The Effect of Placental Removal Method and Uterine Massage at Cesarean Delivery on Preventing Postpartum Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 361
- 试验地点
- 1
- 主要终点
- Comparison of patients' postoperative shock indexes
研究概览
简要总结
Postpartum hemorrhage is the leading cause of maternal deaths in all over the world, especially in developing and underdeveloped countries. Medical and surgical methods exist for management of bleeding.
There are two surgical techniques for removal of the placenta on cesarean delivery, which are called manual removal and controlled cord traction. In manual removal group, the duration of surgery time might be shorter theoretically. Nevertheless, there are studies showing that manual removal of the placenta may increase postpartum endometritis and postpartum hemorrhage. The optimal method for removal of the placenta during the cesarean delivery remains uncertain (1).
It is a known fact that uterine massage after vaginal birth lowers the risk of postpartum hemorrhage (2) However, there is no study on how effective uterine massage is during cesarean delivery. In 2018, Saccone and colleagues wanted to publish a meta-analysis on the role of uterine massage in reducing postpartum bleeding during cesarean delivery, but when they examined the literature on the subject, they could not find a study which included only the group that gave birth by cesarean section and was free from bias. In the same publication, it was mentioned that it was necessary to investigate the effectiveness of uterine massage, which is a cost-free method that can reduce maternal morbidity in underdeveloped countries where maternal deaths due to postpartum bleeding are high, in cesarean section. (3)
详细描述
In this study, data of patients who underwent emergency cesarean delivery in the Department of Obstetrics and Gynecology, Ankara Etlik City Hospital, will be collected
The parameters to be examined in the research are as follows:
- Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
- Volume of diuresis at postoperative first six hours
- Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
- Duration of the surgery.
- Need for additional dose of uterotonics
- Need for surgical methods to manage postpartum bleeding
- Duration of hospital stay
The sample size of this study was calculated with the Gpower3.1 computer program.
The total number of samples with 90% power and 95% confidence interval was calculated as 338 patients. The number of volunteers to participate in our study is planned to be 360 in total, 60 volunteers for each group, across 6 groups. Results will be considered statistically significant for p< 0,05.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Live singleton pregnancy of 37 0/7 weeks or more
- •Without history of previous uterine atony
- •No comorbidities
- •No gestational hypertension or gestational diabetes mellitus
排除标准
- •In utero fetal death
- •Multiple gestation
- •History of uterine atony
- •Vaginal birth
- •Previous history of cesarean delivery
结局指标
主要结局
Comparison of patients' postoperative shock indexes
时间窗: 2 hours
Postoperative 30th minute, 1st and 2nd hour shock indices (heart rate (beats per minute) / systolic blood pressure(mmHg) ) will be compared
Comparison of patients' preoperative and postoperative hemoglobin levels
时间窗: 24 hours
The basal hemoglobin levels ( gr/dL) of the patients will be compared with the hemoglobin levels at 2nd, 6th and 24th hours.
Comparison of patients' preoperative and postoperative hematocrit levels
时间窗: 24 hours
The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 2nd, 6th and 24th hours
次要结局
- Comparison of the patients' postoperative systolic and diastolic blood pressure(2 hours)
- Comparison of the patients' postoperative heart rate(2 hours)
研究者
Busra Lekesiz
Clinical Doctor
Ankara Etlik City Hospital