Safe Maternity Care Through Immediate Provision of Highly-effective Postpartum Contraception
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 3
- 主要终点
- Proportion of women receiving immediate postpartum long-acting contraception
研究概览
简要总结
This is a multicenter observational study of implementation of postpartum contraceptive counseling and provision into the maternity care setting in Colombia, South America. The primary aim is to determine proportion of uptake of highly-effective contraceptive use after these methods become available immediately postpartum. Secondary aims include rapid repeat pregnancy rates, use of other types of contraception, breastfeeding continuation, and visualization of IUD strings after immediate postpartum placement.
详细描述
This pre- post-intervention study will take place in Colombia, South America in 2 cities: Medellin (2 sites and Cartagena 1 site). The main objective is to determine the proportion of contraceptive usage by women who have just had a baby, before and after the introduction of specialized contraceptive counseling into maternity care and availability of the most effective contraceptive methods:
Group 1 (Standard of care) participants will be asked about intention for contraception usage upon hospital discharge after maternity care.
Group 2 (Intervention) participants will receive standardized contraceptive counseling and immediate access to the method of choice, including long acting reversible contraception (LARC) and other locally available methods. LARC methods available in Colombia include the copper-T intrauterine device (IUD) and Jadelle® implant, both of which are safe for usage in postpartum women.
Both groups will undergo follow- up via phone at 6-8 weeks, and 6 and 12 months postpartum to determine contraceptive continuation, repeat pregnancy, and to track any complications with the usage of LARC, including infection and contraceptive failure. For subjects with an IUD, an additional visit would take place at 8-10 days to determine need for IUD string trimming and visualization of strings.
The intervention will include introduction of specialized standardized contraceptive counseling to occur during inpatient maternity care and immediate postpartum availability of LARC methods. Currently, contraceptive counseling is left to the postpartum primary care setting and obstetric providers are not trained for immediate IUD placement. LARC devices are not typically available in the inpatient setting. Providers and staff of all levels will be trained in standardized contraceptive counseling methods. Obstetric providers will be trained in immediate postplacental IUD insertion. Staff nurses and providers will have access to company-sponsored implant insertion training programs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman in labor
- •Live fetus over 20 weeks gestation
- •Age >14 years
排除标准
- •No medical exclusions for the contraceptive method chosen
结局指标
主要结局
Proportion of women receiving immediate postpartum long-acting contraception
时间窗: Through hospital discharge (an average of 3 days)
The proportion of women who receive immediate long-acting contraception prior to hospital discharge following the intervention phase of training and availability of devices will be compared to a baseline group prior to the implementation.
次要结局
- Continuation of long-acting contraception placed immediately postpartum(6, 12 and 18 months postpartum)
- Complications of contraception(6, 12 and 18 months postpartum)
- Comparison of long-acting methods to short-acting methods(6, 12, and 18 months postpartum)
研究者
Maureen Baldwin
Assistant Professor
Oregon Health and Science University