Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Duration of the first stage of labour
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
They received two ml of normal saline intravenously as a placebo
干预措施: placebo (Drug)
20 mg hyoscine butylbromide
They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
干预措施: hyoscine butylbromide (Drug)
40 mg hyoscine butylbromide
They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
干预措施: hyoscine butylbromide (Drug)
结局指标
主要结局
Duration of the first stage of labour
时间窗: 24 hours
Duration of the first stage of labour
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
Assistant professor
Cairo University