Labor Long Clinical Trial
Official title:
A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
Verified date | April 2022 |
Source | National University of Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compares the duration of active phase of labour in women who received buscopan and those who don't.
Status | Completed |
Enrollment | 110 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Malaysia | National University Malaysia Medical Centre | Cheras | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
National University of Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Labor length | Duration of labor | Through study completion until delivery up to 12 hours | |
Secondary | Maternal age | Mean maternal age in years | At the time of recruitment | |
Secondary | Gestational age | Mean gestational age in weeks | At the time of recruitment | |
Secondary | Pre-pregnancy body mass index | Mean body mass index in kg/m2 | At the time of recruitment | |
Secondary | 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 | |
Secondary | Second stage of labour | Mean duration of second stage of labour in hours | From cervical dilatation of 10cm until delivery of fetus | |
Secondary | Third stage of labour | Mean duration of third stage of labour in hours | From delivery of fetus until delivery of placenta | |
Secondary | Blood loss | Mean blood loss in millilitres | Through study completion up to 42 days after delivery | |
Secondary | Mode of delivery | Percentage of participants who delivered vaginally or via caesarean section | Through study completion up to 12 hours | |
Secondary | Analgesia | Percentage of women need analgesia | Through study completion until delivery up to 12 hours | |
Secondary | Pain score | Mean pain score | Pre-intervention | |
Secondary | Pain score 2 hours | Mean pain score at 2 hours | From time of intervention up to 2 hours after | |
Secondary | Pain score 4 hours | Mean pain score at 4 hours | From time of intervention up to 4 hours after | |
Secondary | Pain score 6 hours | Mean pain score at 6 hours | From time of intervention up to 6 hours after | |
Secondary | Neonatal outcome 1 minute | Mean apgar score at 1 minute | From delivery of neonate up to 1 minute after | |
Secondary | Neonatal outcome 5 minute | Mean apgar score at 1 minute | From delivery of neonate up to 5 minutes after | |
Secondary | Neonatal intensive care unit admission | Percentage of neonates require admission to neonatal intensive care unit admission | From delivery of neonate up to 30 days | |
Secondary | Side effects | Percentage of participants who develop side effects to treatment | Through study completion up to 42 days after delivery |
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