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Sublingual Misoprostol tablets versus intracervical dinoprostone for cervical ripening

Sublingual misoprostol tablet (PGE1) versus intracervical dinoprostone gel (PGE2) for cervical ripening-A Randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033662
Enrollment
80
Registered
2021-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: 25 mcg of misoprostol tablet: sublingually, and will be advised not to chew the tablet, or eat or drink for next 30minutes. Post medication NST will be done after 2 hours. Misoprostol

Sponsors

RamyaA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Single term pregnancies ( >37 weeks of gestational age) Live fetus â??Cephalic presentation. Reassuring fetal heart rate tracing. Pre-induction Bishopâ??s score of less than 6

Exclusion criteria

Exclusion criteria: Previous uterine scars. Estimated fetal weight on scan greater than 4 Amniotic fluid Index less than 5 cm. Fetal malformations. Any contraindication to vaginal delivery like placenta previa Contracted pelvis, Cephalopelvic disproportion Significant fetal or maternal comorbidities like severe pre- eclampsia or IUGR with doppler changes

Design outcomes

Primary

MeasureTime frame
To compare the time taken for cervical ripening between sublingual misoprostol tablets and intracervical dinoprostone gel.Timepoint: To compare the time taken for cervical ripening between sublingual misoprostol tablets and intracervical dinoprostone gel. At baseline ,1 st group every 4 hours max 6 doses,2 nd group every 6 hours max 4 doses

Secondary

MeasureTime frame
To estimate the cumulative dose required in each group. To evaluate the feto-maternal outcome in both groups. Timepoint: Calculate total dose in 24 hours

Countries

India

Contacts

Public ContactRamyaA

Pondicherry institute of medical sciences

Palolalbahadur@gmail.com9894744050

Outcome results

None listed

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