Intraumbilical Oxytocin Compared to Placental Cord Drainage in the Management of Third Stage of Labor: A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Duration of the third stage of labor.
研究概览
简要总结
The aim of this study is to compare the effectiveness of intraumbilical oxytocin and placental cord drainage in the management of third stage of labor.
Does the use of intraumbilical vein oxytocin injection or the use of Placental cord drainage can cause a reduction of blood loss, Hb level drop, the length of the third stage of labor and the incidence of manual removal of the retained placenta during the third stage of labor in pregnant women after delivery of the infant?
详细描述
Study:
Study Design: A prospective randomized clinical trial. Study setting: The study will be conducted in Ain Shams University Maternity Hospital.
All pregnant women in the delivery ward will be submitted to:
- Detailed complete history taking with special emphasis to maternal age, Parity, Maternal weight, as well as presence of any disease.
- Clinical Examination:
a. General examination. b. Abdominal examination (Symphysis-fundal height) and pelvic examination. 3. Investigation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Randomization will be based on the sequence generation created by computer and the randomization tables will be kept with the study supervisor. Consenting patients fulfilling inclusion criteria will be randomized into one of the following 3 groups. Randomized allocation will be kept in opaque sealed envelopes, with enrollment numbers written on the envelopes. The envelopes will contain a card on with the designated study group will be written. After enrollment of the patients in the study, the envelopes marked with study number will be unsealed and the patients allocated to either groups
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
- •Pregnant women between 18-35 years of age with normal pregnancy.
- •A singleton fetus at a gestational age of 37 - 42 weeks in a cephalic presentation.
- •Neonatal birth weight of 2500 to 4500 grams.
排除标准
- •Medical disorders and hypertensive disorders of pregnancy.
- •Intrauterine fetal death.
- •Known or suspected fetal anomalies.
- •Oxytocin induction or augmented cases.
- •Obstetrical complications (bleeding, premature rupture of membranes).
- •Previous CS or Previous Myomectomy.
研究组 & 干预措施
• Group (A) "Study Group 1":
In the labor room women in Group A (n = 50):
- Clamping and cutting the placental cord after delivery of the baby.
- Immediate intraumbilical vein injection of Oxytocin (Syntocinon®) 20 units diluted in 20 ml of 0.9% saline solution
干预措施: Intraumbilical vein injection oxytocin (Drug)
• Group (B) "Study Group 2":
In the labor room women in Group B (n = 50):
- Clamping and cutting the placental cord after delivery of the baby.
- Immediate unclamping of the maternal side, allowing the blood to drain freely for a duration of three minutes.
干预措施: placental cord drainage (Procedure)
• Group (C) "Control Group":
In the labor room women in Group C (n = 50):
- Clamping and cutting the placental cord after 2 minutes of delivery of the baby.
- Placenta will be delivered spontaneously after appearance of clinical signs of placental separation
干预措施: Expectant managment of 3rd stage of labour (Procedure)
结局指标
主要结局
Duration of the third stage of labor.
时间窗: 5-15 minutes
Duration of placental expulsion from the uterus after delivery of the fetus. by the use of a stop watch to calculate the time in minutes and seconds passing starting from the delivery of the baby till delivery of the placenta outside the the vagina. To compare How long does the 3rd stage of labor persist with each intervention (in minutes and seconds).
次要结局
- Retained placenta(>30 minutes)
- the Need for manual removal of placenta(> 30 minutes)
- the drop in hemoglobin in gm/dl(after 2 hours)
研究者
Eslam Mohammed Abbas
physician
Ain Shams University