NCT04405700 Measuring Adverse Pregnancy and Newborn Congenital Outcomes
| NCT ID | NCT04405700 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | HIV/AIDS |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,800 participants |
| Start Date | 2020-09-29 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,800 participants in total. It began in 2020-09-29 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site: Inclusion criteria for women 1. Pregnant and enrolled in ANC at the study site; 2. 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 1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age 2. The infant has a suspected CA on surface exam Exclusion criteria for infants (none)
Frequently Asked Questions
Who can join the NCT04405700 clinical trial?
This trial is open to female participants only, studying HIV/AIDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04405700 currently recruiting?
Yes, NCT04405700 is actively recruiting participants. Visit ClinicalTrials.gov or contact Indiana University to inquire about joining.
Where is the NCT04405700 trial being conducted?
This trial is being conducted at Eldoret, Kenya.
Who is sponsoring the NCT04405700 clinical trial?
NCT04405700 is sponsored by Indiana University. The trial plans to enroll 2,800 participants.
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