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

Sponsor
National University of Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT04349722
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
15.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyoscine Butylbromide
  • Other: Placebo
 Phase 4

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Comparison between participants who receive hyoscine and those who do not.Comparison between participants who receive hyoscine and those who do not.
Masking:
Double (Participant, Care Provider)
Masking Description:
Participants and care provider are blinded from the treatment
Primary Purpose:
Treatment
Official Title:
A Randomised Control Study: The Effect of Hyoscine-N-butylbromide (HBB, Buscopan) in Augmented Labour Among Primigravidae
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hyoscine

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

Drug: Hyoscine Butylbromide
Intervention is given once a participant is in established labor
Other Names:
  • Buscopan

    		•
    Placebo Comparator: Placebo

    Participants receive intravenous bolus of 1ml normal saline

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

    Outcome Measures

    Primary Outcome Measures

    1. Labor length [Through study completion until delivery up to 12 hours]

      Duration of labor

    Secondary Outcome Measures

    1. Maternal age [At the time of recruitment]

      Mean maternal age in years

    2. Gestational age [At the time of recruitment]

      Mean gestational age in weeks

    3. Pre-pregnancy body mass index [At the time of recruitment]

      Mean body mass index in kg/m2

    4. 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

    5. Second stage of labour [From cervical dilatation of 10cm until delivery of fetus]

      Mean duration of second stage of labour in hours

    6. Third stage of labour [From delivery of fetus until delivery of placenta]

      Mean duration of third stage of labour in hours

    7. Blood loss [Through study completion up to 42 days after delivery]

      Mean blood loss in millilitres

    8. Mode of delivery [Through study completion up to 12 hours]

      Percentage of participants who delivered vaginally or via caesarean section

    9. Analgesia [Through study completion until delivery up to 12 hours]

      Percentage of women need analgesia

    10. Pain score [Pre-intervention]

      Mean pain score

    11. Pain score 2 hours [From time of intervention up to 2 hours after]

      Mean pain score at 2 hours

    12. Pain score 4 hours [From time of intervention up to 4 hours after]

      Mean pain score at 4 hours

    13. Pain score 6 hours [From time of intervention up to 6 hours after]

      Mean pain score at 6 hours

    14. Neonatal outcome 1 minute [From delivery of neonate up to 1 minute after]

      Mean apgar score at 1 minute

    15. Neonatal outcome 5 minute [From delivery of neonate up to 5 minutes after]

      Mean apgar score at 1 minute

    16. Neonatal intensive care unit admission [From delivery of neonate up to 30 days]

      Percentage of neonates require admission to neonatal intensive care unit admission

    17. Side effects [Through study completion up to 42 days after delivery]

      Percentage of participants who develop side effects to treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National University Malaysia Medical Centre Cheras Kuala Lumpur Malaysia 56000

    Sponsors and Collaborators

    • National University of Malaysia

    Investigators

    • Principal Investigator: Aida Hani Mohd Kalok, National University Malaysia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rahana Abd Rahman, Co-primary investigator, National University of Malaysia
    ClinicalTrials.gov Identifier:
    NCT04349722
    Other Study ID Numbers:
    • FF-2019-521
    First Posted:
    Apr 16, 2020
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Rahana Abd Rahman, Co-primary investigator, National University of Malaysia
    hyoscine
    Duration of labour
    Additional relevant MeSH terms:
    Scopolamine
    Butylscopolammonium Bromide

    Study Results

    No Results Posted as of Apr 6, 2022