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

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

Detailed Description
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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)

Official Title
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A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae

Conditions
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Labor Long

Intervention / Treatment
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* Drug: Hyoscine Butylbromide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison between participants who receive hyoscine and those who do not.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyoscine<br>Participants receive intravenous bolus of 1ml (20 mg) Hyoscine | Drug: Hyoscine Butylbromide<br>* Intervention is given once a participant is in established labor<br>* Other names: Buscopan;|
| Placebo Comparator: Placebo<br>Participants receive intravenous bolus of 1ml normal saline | Other: Placebo<br>* Intervention is given once a participant is in established labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labor length | Duration of labor | Through study completion until delivery up to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal age | Mean maternal age in years | At the time of recruitment | 
| Gestational age | Mean gestational age in weeks | At the time of recruitment | 
| Pre-pregnancy body mass index | Mean body mass index in kg/m2 | At the time of recruitment | 
| First stage of labor | Mean duration of first stage of labor in hours | From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours | 
| Second stage of labour | Mean duration of second stage of labour in hours | From cervical dilatation of 10cm until delivery of fetus | 
| Third stage of labour | Mean duration of third stage of labour in hours | From delivery of fetus until delivery of placenta | 
| Blood loss | Mean blood loss in millilitres | Through study completion up to 42 days after delivery | 
| Mode of delivery | Percentage of participants who delivered vaginally or via caesarean section | Through study completion up to 12 hours | 
| Analgesia | Percentage of women need analgesia | Through study completion until delivery up to 12 hours | 
| Pain score | Mean pain score | Pre-intervention | 
| Pain score 2 hours | Mean pain score at 2 hours | From time of intervention up to 2 hours after | 
| Pain score 4 hours | Mean pain score at 4 hours | From time of intervention up to 4 hours after | 
| Pain score 6 hours | Mean pain score at 6 hours | From time of intervention up to 6 hours after | 
| Neonatal outcome 1 minute | Mean apgar score at 1 minute | From delivery of neonate up to 1 minute after | 
| Neonatal outcome 5 minute | Mean apgar score at 1 minute | From delivery of neonate up to 5 minutes after | 
| Neonatal intensive care unit admission | Percentage of neonates require admission to neonatal intensive care unit admission | From delivery of neonate up to 30 days | 
| Side effects | Percentage of participants who develop side effects to treatment | Through study completion up to 42 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyoscine, Duration of labour