Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 主要终点
- Number of Participants Who Continued to Breastfeed at 6 Months
研究概览
简要总结
Objectives
To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:
- To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
- To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills.
- To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
Hypothesis
Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •able to give informed consent
- •postpartum women delivering at the University of New Mexico Hospital
- •Intend to breastfeed
- •Plan to use oral contraceptives as her family planning method
- •Willing to be randomized to either progestin-only pills or combined pills
排除标准
- •medical contraindications to combined pills including history of thromboembolism, uncontrolled hypertension or complex migraine headaches
- •preterm birth (<37 weeks)
- •small for gestational age infant (<2500 grams)
- •large for gestational age infant (>4500 grams)
- •infant with major congenital anomaly
研究组 & 干预措施
Study Arm A
Study Arm A is one of two interventions (Combined estrogen-progestin pill)
干预措施: Combined estrogen-progestin pill (Drug)
Study Arm B
Study Arm B is one of two interventions (Progestin-only pill)
干预措施: Progestin-only pill (Drug)
结局指标
主要结局
Number of Participants Who Continued to Breastfeed at 6 Months
时间窗: Baseline to Week 8, Week 8, 2-6 months
Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery
次要结局
- Infant Occipitofrontal Circumference Growth From 2-8 Weeks(Week 2 and Week 8)
- Number of Participants Who Continued Birth Control Method After 6 Months(Baseline to Week 8, Week 8, 2-6 months)
- Infant Length Growth From 2-8 Weeks(Week 2 and Week 8)
- Infant Weight Growth From 2-8 Weeks(Week 2 and Week 8)
研究者
Eve Espey
Professor, OB-GYN
University of New Mexico