The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae

N

National University of Malaysia

Status and phase

Completed
Phase 4

Conditions

Labor Long

Treatments

Other: Placebo
Drug: Hyoscine Butylbromide

Study type

Interventional

Funder types

Other

Identifiers

NCT04349722
FF-2019-521

Details and patient eligibility

About

This study compares the duration of active phase of labour in women who received buscopan and those who don't.

Full description

A randomised control study involving primigravida in labour who require pitocin augmentation. Once patient require augmentation, patient will be randomised into intervention group (receiving intravenous buscopan 1ml or 20mg) and control group (intravenous normal saline 1ml). Both fluids are colourless. The primary outcome is duration from augmentation to os fully. The secondary outcome are to look on mode of delivery particularly any caesarean section due to failure to poor progress, maternal side effect (dry mouth and tachycardia) and baby outcome (apgar score and neonatal intensive care unit admission)

Enrollment

110 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Primigravida
  • Vertex presentation
  • Term gestation (37-41w)
  • Active phase of labor (4cm with regular contraction at least 2:10)
  • Spontaneous labor
  • Oxytocin augmentation
  • Maternal height ≥150cm

Exclusion criteria

  • Multiple pregnancies
  • Previous uterine surgery
  • Hypertensive disease in pregnancy
  • Gestational diabetes on treatment
  • Clinical estimation of fetal weight >3.8kg
  • Induction of labor
  • Meconium stained liquor
  • Allergy to hyoscine
  • Medical contraindication to hyoscine (i.e Myasthenia gravis, glaucoma, megacolon)

Trial design

110 participants in 2 patient groups, including a placebo group

Hyoscine
Active Comparator group
Description:
Participants receive intravenous bolus of 1ml (20 mg) Hyoscine
Treatment:
Drug: Hyoscine Butylbromide
Placebo
Placebo Comparator group
Description:
Participants receive intravenous bolus of 1ml normal saline
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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