Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 6 month IUD usage rates
研究概览
简要总结
The purpose of this study is to determine, in a pilot setting, if this study is feasible in terms of recruitment, willingness to be randomized, provision of contraceptive methods, and follow-up. The investigators hypothesize that this pilot study will be feasible in terms of recruitment, provision of care, and follow-up.
The study will be a pilot randomized controlled trial comparing outcomes of immediate post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be powered to detect a difference, but rather the investigators will enroll all eligible and interested women during the three-month enrollment period. Potential participants who do not choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pregnant at time of enrollment
- •Scheduled to undergo non-emergent cesarean delivery
- •Will have to wait at least 8 hours before their cesarean section
- •Are not in active labor
- •Desires to use the Copper T 380A for contraception
- •Willing and able to sign an informed consent
- •Willing to comply with the study protocol
- •Age greater than or equal to 18 years
- •English or Luganda speaking
- •Willing to be accompanied home upon discharge from the hospital and have their address recorded in order to be able to visit them at home at 6 months postpartum if they do not return for their 6 month follow-up visit.
排除标准
- •Allergy to copper or pelvic tuberculosis, severe thrombocytopenia
- •Positive N. gonorrheae or C. trachomatis testing
- •Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the Copper T 380A
- •Uterine anomaly which would not allow placement of the Copper T 380A
- •Current cervical cancer or carcinoma in-situ
- •Desire for repeat pregnancy in less than 12 months
- •Evidence of intra-uterine infection (Chorioamnionitis)
- •Pre-term birth prior to 34 weeks of gestation
- •Diagnosis of AIDS (HIV is not an exclusion criteria)
- •Fetal demise
- •Antepartum hemorrhage
- •Ruptured uterus
- •Evidence of severe anemia
- •Post enrollment exclusion criteria
- •Group 1: Interval development of any of the above exclusion criteria (New evidence of chorioamnionitis; fetal demise; ruptured uterus; eclampsia; severe anemia)
- •Group 1: Post-partum hemorrhage with continued active bleeding that does not allow placement of the Copper T 380A within 10 minutes of the delivery of the placenta
- •Group 1: Prolonged rupture of membranes > 12 hours
- •Group 2: Diagnosis of active cervical infection within 3 months of planned insertion, or evidence of active pelvic or cervical infection, pus at the cervical os or any concern for upper genital tract infection, including fever (temperature ≥ 38° C) or uterine or adnexal tenderness. Diagnosis of new pregnancy.
- •Group 2: Interval development of any of the above exclusion criteria (i.e. new suspicion of cervical cancer or carcinoma in situ)
- •Both Groups: Participant no longer desires a Copper T 380A
结局指标
主要结局
6 month IUD usage rates
时间窗: 6 months
The number of participants enrolled who are using the Copper T 380A at 6 months post-delivery. This will include participants who are excluded at time of delivery or interval insertion and participants who do not follow up for interval Copper T 380A insertion
次要结局
- IUD Expulsion(within 6 months)
- IUD Removal(within six months)
- IUD insertion(within 6 months)
- Pregnancy(within 6 months)
- Infection(within 6 months)
- Uterine Perforation(within 6 months)