oxytocin required for induction or augmentation D. Induction-to-delivery interval. 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 4. Patient satisfaction through Likert scale which will be assessed at the time of discharge Timepoint: 0 to 120 hours	—

Measure

Time frame

1. Caesarean section for failed induction, overall caesarean rate in both the groups. 2. Labour specific outcomes: A. Change in Bishop’s score from baseline to every assessment. B. Number of dinoprostone doses received by patient. C. Dose of oxytocin required for induction or augmentation D. Induction-to-delivery interval. 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 4. Patient satisfaction through Likert scale which will be assessed at the time of discharge Timepoint: 0 to 120 hours

—

Countries

India

Contacts

Public ContactNeena Malhotra

AIIMS, New Delhi

malhotraneena@yahoo.com9891557707

Outcome results

None listed

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