Clinical trial NCT04349722: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
Official title: A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Long
Keywords: hyoscine
Duration of labour
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between participants who receive hyoscine and those who do not.
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Labor length
timeFrame: Through study completion until delivery up to 12 hours
Secondary outcomes:
measure: Maternal age
timeFrame: At the time of recruitment
measure: Gestational age
timeFrame: At the time of recruitment
measure: Pre-pregnancy body mass index
timeFrame: At the time of recruitment
measure: First stage of labor
timeFrame: From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours
measure: Second stage of labour
timeFrame: From cervical dilatation of 10cm until delivery of fetus
measure: Third stage of labour
timeFrame: From delivery of fetus until delivery of placenta
measure: Blood loss
timeFrame: Through study completion up to 42 days after delivery
measure: Mode of delivery
timeFrame: Through study completion up to 12 hours
measure: Analgesia
timeFrame: Through study completion until delivery up to 12 hours
measure: Pain score
timeFrame: Pre-intervention
measure: Pain score 2 hours
timeFrame: From time of intervention up to 2 hours after
measure: Pain score 4 hours
timeFrame: From time of intervention up to 4 hours after
measure: Pain score 6 hours
timeFrame: From time of intervention up to 6 hours after
measure: Neonatal outcome 1 minute
timeFrame: From delivery of neonate up to 1 minute after
measure: Neonatal outcome 5 minute
timeFrame: From delivery of neonate up to 5 minutes after
measure: Neonatal intensive care unit admission
timeFrame: From delivery of neonate up to 30 days
measure: Side effects
timeFrame: Through study completion up to 42 days after delivery
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: National University Malaysia Medical Centre
state: Kuala Lumpur
Study officials:
affiliation: National University Malaysia
name: Aida Hani Mohd Kalok
role: PRINCIPAL_INVESTIGATOR
References: