Pregnancy Related Clinical Trial
— MANGOOfficial title:
Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
NCT number | NCT04405700 |
Other study ID # | 2002126816 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 29, 2020 |
Est. completion date | May 31, 2025 |
Verified date | February 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Recruiting |
Enrollment | 2800 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Kenya | Moi Teaching and Referral Hospital | Eldoret |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | At time of delivery | |
Primary | 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) | At 1, 6, and 12 months post-delivery |
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