Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Continuation at 1 Year
研究概览
简要总结
This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.
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
- None
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adolescents ages 14-24 attending prenatal care
- •Greater than 20 weeks estimated gestational age
- •English or Spanish-speaking
- •Desire to use the contraceptive implant for contraception postpartum
- •Anticipated delivery of a healthy infant vaginally or by cesarean.
排除标准
- •Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including
- •current or past history of thrombosis or thromboembolic disorders
- •hepatic tumors (benign or malignant)
- •active liver disease
- •undiagnosed abnormal genital bleeding
- •known or suspected carcinoma of the breast (or a personal history of breast cancer)
- •hypersensitivity to any of the components of the contraceptive implant.
- •Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate
- •Characteristics that would preclude involvement after delivery:
- •Birth of a stillborn infant.
- •Maternal ICU admission after delivery
- •Maternal postpartum hemorrhage requiring blood transfusion
- •Prolonged hospital stay (>7 days) postpartum
- •Coagulopathy associated with the pregnancy
- •Severe pregnancy-induced hypertension
- •Fever >38 degrees C postpartum
- •Adolescent women who are not competent to consent, secondary to stress from the labor process, for example severe pain or sleep deprivation, will not be offered enrolment into the trial
研究组 & 干预措施
6 week postpartum contraceptive implant
randomized to receive contraceptive implant at normal 6 week postpartum visit
干预措施: Contraceptive implant (Drug)
Immediate postpartum contraceptive implant
randomized to receive contraceptive implant prior to leaving the hospital postpartum
干预措施: Contraceptive implant (Drug)
结局指标
主要结局
Continuation at 1 Year
时间窗: 12-14 months
The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.
次要结局
- Satisfaction(12 months)
- Rapid Repeat Pregnancy(12 months)
研究者
Amy Bryant
Assistant Professor
University of North Carolina, Chapel Hill