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This study compares the duration of active phase of labour in women who received buscopan and those who don't.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyoscine | Active Comparator | Participants receive intravenous bolus of 1ml (20 mg) Hyoscine |
|
| Placebo | Placebo Comparator | Participants receive intravenous bolus of 1ml normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyoscine Butylbromide | Drug | Intervention is given once a participant is in established labor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Labor length | Duration of labor | Through study completion until delivery up to 12 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aida Hani Mohd Kalok | National University Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Malaysia Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
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Comparison between participants who receive hyoscine and those who do not.
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Participants and care provider are blinded from the treatment
| Placebo | Other | Intervention is given once a participant is in established labor |
|
| 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 |
| D014326 |
| Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |