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NCT Number: NCT02824679

Effect of Intravenous Hyoscine Butylbromide Injection on First Stage Labour in Primigavidae

A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18 - 35 years old
  • Primigravdae.
  • Gestational age between completed 37- 41 weeks + 6 days.
  • Uncomplicated cephalic singleton pregnancy occipto-anterior position.
  • Established spontaneous active labour (defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation three to four centimeters) with cervical effacement not less than 50%.
  • Intact amniotic membranes.

Exclusion criteria

  • Multigravidae.
  • Multiple fetus.
  • Malpresentation.
  • Patients with indications of elective caesarean section.
  • Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus.
  • Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma.
  • Patients presented to causality with spontaneous rupture of membranes.
  • Spontaneous rupture of membranes during the active phase of first stage of labour.
  • Oxytocin induction or augmentation.
  • Patients who underwent epidural anesthesia or other types of analgesia.

Treatment and study plan

Hyoscine Butylbromide

Drug

20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor

Saline

Drug

0.9%normal saline

Primary outcomes

  1. first stage duration

    Time frame: 12 hours after drug intake

    time till cervix become fully dilated

Secondary outcomes

  1. Mode of delivery

    Time frame: 12 hours after drug intake

    Normal vaginal or cesarean section

Sponsors and collaborators

Lead sponsor

Ahmed M Maged, MD

Other

Registry information

Official study title

Effect of Intravenous Hyoscine Butylbromide Injection on the Course and Duration of First Stage of Labour in Primigavidae

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 7, 2016
Registry last updated
Dec 14, 2021

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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