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Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Study acronym: MANGO
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 years later May 31, 2026 → May 31, 2031
See other at-risk trials from Indiana University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from May 31, 2026 to May 31, 2031v6
  2. Primary and study completion dates: May 31, 2025 to May 31, 2026v5
  3. Re-verified, no change to tracked fieldsv4
  4. Enrollment target: 1600 to 2800
    • Study sites: 2 to 1
    • Primary completion date: Jun 1, 2025 to May 31, 2025
    • Study completion date: Jun 1, 2026 to May 31, 2025
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 4700 to 1600
    • Primary completion date: Jun 2022 to Jun 1, 2025
    • Study sites: 1 to 2
    • Study completion date: Jun 2022 to Jun 1, 2026
    • Start date changed from estimate of Jul 2020 to Sep 29, 2020
    • Study description expanded, about 5 words
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04405700
Lead Sponsor Indiana University
Conditions
(from sponsor)		 HIV/AIDS, Pregnancy Related, Congenital Disorders, Newborn Morbidity
Related terms Acquired Immunodeficiency Syndrome, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Enrollment 2,800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov