Immediate Versus Delayed Insertion of the Levonorgestrel-Releasing Intrauterine Device Following Dilation and Evacuation: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.
研究概览
简要总结
This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation & evacuation (D&E) compared to delayed insertion 3-6 weeks post-D&E. Eighty-eight women undergoing D&E between 15 0/7 and 23 6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary outcome is LNG-IUD usage six months following enrollment. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than women receiving delayed insertion. Secondary outcomes include the proportion receiving an IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The utility of ultrasonography in predicting expulsion will also be examined. Anticipated problems include poor subject follow-up and coordinating the intra-operative study procedures.
详细描述
The D&E will be performed in the usual fashion. The uterus will be sounded to the fundus. Once the D&E is complete, the investigator or co-investigator will check the post-enrollment exclusion criteria to ensure that no events during the D&E made the subject ineligible. If the subject remains eligible, the randomization packet will be opened.
Immediately Post-D&E Procedure.
- Group 1: IUD will be placed per study protocol. The strings will be trimmed to be flush with the cervix. Using transabdominal sonography, the distance from the serosal surface of the uterine fundus to the distal tip of the IUD will be measured.
- Group 2: No additional procedures will be performed in the operating room.
Post-Operative Care. The subject will then be taken to the recovery room for routine post-operative care.
- Group 1: A brief questionnaire will be administered. No additional procedures will be performed in the recovery room.
- Group 2: A brief questionnaire will be administered. The subject will be asked to start her previously chosen method of contraception.
- Subjects will be asked to call if any temperature exceeds 38°C (100.4°F). If a subject reports a fever (>38°C), an interim visit will be scheduled as described below.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age from 15 weeks 0 days to 23 weeks 6 days at enrollment (time of D&E), confirmed by ultrasound
- •Has already consented to a D&E
- •Desires to use the LNG-IUD (Mirena) for contraception for 12 months or more
- •Willing and able to sign an informed consent
- •Willing to comply with the study protocol
- •Age greater than or equal to 18 years
- •Primary residency in Allegheny, Beaver, Washington, Westmoreland, Butler, Armstrong, Indiana, Fayette, Greene, or Lawrence counties of Pennsylvania
排除标准
- •Allergy to either polyethylene or levonorgestrel
- •Urgent need for termination of pregnancy (active bleeding or infection)
- •Exposure to or treatment for gonorrhea or Chlamydia within the past 90 days
- •Diagnosis of pelvic inflammatory disease within the past year
- •Presence of one or more leiomyomata greater than 3 centimeters in diameter
- •Uterine anomaly (other than a repaired septate uterus)
- •Current participation in any other intervention trial
- •Post-Enrollment Pre-Randomization Exclusion criteria (to be assessed at the completion of the D&E. These criteria will be used to define a group not eligible for immediate insertion. Since these complications contraindicate immediate insertion, the issue of whether immediate and delayed insertion is preferable is no longer in question.)
- •Uterine perforation
- •Hemorrhage as defined by one of the following: (1) need for transfusion; (2) estimated blood loss greater than 500 cc; (3) intrauterine placement of a Foley catheter; or (4) the use of 3 or more doses of uterotonic medications
- •Evidence of infection at the time of the D&E, including fever (temperature ≥ 38°C) or pus at the cervical os
- •Subject no longer desires a LNG-IUD
研究组 & 干预措施
Arm I
Levonorgestrel IUD will be inserted immediately after completion of D&E
干预措施: Levonorgestrel IUD (Drug)
Arm 2
Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)
干预措施: Levonorgestrel IUD (Drug)
结局指标
主要结局
The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.
时间窗: 6 months
To assess the six-month usage rate of the LNG-IUD when placed immediately after D\&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D\&E. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D\&E procedure than women receiving delayed insertion.
次要结局
- To Examine the Number of Women Receiving the LNG-IUD in Each Group(2 Months)
- To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion(6 months)
研究者
Heather Hohmann
MD
University of Pittsburgh