跳至主要内容
临床试验/NCT03657602
NCT03657602已完成早期 1 期

Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年12月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
28
试验地点
1
主要终点
Expulsion of intrauterine contraception

研究概览

简要总结

In this randomized trial, investigators intend to determine the expulsion and discontinuation rate of immediate postpartum intrauterine devices in the patient population of the University of Oklahoma Women's Healthcare Specialists Clinic (OUWHSC).

详细描述

Between 40-57% of women report having unprotected intercourse prior to the 6 week postpartum visit. Immediate postpartum long-acting reversible contraception (LARC) is extremely important in preventing short-interval and unintended pregnancies. The postpartum period is an excellent time for intrauterine device (IUD) or implant insertion as women are often highly motivated to prevent unwanted pregnancies at this time. Per the American College of Obstetrics and Gynecology (ACOG), expulsion rates for immediate postpartum IUD insertion are higher than for interval or post-abortion insertion. Despite the higher expulsion rate of immediate postpartum IUD placement over interval placement, cost-benefit analysis data strongly suggest the superiority of immediate placement in reduction of unintended pregnancy, especially for women at greatest risk of not attending the postpartum follow-up visit. This study will randomly allocate participants one to one to the Kyleena or the Mirena IUD group, and participants will be blinded to allocation of groups. Participants will follow up at routine postpartum visit within 4 weeks of delivery, and a second follow up will be performed at 10 weeks. Ultimately, this study will attempt to provide more detailed information on the difference of rates of expulsion and discontinuation of the different-sized Mirena and Kyleena intrauterine devices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participant will be blinded to group assignment

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years or older
  • desire an intrauterine device as postpartum contraception
  • want to avoid pregnancy for at least 1 year
  • are currently pregnant
  • desire immediate postpartum IUD insertion.

排除标准

  • known uterine or cervical anomaly
  • untreated cervical infection
  • untreated cervical infection
  • pelvic infection within 3 months of the study
  • recent (within last 3 months) or active intrauterine infection
  • genital bleeding of unknown etiology
  • history of postpartum or postabortal sepsis
  • cervical cancer or carcinoma in suit
  • plan to leave Tulsa area within 10 weeks postpartum
  • allergy to device ingredients

研究组 & 干预措施

Contraceptive Kyleena

Experimental

Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Kyleena Intrauterine System

干预措施: Kyleena Intrauterine System (Drug)

Contraceptive Mirena

Experimental

Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Mirena Intrauterine System

干预措施: Mirena Intrauterine System (Drug)

结局指标

主要结局

Expulsion of intrauterine contraception

时间窗: within 10 weeks of placement

IUD string check and ultrasound check

次要结局

  • Discontinuation of intrauterine contraception(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验