Effect of Intravenous Hyoscine Butylbromide Injection on the Course and Duration of First Stage of Labour in Primigavidae
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- first stage duration
研究概览
简要总结
A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed
详细描述
A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- 否
入选标准
- •Age: 18 - 35 years old
- •Primigravdae.
- •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.
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
20mg hyoscine butylbromide
They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
干预措施: hyoscine butylbromide (Drug)
20mg hyoscine butylbromide
They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
干预措施: saline (Drug)
40 mg hyoscine butylbromide
They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
干预措施: hyoscine butylbromide (Drug)
Saline
They received two ml of normal saline intravenously as a placebo
干预措施: saline (Drug)
结局指标
主要结局
first stage duration
时间窗: 12 hours after drug intake
time till cervix become fully dilated
次要结局
- Mode of delivery(12 hours after drug intake)
研究者
Ahmed M Maged, MD
Assistant professor
Cairo University