Oral Contraceptive Pills Versus Expectant Management for Retained Pregnancy Products After a First Trimester Miscarriage: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- persistent retained pregnancy products rate
研究概览
简要总结
We speculate that the use of combined oral contraceptives may be a possible solution to promote the management of retained pregnancy products versus expectant management. By withdrawing the pill, the endometrium is expected to shed in a synchronized fashion (estrogen and progestin withdrawal bleeding and may also shed the retained products of conception and avoid a surgical procedure with its related potential complications.
详细描述
Miscarriage is a common event in general gynaecological practice, and is an age-dependent outcome. It is estimated -that approximately 20 percent of clinically recognized pregnancies will result in a miscarriage, and the prevalence is much higher if preclinical pregnancies are included as well .Failure to pass the contents of the pregnancy is reported in 15% of patients going through a spontaneous 1st trimester miscarriage and a similar rate in patients going through an induced medical abortion after a spontaneous pregnancy loss (miscarriage) and planned pregnancy termination using PGE1 (MisWe speculate that the use of combined oral contraceptives may be a possible solution to promote the management of retained pregnancy products versus expectant management. The exposure to combined oral contraceptives is known to induce secretory and decidual changes in the endometrium .By withdrawing the pill, the endometrium is expected to shed in a synchronized fashion (estrogen and progestin withdrawal bleeding). We hypothesize that such withdrawal bleeding may also shed the retained products of conception and avoid a surgical procedure with its related potential complications. oprostol).
All patients diagnosed with RPOC according to the inclusion and exclusion criteria , will be asked to give their informed consent to take part in the study.
Once informed consent forms are signed, the patient will be randomized (using a randomization table handled by a 3rd party) into one of 2 groups:
- Expectant management of 3 weeks and a follow up visit a week after.
- Oral contraceptive agent, given for free, for 3 weeks and a follow up visit a week after treatment withdrawal.
We wish to emphasize that the current management in our ward is expectant management in the population eligible for this study.
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
- Single (Outcomes Assessor)
盲法说明
Data analysis will be performed according to group code .
入排标准
- 年龄范围
- 16 Years 至 54 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients going through a Misoprostol or Misoprostol/Mifepristone induced procedure after a spontaneous 1st trimester pregnancy loss or as a 1st trimester planned pregnancy termination and present retained pregnancy products by a trans-vaginal ultrasound scan.
- •Patients after a surgical evacuation of pregnancy products (dilatation and curettage - D&C) of a 1st trimester miscarriage and present retained pregnancy products by a trans-vaginal ultrasound scan.
- •All retained products included are of a previously confirmed intra-uterine pregnancies.
- •Asymptomatic patients or mild symptoms of bleeding (spotting).
- •Presence of a measurable hyperechoic material by 2 dimensional TVUS
排除标准
- •Retained products with any of the following clinical presentations : more than a mild vaginal bleeding, hemodynamic instability, signs of infection and/or abdominal pain.
- •Any suspicion of a molar pregnancy.
- •A known contra-indication for the use of oral contraceptives
研究组 & 干预措施
Oral contraceptives
Oral contraceptive agent, given for free, for 3 weeks and a follow up visit a week after treatment withdrawal.
干预措施: Oral contraceptive (Drug)
Expectant management
Expectant management for 3 weeks and a follow up visit a week later.
干预措施: Expectant management (Other)
结局指标
主要结局
persistent retained pregnancy products rate
时间窗: 4 weeks
rate
次要结局
未报告次要终点
研究者
Anat Hershko Klement
Principal Investigator
Meir Medical Center