Measuring Adverse Pregnancy and Newborn Congenital Outcomes

NCT04405700 | Recruiting

• 1 other identifier: 2002126816
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV/AIDS; Pregnancy Related; Congenital Disorders; Newborn Morbidity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Cohort 1 (C1)

Prospective recruitment of pregnant women enrolling in antenatal clinic (ANC) at the site. All HIV+ pregnant women and a 1:1 systematic sample of HIV- pregnant women enrolling in ANC at the site will be prospectively enrolled. In addition, medical record data for the mother and infant will be collected at the time of delivery for all women who deliver at the site and as such will contribute to a subset of C2 (below). Women enrolled in C1 who do not deliver at the site will be contacted by phone and through field follow-up to ascertain their pregnancy and infant outcomes. Infants born to women enrolled in this component who are suspected of having congenital abnormalities (CAs) will be enrolled as outlined in C3 (below) if their mothers deliver at the site. If their mothers do not deliver at the site these infants will be enrolled in the field. Photos/videos of infants with CAs will also be taken for review and classification by a panel of experts (see C3 below).

Other: Pharmacovigilance surveillance program

Cohort 2 (C2)

Cross-sectional data collection for deliveries at the site. Data will be collected retrospectively from medical records for all women who deliver at the site (including the women enrolled in C1 above), as well from the medical records of all newborn infants and stillbirths delivered at the site. Missing or incomplete information in the woman or her infant's medical record will be clarified by contacting the woman to provide this information.

Other: Pharmacovigilance surveillance program

Cohort 3 (C3)

Photos/videos of infants with CAs. All newborn infants and stillbirths ≥ 24 weeks gestational age delivered at the site, as well as all infants born to women enrolled in C1, will be assessed by surface exam for the presence of CAs. Video and photographs will be taken of CAs identified on surface exam. These images will be reviewed and classified by panel of experts in genetics, dysmorphology and teratology. Mothers of infants with major CAs will be contacted by phone at 1, 6, and 12 months post-delivery to ascertain their infants' vital status and care engagement status.

Other: Pharmacovigilance surveillance program

Interventions

Pharmacovigilance surveillance program OTHER

The 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).

Cohort 1 (C1); Cohort 2 (C2); Cohort 3 (C3)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant and postpartum women who are HIV+ and HIV- and their infants.

You may qualify if:

• Pregnant and enrolled in ANC at the study site;
• Understands English or Swahili.

You may not qualify if:

• C2. Data collection for all deliveries at the site:
• a. Infant is delivered at the site and results in the infant/stillbirth being registered at the site
• C3. Photos/videos of infants with CAs:
• The infant is live or stillborn at ≥ 24 weeks estimated gestational age
• The infant has a suspected CA on surface exam

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, 30100, Kenya

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: September 29, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)