The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
- Registration Number
- NCT04349722
- Lead Sponsor
- National University of Malaysia
- Brief Summary
This study compares the duration of active phase of labour in women who received buscopan and those who don't.
- Detailed 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants receive intravenous bolus of 1ml normal saline Hyoscine Hyoscine Butylbromide Participants receive intravenous bolus of 1ml (20 mg) Hyoscine
- Primary Outcome Measures
Name Time Method Labor length Through study completion until delivery up to 12 hours Duration of labor
- Secondary Outcome Measures
Name Time Method Blood loss Through study completion up to 42 days after delivery Mean blood loss in millilitres
Pain score Pre-intervention Mean pain score
Pain score 6 hours From time of intervention up to 6 hours after Mean pain score at 6 hours
Neonatal intensive care unit admission From delivery of neonate up to 30 days Percentage of neonates require admission to neonatal intensive care unit admission
Side effects Through study completion up to 42 days after delivery Percentage of participants who develop side effects to treatment
Pre-pregnancy body mass index At the time of recruitment Mean body mass index in kg/m2
Neonatal outcome 5 minute From delivery of neonate up to 5 minutes after Mean apgar score at 1 minute
Maternal age At the time of recruitment Mean maternal age in years
First stage of labor From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours Mean duration of first stage of labor in hours
Second stage of labour From cervical dilatation of 10cm until delivery of fetus Mean duration of second stage of labour in hours
Third stage of labour From delivery of fetus until delivery of placenta Mean duration of third stage of labour in hours
Mode of delivery Through study completion up to 12 hours Percentage of participants who delivered vaginally or via caesarean section
Neonatal outcome 1 minute From delivery of neonate up to 1 minute after Mean apgar score at 1 minute
Gestational age At the time of recruitment Mean gestational age in weeks
Pain score 2 hours From time of intervention up to 2 hours after Mean pain score at 2 hours
Analgesia Through study completion until delivery up to 12 hours Percentage of women need analgesia
Pain score 4 hours From time of intervention up to 4 hours after Mean pain score at 4 hours
Trial Locations
- Locations (1)
National University Malaysia Medical Centre
🇲🇾Cheras, Kuala Lumpur, Malaysia