NCT03297216已完成3 期
Z 31702 - Improving Pregnancy Outcomes With Progesterone (IPOP): a Trial of 17-Hydroxyprogesterone Caproate to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing Preterm Births or Stillbirths
研究概览
简要总结
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
详细描述
Weekly intramuscular injections of 250mg 17-alpha hydroxyprogesterone caproate (17P) or indistinguishable placebo will be randomly allocated in a 1:1 ratio started between 16-24 weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner.
Individual participants will be followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •less than 24 0/7 weeks of gestation
- •viable intrauterine singleton pregnancy confirmed by ultrasound
- •antibody-confirmed HIV-1 infection
- •currently receiving antiretroviral l therapy (ART) or intending to commence ART in pregnancy
- •ability and willingness to provide written informed consent
- •intent to remain in current geographical area of residence for the duration of study
- •willing to adhere to weekly study visit schedule
排除标准
- •confirmed prior spontaneous preterm birth
- •multiple gestation
- •known uterine anomaly
- •planned or in situ cervical cerclage
- •major fetal anomaly detected on screening ultrasound
- •indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean)
- •threatened abortion, preterm labor, or ruptured membranes at time of enrollment
- •known allergy or medical comorbidity listed as a contraindication to 17P in the prescribing information
- •prior participation in the trial
- •any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.
研究组 & 干预措施
250 mg 17P
Active Comparator
weekly intramuscular injection of 250mg 17P
干预措施: 17P (Drug)
Placebo
Placebo Comparator
weekly intramuscular injection of indistinguishable placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants Experiencing Preterm Births or Stillbirths
时间窗: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths
A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age
次要结局
- Number of Participants Experiencing Spontaneous Delivery <28 Weeks(At delivery, up to 28 weeks of gestation)
- Number of Neonatal Deaths(Birth through 28 days postpartum)
- Number of Participants Experiencing Spontaneous Delivery <34 Weeks(At delivery, up to 34 weeks of gestation)
- Number of Participants Experiencing Preterm Birth <34 Weeks(At delivery, up to 34 weeks of gestation)
- Number of Infants With Birth Weight <3rd Percentile for Gestational Age(Birth)
- Number of Infants Who Experienced Maternal-to-Child HIV Transmission(At 6 weeks of life)
- Number of Participants Experiencing Spontaneous Delivery <37 Weeks(At delivery, up to 37 weeks of gestation)
- Number of Infants With 1-minute Apgar Score <7(1 minute of life)
- Number of Participants Experiencing Preterm Birth <37 Weeks(At delivery, up to 37 weeks of gestation)
- Number of Participants Experiencing Preterm Birth <28 Weeks(At delivery, up to 28 weeks of gestation)
- Number of Participants Experiencing Stillbirth(At delivery, up to approximately 40 weeks of gestation)
- Number of Infants With Birth Weight <10th Percentile for Gestational Age(Birth)
- Number of Infants With 5-minute Apgar Score <7(5 minutes of life)
研究者
研究点 (2)
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