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Completed

NCT Number: NCT04349722

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

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

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Key information

Conditions

Labor Long

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

National University Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hyoscine Butylbromide

Drug

Intervention is given once a participant is in established labor

Other names: Buscopan

Placebo

Other

Intervention is given once a participant is in established labor

Primary outcomes

  1. Labor length

    Time frame: Through study completion until delivery up to 12 hours

    Duration of labor

Secondary outcomes

  1. Maternal age

    Time frame: At the time of recruitment

    Mean maternal age in years

  2. Gestational age

    Time frame: At the time of recruitment

    Mean gestational age in weeks

  3. Pre-pregnancy body mass index

    Time frame: At the time of recruitment

    Mean body mass index in kg/m2

  4. First stage of labor

    Time frame: 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

    Time frame: From cervical dilatation of 10cm until delivery of fetus

    Mean duration of second stage of labour in hours

  6. Third stage of labour

    Time frame: From delivery of fetus until delivery of placenta

    Mean duration of third stage of labour in hours

  7. Blood loss

    Time frame: Through study completion up to 42 days after delivery

    Mean blood loss in millilitres

  8. Mode of delivery

    Time frame: Through study completion up to 12 hours

    Percentage of participants who delivered vaginally or via caesarean section

  9. Analgesia

    Time frame: Through study completion until delivery up to 12 hours

    Percentage of women need analgesia

  10. Pain score

    Time frame: Pre-intervention

    Mean pain score

  11. Pain score 2 hours

    Time frame: From time of intervention up to 2 hours after

    Mean pain score at 2 hours

  12. Pain score 4 hours

    Time frame: From time of intervention up to 4 hours after

    Mean pain score at 4 hours

  13. Pain score 6 hours

    Time frame: From time of intervention up to 6 hours after

    Mean pain score at 6 hours

  14. Neonatal outcome 1 minute

    Time frame: From delivery of neonate up to 1 minute after

    Mean apgar score at 1 minute

  15. Neonatal outcome 5 minute

    Time frame: From delivery of neonate up to 5 minutes after

    Mean apgar score at 1 minute

  16. Neonatal intensive care unit admission

    Time frame: From delivery of neonate up to 30 days

    Percentage of neonates require admission to neonatal intensive care unit admission

  17. Side effects

    Time frame: Through study completion up to 42 days after delivery

    Percentage of participants who develop side effects to treatment

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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