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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04349722
Other study ID # FF-2019-521
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 1, 2019
Est. completion date June 30, 2020

Study information

Verified date April 2022
Source National University of Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hyoscine Butylbromide
Intervention is given once a participant is in established labor
Other:
Placebo
Intervention is given once a participant is in established labor

Locations

Country Name City State
Malaysia National University Malaysia Medical Centre Cheras Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

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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