NCT03055390

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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).

Conditions

• Vaginal Delivery

Interventions

Type	Name	Description
DRUG	hyoscine butylbromide	Intravenous administration of hyoscine butylbromide during first stage of labor
DRUG	placebo	2ml of saline intravenous

Timeline

• Start date: 2017-02-11
• Primary completion: 2022-01-10
• Completion: 2022-02-03
• First posted: 2017-02-16
• Last updated: 2022-03-10

Locations

1 site across 1 country: Egypt