Effectiveness of Hyoscine Butyl Bromide on Duration of Active Phase of Labour among Primigravida's in Uganda.

Effectiveness of Hyoscine Butyl Bromide on Duration of Active Phase of Labour and Related Maternal and Perinatal Outcomes among Primigravida's at Lira and Hoima Regional Referral Hospitals: A Randomized Controlled Trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202601714326960

Enrollment

240

Registered

2026-01-26

Start date

2026-01-12

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

Pregnancy and Childbirth

Interventions

Normal Saline

Hyoscine Butyl Bromide

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Primigravida women Singleton pregnancy Gestational age =37 completed weeks Spontaneous onset of labour Active phase of labour (cervical dilatation =5 cm) Cephalic presentation Age between 19 and 44 years Receiving care at Lira or Hoima Regional Referral Hospitals Provided written informed consent

Exclusion criteria

Exclusion criteria: Multigravida women Multiple pregnancy Preterm labour (<37 weeks gestation) Induced labour Previous uterine surgery Medical or obstetric complications (e.g. preeclampsia, diabetes mellitus) Malpresentation Intrauterine fetal demise Known hypersensitivity to hyoscine butyl bromide Need for immediate operative delivery medical condition e.g hypertension and diabetes

Design outcomes

Secondary

Measure	Time frame
Secondary Outcome 1 Outcome: Mode of delivery (spontaneous vaginal delivery, assisted vaginal delivery, or caesarean section). ;Secondary Outcome 2 Outcome: Need for oxytocin augmentation during labour. ;Secondary Outcome 3 Outcome: Maternal adverse effects including tachycardia, dry mouth, nausea, vomiting, and dizziness. ;Secondary Outcome 4 Outcome: Occurrence of postpartum hemorrhage. ; Non-reassuring fetal heart rate patterns. ;Secondary Outcome 6 Low Apgar score at 5 minutes (<7) ;Secondary Outcome 7 Outcome: Early neonatal outcomes including need for neonatal resuscitation or admission to the neonatal unit and early neonatal death.	—

Measure

Time frame

Secondary Outcome 1 Outcome: Mode of delivery (spontaneous vaginal delivery, assisted vaginal delivery, or caesarean section). ;Secondary Outcome 2 Outcome: Need for oxytocin augmentation during labour. ;Secondary Outcome 3 Outcome: Maternal adverse effects including tachycardia, dry mouth, nausea, vomiting, and dizziness. ;Secondary Outcome 4 Outcome: Occurrence of postpartum hemorrhage. ; Non-reassuring fetal heart rate patterns. ;Secondary Outcome 6 Low Apgar score at 5 minutes (<7) ;Secondary Outcome 7 Outcome: Early neonatal outcomes including need for neonatal resuscitation or admission to the neonatal unit and early neonatal death.

—

Primary

Measure	Time frame
Duration of the active phase of labour measured in hours from cervical dilatation of 5 cm to full cervical dilatation (10 cm).	—

Countries

Uganda

Contacts

Public ContactAisha Abdullahi Ahmed

obgyn resident

ahmed.aisha@studwc.kiu.ac.ug+256744950784

Outcome results

None listed

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