Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorIndiana University
About this trial
The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant and enrolled in ANC at the study site;
Understands English or Swahili.
Disqualifiers
The infant is live or stillborn at ≥ 24 weeks estimated gestational age
The infant has a suspected CA on surface exam
Trial population
Pregnant and postpartum women who are HIV+ and HIV- and their infants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pharmacovigilance surveillance program
Other interventionThe pharmacovigilance (PV) surveillance program will prospectively monitor for adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).
Treatment groups
2,800 Participants
are divided into 3 treatment groupsGroup A: Cohort 1 (C1)1 intervention
Group B: Cohort 2 (C2)1 intervention
Group C: Cohort 3 (C3)1 intervention
Trial outcomes
Primary outcomes
1
Pregnancy outcomes
Live Birth, Still Birth, Miscarriage, Termination of pregnancy, Ectopic Pregnancy, Molar Pregnancy, Not Pregnant, Other); also including pre-term delivery (\<37 weeks gestational age) or very pre-term delivery (\<32 weeks gestational age)
Time frame
At time of delivery2
Infant/birth outcomes
Congenital abnormalities on newborn surface exam (e.g., extra digit, hydrocephalus, skull defects, eyes, face, mouth/lip/palate, chest, abdomen, anus, limbs, spine (including neural tube defects), hips, genitalia, skin, etc.); also including low birth weight, small for gestational age (\<10th percentile) or very small for gestational age (\<3rd percentile)
Time frame
At 1, 6, and 12 months post-deliverySponsors and contacts
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Source ClinicalTrials.gov