Labor Long
Conditions
Keywords
hyoscine, Duration of labour
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)
Interventions
Intervention is given once a participant is in established labor
OTHERPlacebo
Intervention is given once a participant is in established labor
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participants and care provider are blinded from the treatment
Intervention model description
Comparison between participants who receive hyoscine and those who do not.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Labor length | Through study completion until delivery up to 12 hours | Duration of labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | Through study completion up to 42 days after delivery | Percentage of participants who develop side effects to treatment |
| 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 |
| Gestational age | At the time of recruitment | Mean gestational age in weeks |
| Pre-pregnancy body mass index | At the time of recruitment | Mean body mass index in kg/m2 |
| 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 |
| Neonatal intensive care unit admission | From delivery of neonate up to 30 days | Percentage of neonates require admission to neonatal intensive care unit admission |
| Mode of delivery | Through study completion up to 12 hours | Percentage of participants who delivered vaginally or via caesarean section |
| Analgesia | Through study completion until delivery up to 12 hours | Percentage of women need analgesia |
| Pain score | Pre-intervention | Mean pain score |
| Pain score 2 hours | From time of intervention up to 2 hours after | Mean pain score at 2 hours |
| Pain score 4 hours | From time of intervention up to 4 hours after | Mean pain score at 4 hours |
| Pain score 6 hours | From time of intervention up to 6 hours after | Mean pain score at 6 hours |
| Neonatal outcome 1 minute | From delivery of neonate up to 1 minute after | Mean apgar score at 1 minute |
| Blood loss | Through study completion up to 42 days after delivery | Mean blood loss in millilitres |
Countries
Malaysia
Outcome results
None listed