Effectiveness of Intramuscular Hyoscine Butylbromide in Reducing the First Stage of Labour Among Nulliparous Women at Term: A Randomised Double-Blind, Placebo-Controlled Trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202601774213602

Enrollment

150

Registered

2026-01-12

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Labour

Interventions

Water for Injection

Hyoscine Butylbromide

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Consenting nulliparous women at term (37–42weeks) 2. Singleton fetus in cephalic presentation 3. Spontaneous labour onset with cervical dilatation =5cm. 4. Intact membranes or spontaneous rupture <12 hours. 5. No prior use of uterotonic or antispasmodic medications.

Exclusion criteria

Exclusion criteria: 1. Contraindications to vaginal delivery 2. Multiple gestation 3. Medical disorders in pregnancy 4. Antepartum haemorrhage 5. Foetal distress or congenital anomalies 6. History of uterine or cervical surgery 7. Known allergy to Hyoscine Butylbromide

Design outcomes

Primary

Measure	Time frame
Difference in the mean duration of the active phase of labour between the intervention group (HBB) and the control group.	—

Secondary

Measure	Time frame
- Proportion of women who progressed to spontaneous vaginal delivery in each group - Proportion of women who had assisted vaginal delivery, or caesarean section - Proportion of women requiring labour augmentation with oxytocin - Duration of second stage of labour - Incidence of maternal side effects (e.g., dry mouth, tachycardia, blurred vision or any other documented adverse events). - Neonatal outcome - APGAR in 1 and 5 minutes and need for NICU admission. - Estimated blood loss	—

Measure

Time frame

- Proportion of women who progressed to spontaneous vaginal delivery in each group - Proportion of women who had assisted vaginal delivery, or caesarean section - Proportion of women requiring labour augmentation with oxytocin - Duration of second stage of labour - Incidence of maternal side effects (e.g., dry mouth, tachycardia, blurred vision or any other documented adverse events). - Neonatal outcome - APGAR in 1 and 5 minutes and need for NICU admission. - Estimated blood loss

—

Countries

Nigeria

Contacts

Public ContactDavid Peter

Senior Registrar ABUTH

dmp20032001@gmail.com+2348065126847

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Jun 29, 2026