Effect of a Medication (Hyoscine) Taken by Mouth to Help Prepare the Cervix for Labour in First-Time Pregnant Women at Term at Olabisi Onabanjo University Teaching Hospital, Sagamu.

Efficacy of Oral Hyoscine N-Butyl Bromide for Outpatient Cervical Ripening in Nulliparous Women at Term: A Double-Blind Randomized Controlled Trial at Olabisi Onabanjo University Teaching Hospital, Sagamu.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202605759587564

Enrollment

120

Registered

2026-05-28

Start date

2026-06-01

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

Cervical ripening

Interventions

Hyoscine N Butyl Bromide

Folinic acid

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Nulliparity: Age 18–34 years: Singleton pregnancy in cephalic (vertex) presentation. Intact fetal membranes No regular uterine contractions or not in labour Unfavourable cervix, defined as a Bishop score = 5 on digital examination. Reactive NST (Non-Stress Test) Able to comply with outpatient regimen and follow-up Informed consent given Willingness to be delivered in the teaching hospital

Exclusion criteria

Exclusion criteria: Multiple gestation or non-vertex presentation: Any indication for immediate delivery: e.g. severe preeclampsia with severe features, antepartum haemorrhage, chorioamnionitis, or any condition where waiting for cervical ripening is unsafe. Pre-labor rupture of membranes (PROM) Prior uterine surgery: Placental or fetal contraindications to labor: e.g. placenta previa or vasa previa (necessitating cesarean), known major fetal anomaly or suspected macrosomia =4.5 kg Intrauterine fetal demise Contraindications to vagina delivery Abnormal fetal heart rate tracing: Non-reactive NST Medical complications requiring inpatient care: Allergy or contraindication to hyoscine N-butyl bromide: Refusal or inability to consent

Design outcomes

Primary

Measure	Time frame
The primary outcome is the Bishop score at hospital admission (or labour onset, if spontaneous) as a measure of cervical ripeness. Analysis will compare the mean Bishop score between the hyoscine and placebo groups, as well as the proportion of women achieving a favourable cervix (=6).	—

Secondary

Measure	Time frame
Secondary outcomes include rate of spontaneous labour before 41 weeks, need for additional inpatient cervical ripening (e.g. Foley catheter or prostaglandin), induction to delivery interval in hours, duration of active labour, mode of delivery (vaginal vs cesarean including indication), oxytocin use (need and cumulative dose/time), maternal outcomes (including postpartum haemorrhage, chorioamnionitis, anticholinergic side effects such as dry mouth or tachycardia), and neonatal outcomes (5 min Apgar <7, NICU admission, birth weight). Process metrics include adherence rate (based on pill count and diary), protocol deviations, loss to follow up, and any emergency unblinding events.	—

Measure

Time frame

Secondary outcomes include rate of spontaneous labour before 41 weeks, need for additional inpatient cervical ripening (e.g. Foley catheter or prostaglandin), induction to delivery interval in hours, duration of active labour, mode of delivery (vaginal vs cesarean including indication), oxytocin use (need and cumulative dose/time), maternal outcomes (including postpartum haemorrhage, chorioamnionitis, anticholinergic side effects such as dry mouth or tachycardia), and neonatal outcomes (5 min Apgar <7, NICU admission, birth weight). Process metrics include adherence rate (based on pill count and diary), protocol deviations, loss to follow up, and any emergency unblinding events.

—

Countries

Nigeria

Contacts

Public ContactOLUSOJI JAGUN

HEAD OF DEPARTMENT AT OLABISI ONABANJO UNIVERSITY

jagun.olusoji@oouagoiwoye.edu.ng+2348037190490

Outcome results

None listed

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