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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03055390
Enrollment
300
Registered
2017-02-16
Start date
2017-02-11
Completion date
2022-02-03
Last updated
2022-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Delivery

Keywords

hyoscine butylbromide, progress of labor, duration of labor

Brief summary

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).

Detailed description

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: 1. 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. 2. General examination of the patients including (pulse, blood pressure, temperature). 3. Obstetric Abdominal examination including fetal lie, fetal presentation, head station and uterine contractions. 4. Vaginal examination including cervical dilatation, effacement and position, state of fetal membranes, presenting part, position of fetal head and pelvic adequacy. 5. 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).

Interventions

Intravenous administration of hyoscine butylbromide during first stage of labor

DRUGplacebo

2ml of saline intravenous

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age: 18 - 35 years old 2. Primigravdae or multigravida 3. Gestational age between completed 37- 41 weeks + 6 days. 4. Uncomplicated cephalic singleton pregnancy occipto-anterior position. 5. 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%. 6. Intact amniotic membranes. 7. High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus

Exclusion criteria

1. Multigravidae. 2. Multiple fetus. 3. Malpresentation. 4. Patients with indications of elective caesarean section. 5. Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus. 6. Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma. 7. Patients presented to causality with spontaneous rupture of membranes. 8. Spontaneous rupture of membranes during the active phase of first stage of labour. 9. Oxytocin induction or augmentation. 10. Patients who underwent epidural anesthesia or other types of analgesia

Design outcomes

Primary

MeasureTime frameDescription
Duration of the first stage of labour24 hoursDuration of the first stage of labour

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026