Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting · NCT04405700 · Observational (researchers observe without assigning treatment) · Lead sponsor: Indiana University
View the official record on ClinicalTrials.gov →Interventions studied
Pharmacovigilance surveillance program
What this trial is about
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).
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- for women
- Pregnant and enrolled in ANC at the study site;
- Understands English or Swahili.
Exclusion criteria
- for women a. Any physical or mental disability that prevents the woman from providing informed consent
- Inclusion criteria for infants
- a. All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none)
- C2. Data collection for all deliveries at the site:
- Inclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site
- Exclusion criteria for women (none)
- Inclusion criteria for live/stillborn infants
- a. Infant is delivered at the site and results in the infant/stillbirth being registered at the site
- Exclusion criteria for infants (none)
- C3. Photos/videos of infants with CAs:
- Inclusion criteria for infants
- The infant is live or stillborn at ≥ 24 weeks estimated gestational age
- The infant has a suspected CA on surface exam
- Exclusion criteria for infants (none)
Where it is running
1 location listed.
- Moi Teaching and Referral Hospital - Eldoret, Kenya