RCT of LNG-IUD vs. DMPA for young postpartum women

年轻产后女性 LNG-IUD 与 DMPA 的随机对照试验

• 批准号: 6807537
• 负责人: NANCY L STANWOOD
• 金额: $ 7.8万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6807537
• 关键词: adolescence (12-20); clinical trials; drug adverse effect; family planning; female; female antifertility drug; human subject; human therapy evaluation; levonorgestrel; medical complication; medical outreach /case finding; medroxyprogesterone; menstrual cycle; nondrug contraceptive; patient oriented research; postpartum; pregnancy; satisfaction; therapy adverse effect; therapy compliance; women' s health; young adult human (21-34)

DESCRIPTION (provided by applicant): The U.S. has the highest unintended pregnancy rate of any developed country, mostly in teens and women in their early twenties due to ineffective contraceptive use. Once a young woman has given birth, helping her choose an effective method of postpartum contraception is crucial to preventing an unintended pregnancy. The injectable depomedroxyprogesterone acetate (DMPA) is a highly effective method of contraception, with better compliance and lower pregnancy rates than oral contraceptives. It is commonly recommended to young women for postpartum contraception. However, up to 50% of women stop using it in the first year due to the side effects of irregular bleeding and perceived weight gain. Clinicians also have concerns that DMPA may worsen depression and inhibit maximum bone density in young women. The levonorgestrel intrauterine device (LNG-IUD) is a very effective, well-tolerated contraceptive. It has not been traditionally considered in this population due to a false perception that IUDs lead to a long-term increased risk of pelvic inflammatory disease (PID). Modern evidence counters these fears, suggesting that LNG-IUD may actually decrease the risk of PID. Its performance as a postpartum contraceptive for young women merits evaluation. We aim to perform a pilot randomized trial of 30 women aged 14 to 25 years comparing postpartum DMPA and LNG-IUD with regard to method continuation and side effects. We also aim to assess the recruitment of postpartum young women for randomization between DMPA and LNG-IUD, measuring the number needed to screen to enroll and randomize one subject. We will recruit subjects during the third trimester of prenatal care and will follow them for one year postpartum for the outcomes of method continuation, unintended pregnancy rate, menstrual complaints, patient satisfaction, complications and side effects. The best postpartum method of contraception is one that works well and that women continue to use. The LNG-IUD is highly effective and has high patient satisfaction and continuation rates in older women. Whether younger women find it satisfactory for postpartum contraception and continue to use it is unknown. If this pilot is successful, we plan to perform a larger trial powered to detect a difference in continuation rates between DMPA and LNG-IUD. Such a study could provide evidence for the safe and effective use of LNG-IUD in young postpartum women, leading to fewer unintended pregnancies.

描述（由申请人提供）：美国在任何发达国家中的怀孕率最高，主要是由于避孕药的无效使用而在二十多岁的青少年和妇女中。一旦一个年轻女子分娩，帮助她选择一种有效的产后避孕方法对于防止意外怀孕至关重要。可注射的乙酸苯甲酸酯（DMPA）是一种非常有效的避孕方法，比口服避孕药更合规性和更低的妊娠率。通常建议年轻女性进行产后避孕。但是，由于不规则出血和感知体重增加的副作用，多达50％的妇女在第一年停止使用它。临床医生还担心DMPA可能会恶化抑郁症并抑制年轻女性的最大骨密度。左甲虫内装置（LNG-IUD）是一种非常有效，耐受性良好的避孕药。 传统上，由于宫内宫内宫内宫内非彩会导致骨盆炎性疾病（PID）的长期风险增加，因此在该人群中一直没有考虑。现代证据反驳了这些恐惧，表明LNG-IUD实际上可能降低了PID的风险。它作为对年轻女性的产后避孕药的表现值得评估。我们的目标是对30名14至25岁的女性进行试验随机试验，比较产后DMPA和LNG-IUD，以进行方法持续和副作用。我们还旨在评估产后年轻妇女在DMPA和LNG-IUD之间随机分组的招募，以测量筛选筛选和随机分配一个受试者所需的数量。我们将在产前护理的三个月期间招募受试者，并将跟随他们产后一年，以获取方法延续的结果，意外怀孕率，月经投诉，患者满意度，并发症和副作用。最好的产后避孕方法是一种效果很好，女性继续使用。 LNG-IUD非常有效，患者的满意度和延续率很高。年轻女性是否发现产后避孕并继续使用它是尚不清楚的。如果该飞行员成功，我们计划进行更大的试验，以检测DMPA和LNG-IUD之间的持续率差异。这样的研究可以提供证据证明在产后妇女中安全有效地使用LNG-IUD，从而减少意外怀孕。