Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women
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About
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).
Full 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:
- 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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
300 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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