Progestin-Only Pill Use and Breastfeeding Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
研究概览
简要总结
This study will assess the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills (POPs) on maternal, breastmilk, and infant outcomes.
详细描述
This is a placebo-controlled randomized controlled trial enrolling dyads of birthing people and their newborn infants. We will explore if the type and timing of initiation of pills is acceptable to the user with minimal side effects, impacts the supply or composition of breastmilk, and/or affects infant growth.
Birthing people will be randomly assigned to 1 of 3 groups and will be blinded to group assignment:
- immediate initiation of drospirenone-containing progestin-only pills (d-POPs),
- immediate initiation of norethindrone-containing progestin-only pills (n-POPs)
- immediate initiation of a placebo pill for one month followed by d-POPs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age and older
- •Desires to use POPs for 3 months
- •Speak English or Spanish
- •Had a vaginal or cesarean delivery of a singleton full term (≥37 weeks) infant less than 168 hours prior
- •Intends to breastfeed exclusively for 6 months
排除标准
- •Desire another pregnancy in less than 6 months
- •Do not intend to exclusively breastfeed
- •Do not have access to a telephone
- •Have any medical contraindication to POPs
- •Have any contraindication to breastfeeding, including maternal illegal drug use, history of augmentation or reduction, infant with major congenital anomaly
- •Cognitively impaired
- •Currently incarcerated
研究组 & 干预措施
Early Initiation d-POPs
Initiation of d-POPs 120-160 hours after delivery. Dosing is 4mg daily for 24 days followed by 4 daily inactive tablets for 2 months.
干预措施: Progestin Only Contraceptive Pills (Drug)
Early Initiation n-POPs
Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months.
干预措施: Progestin Only Contraceptive Pills (Drug)
Interval Initiation of d-POPs
Placebo starting 120-160 hours after delivery, continuing for 28 days. Followed by 24 days of 4mg daily of d-POPs and 4 daily inactive tablets.
干预措施: Progestin Only Contraceptive Pills (Drug)
结局指标
主要结局
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
时间窗: 8 weeks postpartum
Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.
次要结局
- Satisfaction With Assigned POP(8 weeks postpartum)
- Protein Content of Human Milk(4 weeks postpartum)
- Fat Content of Human Milk(4 weeks postpartum)
- Change in Infant Height(Baseline and 4 weeks after delivery)
- Carbohydrate Content of Human Milk(4 weeks postpartum)
- Perception of Milk Supply(8 weeks postpartum)
- Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum(8 weeks postpartum)
- Vaginal Bleeding(8 weeks postpartum)
- Change in Infant Head Circumference(Baseline and 4 weeks after delivery)
- Change in Infant Weight(Baseline and 4 weeks after delivery)
研究者
Sarah Averbach, MD MAS
Associate Professor
University of California, San Diego