Oxytocin Effectiveness in First Trimester Dilatation and Curettage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Perioperative Blood Loss Assessment
研究概览
简要总结
The aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the D&C procedure, as well as to assess early and late complications associated with it's use.
详细描述
Study Design
This study is a prospective randomized placebo-controlled double-blind trial. Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.
Group 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
The medication bags will be prepared by the Assuta Ashdod University Hospital Pharmacy, coded with serial numbers, and randomized using computerized software. Both the investigators and patients will remain unaware of the composition of the distension medium to ensure blinding.
A total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below. Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
randomization will be done by hospitals pharmacy. A total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below. Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.
- •Patients aged 18 years and older who are capable to provide informed consent.
排除标准
- •individual intolerance to oxytocin
- •mullerian anomalies
- •Fibroid uterus
- •thrombophilia or coagulation disorders
- •cardiovascular disease
研究组 & 干预措施
Placebo
Participants will receive 100 ml of saline alone.
干预措施: Sodium Chloride 0.9% Inj (Drug)
Oxytocin
Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
干预措施: Oxytocin (Drug)
Oxytocin
Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.
干预措施: Sodium Chloride 0.9% Inj (Drug)
结局指标
主要结局
Perioperative Blood Loss Assessment
时间窗: 14 days
We will assess perioperative blood loss by: * Measuring the content collected in the vacuum apparatus after the procedure. * Recording hemoglobin and hematocrit levels prior to the procedure. * Measuring hemoglobin and hematocrit levels immediately after the procedure. * Monitoring hemoglobin and hematocrit levels two weeks post-procedure.
次要结局
- perioperative complications according to the Dindo-Clavien scale(30 days)