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The study comparing two ways of giving misoprostol (under the tongue or in the vagina) to help start labour.

A Ramdomised Controlled Trial Evaluating the Efficacy and Safety of Sublingual Versus Vaginal Misoprostol for Induction of Labour

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202509567116777
Enrollment
80
Registered
2025-09-29
Start date
2025-10-23
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Fertility-female

Interventions

Misoprostol administered sublingually at 25mcg every 6hours.
Misoprostol administered vaginally at 25mcg every 6hours to a maximum of 4 doses.

Sponsors

Terna Tivkaa David
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Term pregnancy. 2. A Bishop’s score of less than or equal to 5. 3. A need to terminate pregnancy due to foetal or maternal indications 4. A singleton pregnancy in cephalic presentation with a reassuring foetal heart. 5. The presence of a clinically satisfactory foetus.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to prostaglandins or their analogues. 2. Previous caesarean section or other uterine surgeries. 3. Chorioamnionitis 4. Foetal distress and the need for immediate delivery. 5. Women with macrosomia 6. Unexplained vaginal bleeding 7. Multifoetal pregnancy 8. Grand multiparity 9. Asthma

Design outcomes

Primary

MeasureTime frame
The primary outcome of the proposed study will be the induction-to-delivery interval.

Secondary

MeasureTime frame
Secondary outcomes will include the rate of vaginal delivery within 24 hours of induction, mode of delivery, maternal outcomes such as postpartum blood loss, tachysystole (one contraction exceeding two minutes duration), hyperstimulation (6 or more contractions in 10 min), and maternal satisfaction using a validated Likert scale, and neonatal outcomes (Apgar scores, NICU admissions).

Countries

Nigeria

Contacts

Public ContactTunde Olatunji Olubunmi

Consultant Gynaecologist HOD

olubunmiolatunji@gmail.com08035863359

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026