FindTrial
Sign In

To compare the efficacy of Misoprostol and Isosorbide Mononitrate combination with Misoprostol alone for initiation of labour.

Intravaginal administration of Misoprostol with Isosorbide Mononitrate versus misoprostol alone for cervical ripening in induction of labor in low-risk term pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076816
Enrollment
150
Registered
2024-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None listed

Interventions

Intervention1: DRUG- ISOSORBIDE MONONITRATE AND MISOPROSTOL: GROUP A - ISOSORBIDE MONONITRATE AND MISOPROSTOL IN CERVICAL RIPENING IN INDUCTION OF LABOUR GROUP B - MISOPROSTOL ALONE Intervention2: Ta

Sponsors

Datta Meghe Institute of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primigravida 2. Singleton pregnancy in cephalic presentation 3. Gestational age >37 weeks 4. Bishop score 5. Intact membranes 6. Reactive non stress test (NST)

Exclusion criteria

Exclusion criteria: 1. Suspected chorioamnionitis 2. Contraindications to IMN (isosorbide mononitrate) (hypotension, hypovolemia, cardiac disease, marked anemia) 3. Placenta previa/ unexplained vaginal bleeding 4. Previous cesarean section /other type of uterine surgery 5. Cephalopelvic disproportion 6. Severe preeclampsia 7. Maternal medical disorders 8. IUGR 9. Fetal distress 10. Polyhydramnios 11. Cervical dilation >2.5 cm

Design outcomes

Primary

MeasureTime frame
1.Change in bishop score after 6 hours of administration drug (isosorbide mononitrate plus misoprostol and misoprostol alone) 2.Mode of delivery 3.Duration of first, second, third stage of labour. 4.Induction delivery interval. Timepoint: 1 year—

Secondary

MeasureTime frame
1. Maternal adverse effects- hyperstimulation of uterus, post-partum hemorrhage, headache, dizziness, nausea and vomiting, hypotension and gastrointestinal symptoms. (Visual analogue scale can be used to determine the severity of headaches in both groups. Severe headache is determined if 7 on this scale.) 2. Neonatal adverse effects evaluated in respect to APGAR score at 1 and 5 mins and rate of NICU admissions. Timepoint: 1 year—

Countries

India

Contacts

Public ContactNeha Sethi

Jawaharlal Nehru Medical College, Wardha, Maharashtra

badnemanju@gmail.com

Outcome results

None listed

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