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Completed

NCT Number: NCT03055390

Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women

A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.

Patients were divided into three equal groups:

Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.

Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.

Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kasr Alainy medical school

Cairo, 12151, Egypt

About this study

A case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.

For each patient:

  • Complete history was taking to exclude allergy to hyoscine butylbromide, medical disorders with pregnancy (preeclampsia, diabetes mellitus, heart disease …etc.) and any contraindication for vaginal delivery.
  • General examination of the patients including (pulse, blood pressure, temperature).
  • Obstetric Abdominal examination including fetal lie, fetal presentation, head station and uterine contractions.
  • Vaginal examination including cervical dilatation, effacement and position, state of fetal membranes, presenting part, position of fetal head and pelvic adequacy.
  • Obstetric ultrasound to detect fetal gestational age, fetal birth weight amount of liquor, site of placental attachment and fetal heart rate.

Patients were divided into three equal groups:

Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.

Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.

Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 18 - 35 years old
  • Primigravdae or multigravida
  • 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.
  • High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus

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

Intravenous administration of hyoscine butylbromide during first stage of labor

Other names: Dospa

Placebo

Drug

2ml of saline intravenous

Other names: saline

Primary outcomes

  1. Duration of the first stage of labour

    Time frame: 24 hours

    Duration of the first stage of labour

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2017
Registry last updated
Mar 10, 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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