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

Phase 1

Recruiting

• Conditions: Pregnancy and Childbirth

• Registration Number: PACTR202111520130772
• Lead Sponsor: DR ANIEKAN JACKSO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
duration of active phase of labour

Secondary Outcome Measures

Name	Time	Method
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