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Hyoscine-N-Butylbromide for the shortening of the Active Phase of Labour in Primigravidae: A Double Blind Randomized Placebo Controlled Trial at the University Of Uyo Teaching Hospital, Akwa-Ibom State, Nigeria

Hyoscine-N-Butylbromide for the shortening of the Active Phase of Labour in Primigravidae: A Double Blind Randomized Placebo Controlled Trial at the University Of Uyo Teaching Hospital, Akwa-Ibom State, Nigeria

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202111520130772
Enrollment
100
Registered
2021-11-29
Start date
2021-11-22
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Pregnancy and Childbirth

Interventions

hyoscinenbutylbromide

Sponsors

DR ANIEKAN JACKSON
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: a. First time pregnant mothers b. Aged 20-35 years c. Gestational age of 37 to 41 weeks d. Singleton foetus in cephalic presentation e. Spontaneous onset of labour. f. Active phase labour(cervical dilatation of 5cm to 7cm) g. Spontaneous rupture of membranes < 2hours

Exclusion criteria

Exclusion criteria: a. Maternal age below 20 and above 35 years b. Referred and unbooked mothers c. Multiple pregnancies d. Previous uterine scar e. Foetal Malpresentation f. Antepartum haemorrhage g. Induced labour h. Rupture of foetal membranes (>2 hours) i. Contraindications to vaginal delivery, j. Mothers on cervical cerclage, k. Maternal pyrexia and l. Allergy to HBB m. Co-morbidities like pre-eclampsia, cardiac, renal and liver disorders, asthma, sicklers, epilepsy, hypertension and diabetes mellitus n. History of infertility. o. Absolute contraindications to HBB like paralytic ileus, intestinal obstruction, myasthenia gravis, mechanical gastrointestinal tract stenosis p. Down’s syndrome q. Hyperthyroidism r. Heart failure s. Gastro-oesophageal reflux disease (GERD) t. Urinary incontinence u. Severe constipation v. Untreated narrow angle glaucoma w. Allergy to belladonna alkaloids x. Megacolon/Hirschsprung’s disease y. Prostatic hypertrophy with urinary retention

Design outcomes

Primary

MeasureTime frame
duration of active phase of labour

Secondary

MeasureTime frame
duration of second and third stage of labour, analgesic effect, maternal side effects, Caesarean section rate, cervical laceration rate, estimated blood loss post delivery, fetal outcome

Countries

Nigeria

Contacts

Public ContactNSIKAK NYOYOKO

professional consultant

nsikokobest@gmail.com2348037081997

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026