Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Vaginal delivery
研究概览
简要总结
The purpose of this study is to evaluate the blood loss in induced vaginal delivery by misoprostol and caesarians section with induction attempt.
详细描述
Methods: it was a study achieved with 101 pregnant women with indication to induced delivery labor that were evaluated by the hemoglobin dosage pre and post delivery for estimate the blood loss at delivery. Patients were submitted to transabdominal obstetric ultrasound and basal cardiotocography. Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six. The control group was formed by 30 patients that began an spontaneously labor and 30 patients that achieved caesarians electively. The study of hemoglobin before and after delivery was evaluated through ANOVA to repeated measures, where it was verified the time effect (pre and post delivery) and the effect of the group (with and without use of misoprostol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Indication of early elective delivery by induction of labor (pre-eclampsia, HELLP syndrome, chronic hypertension, prolonged gestation, diabetes mellitus, gestational diabetes, heart disease, thyroid disease;
- •pregnancy with living fetus;
- •vertex cephalic presentation;
- •estimated fetal weight by ultrasound > 2500g and <4000g;
- •Amniotic fluid index (AFI)> 5 cm, except in cases of premature rupture of membranes in which AFI <5 cm would be allowed;
- •cardiotocography (CTG) antepartum normal;
- •Bishop Score less than or equal to 6;
- •Determination of hemoglobin pre and post-partum.
排除标准
- •Prior Cesarean section;
- •previous uterine scar by myomectomy;
- •Fetal presentation anomalous;
- •Evidence of fetal abnormal (CTG, Ultrasound or Doppler);
- •Fetal growth restriction;
- •Gestation multiple;
- •genital bleeding;
- •tumors, malformations and / or ulceration in the region vulvoperineal and birth canal;
- •No determination of hemoglobin pre-and post-partum;
研究组 & 干预措施
spontaneous vaginal deliveries
干预措施: Misoprostol (Drug)
elective caesarians
干预措施: Misoprostol (Drug)
induced vaginal delivery by misoprostol
干预措施: Misoprostol (Drug)
caesarians section with induction attempt
干预措施: Misoprostol (Drug)
结局指标
主要结局
Vaginal delivery
时间窗: 54 hours after the first pills
Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
次要结局
- blood loss(24 hours after delivery)