Effectiveness Of Hyoscine Butylbromide Versus Placebo As An Adjunct To Misoprostol For Cervical Ripening Among Nulliparae In Osogbo:A Randomised Control Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202603552803085

Enrollment

104

Registered

2026-03-19

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Cervical ripening among nulliparous women

Interventions

Hyoscine Butylbromide and Misoprostol

Misoprostol with Placebo

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Nulliparous women Singleton pregnancy Cephalic presentation Gestational age =37 weeks confirmed by early ultrasound or reliable LMP Unfavourable cervix (Bishop score =6) Indicated for induction of labour Age 18–40 years Provided written informed consent

Exclusion criteria

Exclusion criteria: Previous Caesarean Section Previous Myomectomy Previous uterine rupture repair Known hypersensitivity to Misoprostol Known hypersensitivity to hyoscine Multiparous women Non-consenting patient Contra-indications to vaginal delivery

Design outcomes

Primary

Measure	Time frame
Time (in hours) to achieve cervical ripening defined as Bishop score of =6	—

Secondary

Measure	Time frame
Induction-to-delivery interval Need for additional misoprostol doses. Mode of delivery (vaginal vs caesarean section) Maternal adverse effects Neonatal outcomes (Apgar score at 1 and 5 minutes)	—

Countries

Nigeria

Contacts

Public ContactOlusegun Oyelami

Senior registrar Department of Obstetrics and Gynecology UNIOSUN Teaching Hospital Osogbo

oyelamisegun9@gmail.com+2347066177659

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 10, 2026