Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women (NCT03055390) | Clinical Trial Compass
CompletedPhase 4
Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women
Egypt300 participantsStarted 2017-02-11
Plain-language 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).
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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Inclusion criteria
✓. Age: 18 - 35 years old
✓. Primigravdae or multigravida
✓. Gestational age between completed 37- 41 weeks + 6 days.
✓. 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
. 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.