The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae

A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae

Sponsors

Lead Sponsor: National University of Malaysia

Source National University of Malaysia
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)

Overall Status Recruiting
Start Date December 1, 2019
Completion Date June 30, 2020
Primary Completion Date June 30, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Labor length Through study completion until delivery up to 12 hours
Secondary Outcome
Measure Time Frame
Maternal age At the time of recruitment
Gestational age At the time of recruitment
Pre-pregnancy body mass index At the time of recruitment
First stage of labor From onset of regular contraction to cervical dilatation of 10 cm up to 24 hours
Second stage of labour From cervical dilatation of 10cm until delivery of fetus
Third stage of labour From delivery of fetus until delivery of placenta
Blood loss Through study completion up to 42 days after delivery
Mode of delivery Through study completion up to 12 hours
Analgesia Through study completion until delivery up to 12 hours
Pain score Pre-intervention
Pain score 2 hours From time of intervention up to 2 hours after
Pain score 4 hours From time of intervention up to 4 hours after
Pain score 6 hours From time of intervention up to 6 hours after
Neonatal outcome 1 minute From delivery of neonate up to 1 minute after
Neonatal outcome 5 minute From delivery of neonate up to 5 minutes after
Neonatal intensive care unit admission From delivery of neonate up to 30 days
Side effects Through study completion up to 42 days after delivery
Enrollment 110
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hyoscine Butylbromide

Description: Intervention is given once a participant is in established labor

Arm Group Label: Hyoscine

Other Name: Buscopan

Intervention Type: Other

Intervention Name: Placebo

Description: Intervention is given once a participant is in established labor

Arm Group Label: Placebo

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)

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Aida Hani Mohd Kalok Principal Investigator National University Malaysia
Overall Contact

Last Name: Rahana Abd Rahman

Phone: +60122719985

Email: [email protected]

Location
Facility: Status: Contact: National University Malaysia Medical Centre Jemaima Che Hamzah [email protected]
Location Countries

Malaysia

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National University of Malaysia

Investigator Full Name: Rahana Abd Rahman

Investigator Title: Co-primary investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Hyoscine

Type: Active Comparator

Description: Participants receive intravenous bolus of 1ml (20 mg) Hyoscine

Label: Placebo

Type: Placebo Comparator

Description: Participants receive intravenous bolus of 1ml normal saline

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Comparison between participants who receive hyoscine and those who do not.

Primary Purpose: Treatment

Masking: Double (Participant, Care Provider)

Masking Description: Participants and care provider are blinded from the treatment

Source: ClinicalTrials.gov