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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
St. Joseph's Hospital
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Maple Leaf Medical Clinic
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Total enrollment / eligible population per year
Qualitative information on the reasons to decline participation will be collected and summarized. Reasons for non-enrolling questionnaire will be used.
Time frame: 12 months
Safety of progesterone supplementation during pregnancy for HIV-positive women.
The number of Grade 3 or 4 AE in the ITT vs. comparator group. The number of Grade 1 or 2 AE in the ITT vs. comparator group. AE questionnaire.
Time frame: 40 weeks
Acceptability of progesterone supplementation during pregnancy for HIV+ women.
Assessed in the ITT group. Acceptability based on experience with medication questionnaire. Screening questionnaire (acceptability of being recruited to no treatment arm)
Time frame: 40 weeks
Compliance of progesterone supplementation. Assessed in the ITT group.
Number of missed doses / total prescribed doses per patient. Compliance questionnaire
Time frame: 40 weeks
Barriers to adherence to progesterone supplementation. Assessed in the ITT group
Reasons for missed dose questionnaire. Reasons for missed appointment questionnaire
Time frame: 40 weeks
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