Progesterone Supplementation for HIV-positive Pregnant Women on Anti-Retrovirals
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Total enrollment / eligible population per year
研究概览
简要总结
In pregnancy, cART is considered optimal for maternal health and for preventing the emergence of resistance that could compromise further care. In Canada, the majority of HIV-positive pregnant women receive a PI-based cART regimen. In the past, therapy was generally deferred until after the first trimester (if not required for maternal health) to minimize any unknown risk of teratogenicity. However, as treatment is now started earlier in HIV infection and as perinatal transmission rates are lowest in those with prolonged suppression of viral load during pregnancy, women are increasingly commencing cART either before conception or earlier in pregnancy.
Multiple reports and cohort studies provided data suggesting an association between PI-based cART use and preterm birth, low birth weight, and small for gestational age (SGA) babies, although conflicting data exist.
In the general population progesterone supplementation is widely used, is well tolerated, is considered safe, and is beneficial to prevent recurrent pre-term birth and increase birth weight. The investigators experimental findings suggest that PI use during pregnancy is associated with declines in progesterone levels that correlate with fetal growth, and that progesterone supplementation can improve PI-induced fetal growth restriction. The investigators preliminary findings in HIV+ pregnant women suggest that PI-use is associated with declines in progesterone levels, which correlate with birth weight percentile. Since HIV-positive women have higher rates of pre-term delivery and low birth weight that may be magnified by the use of PIs, then progesterone supplementation could be of benefit to neonatal health in the context of HIV-positive pregnancy.
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
- Single (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
- 否
入选标准
- •Documented HIV-1 infection
- •On (stable) or initiating a cART regimen containing either ritonavir-boosted lopinavir (LPV/r), atazanavir (ATZ/r) or darunavir (DRV/r)
- •Pregnant up to 24 weeks gestational age
- •Singleton pregnancy
- •18 years or older
- •Ability to give informed consent
排除标准
- •Hypersensitivity or allergy to soya or peanut (non-active ingredient supplement in Prometrium)
- •Contraindications to intravaginal progesterone use including:
- •documented hypersensitivity to Prometrium
- •active or history of breast cancer,
- •active or history of arterial thromboembolitic disease (e.g. stroke, myocardial infarction, coronary heart disease)
- •active or history of venous thromboembolism (e.g. deep venous thrombosis or pulmonary embolism) or active thrombophlebitis
- •any prior neoplasia, except for skin
- •abnormal vaginal bleeding
- •Known lethal fetal anomaly
- •Any contraindication to continuation of pregnancy
- •Inability to communicate in English
- •Prior participation in this trial
研究组 & 干预措施
Prometrium
Prometrium (progesterone capsules) intervention
干预措施: Prometrium (Drug)
结局指标
主要结局
Total enrollment / eligible population per year
时间窗: 12 months
Qualitative information on the reasons to decline participation will be collected and summarized. Reasons for non-enrolling questionnaire will be used.
次要结局
- Safety of progesterone supplementation during pregnancy for HIV-positive women.(40 weeks)
- Acceptability of progesterone supplementation during pregnancy for HIV+ women.(40 weeks)
- Compliance of progesterone supplementation. Assessed in the ITT group.(40 weeks)
- Barriers to adherence to progesterone supplementation. Assessed in the ITT group(40 weeks)
