Skip to content

Safety And Efficacy Sublingual Misoprostol Versus Vaginal Misoprostol.

Safety And Efficacy Of Sublingual Versus Vaginal Misoprostol For Labour Induction Among Primigravida At Term: A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202310744034060
Enrollment
82
Registered
2023-10-03
Start date
2023-10-01
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

Labour induction outcome

Interventions

sublingual misoprostol arm
Vaginal misoprostol arm as standard treatment arm

Sponsors

Dr. Aituma Lewis Osadebamwen
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Prigravida Gestational age =37 to 42 weeks. Participants who have indication for induction of Labour. Cervical assessment with Modified Bishops score value of less than 6. Singleton gestation. Cephalic presentation. Optimal biophysical profile. Participants who gave written consent to participate in the study.

Exclusion criteria

Exclusion criteria: Teenage pregnancy. Participants who withdraw consent even after being enrolled into the sudy. All indications for Cesarean section. Participants with relative or absolute contraindications to misoprostol use (e.g.; misoprostol allergies, Acute Cerebrovascular Disease, Coronary Artery Disease, epileptics). A history of extensive uterine surgery. Abnormal vaginal bleeding. An unconscious patient.

Design outcomes

Primary

MeasureTime frame
Mean interval from the first dose of misoprostol to onset of adequate uterine contraction in both groups and mean induction of labour - delivery interval.

Secondary

MeasureTime frame
Mean doses of misoprostol required for IOL in both groups. Proportion of women who require oxytocin augmentation in both groups. Proportion of women who achieve vaginal delivery in both groups. Proportion of women who required caesarean delivery in both groups.

Countries

Nigeria

Contacts

Public ContactYemihan Ogbetere

ISTH HREC Administrator and Consultant Public Health Physician

yemihanogbetere@gmail.com+2348030770741

Outcome results

None listed

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