Effect of the Immediately Postpartum Insertion of the Etonogestrel Releasing Implant on Infant Growth and Development
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- neonatal growth
研究概览
简要总结
This study aims to assess whether there is change in the growth and development of newborns whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48 hours of delivery compared with those with standard implant insertion (6 week postpartum).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who desire to use the ENG implant as a contraceptive method and desire to breastfeed her newborn for ate least 3 months;
- •With no contraindication to breastfeeding, whose newborn is healthy, without malformations, born at term (gestational age ≥ 37 weeks), with appropriate weight for gestational age and with normal sucking ability
排除标准
- •Tobacco smokers, drug addicts or alcoholics;
- •Women with educational levels lower than 5 years;
- •Women with clinical conditions considered category 3 and 4 for implant use by the WHO;
- •Women with histories of psychiatric illness;
- •Women using medications that could alter the concentration of ENG,
- •Women with known allergies to the local anesthetic lidocaine (used to place the implant);
- •Women who wanted to keep their cyclic menstrual bleeding
研究组 & 干预措施
early insertion
Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum. The ENG implant will be inserted subdermally in the non-dominant arm of volunteers upon local anesthesia with 2% lidocaine with vasoconstrictor, according to the manufacturer's instructions.
干预措施: early insertion (Drug)
conventional insertion
Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted after 6 week of the delivery. The ENG implant will be inserted subdermally in the non-dominant arm of volunteers upon local anesthesia with 2% lidocaine with vasoconstrictor, according to the manufacturer's instructions.
干预措施: conventional insertion (Drug)
结局指标
主要结局
neonatal growth
时间窗: 12 months
次要结局
- child development(12 months)
研究者
Carolina Sales Vieira
MD, PhD
University of Sao Paulo