HIV/AIDSMANGONCT04405700
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
An observational study of HIV/AIDS and Pregnancy Related, run by Indiana University at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Pregnancy Related, Congenital Disorders
- What is being tested?
- Pharmacovigilance surveillance program
- How many people
- 2,800 participants
- Where
- 1 siteKenya
- Study dates
- 29 Sep 2020to 31 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant and postpartum women who are HIV+ and HIV- and their infants.
Who may be able to join
- 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
- 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
Show all 9Show fewer
- Infant is delivered at the site and results in the infant/stillbirth being registered at the site
- The infant is live or stillborn at ≥ 24 weeks estimated gestational age
- The infant has a suspected CA on surface exam
Who cannot join
- C3. Photos/videos of infants with CAs:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Moi Teaching and Referral Hospital
Eldoret, 30100
Edwin O Were, MBChB, MMed, +254722288653, eowere@gmail.com
About this study
Official title: Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
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).
Read the detailed description
In part 1 of this study, the investigators will use a mixed prospective and cross-sectional cohort study design to implement a PV program at two health facilities affiliated with the Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators will analyze these data to examine any associations between antiretroviral treatment (ART) and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create standardized protocols and data exchange standards within IeDEA to enable the merging and analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and archiving data from the study in Kenya as well as data collected through a similar, ongoing study at health facilities in South Africa affiliated with IeDEA. This study will establish a multiregional PV infrastructure within IeDEA that can be further scaled within the broader IeDEA network.
- Conditions
- HIV/AIDS, Pregnancy Related, Congenital Disorders, Newborn Morbidity
- Being tested
- Pharmacovigilance surveillance program
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacovigilance surveillance programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Other: Pharmacovigilance surveillance program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: At 1, 6, and 12 months post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start29 Sep 2020
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Moore Humphrey, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405700
- Sponsor's protocol ID
- 2002126816
- Acronym
- MANGO
- Status last verified
- Aug 2026
- First submitted
- 22 May 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
- ClinicalTrials.gov ID
- NCT04405700
- Acronym / sponsor ID
- MANGO / 2002126816
- Conditions
- HIV/AIDS, Pregnancy Related, Congenital Disorders, Newborn Morbidity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
In part 1 of this study, the investigators will use a mixed prospective and cross-sectional cohort study design to implement a PV program at two health facilities affiliated with the Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators will analyze these data to examine any associations between antiretroviral treatment (ART) and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create standardized protocols and data exchange standards within IeDEA to enable the merging and analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and archiving data from the study in Kenya as well as data collected through a similar, ongoing study at health facilities in South Africa affiliated with IeDEA. This study will establish a multiregional PV infrastructure within IeDEA that can be further scaled within the broader IeDEA network.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (C1) | – | Other: Pharmacovigilance surveillance programProspective 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). |
| Cohort 2 (C2) | – | Other: Pharmacovigilance surveillance programCross-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. |
| Cohort 3 (C3) | – | Other: Pharmacovigilance surveillance programPhotos/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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant and postpartum women who are HIV+ and HIV- and their infants.
Key inclusion criteria (9 listed)
- 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
- All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none)
- Inclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacovigilance surveillance programThe 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). | Other | Cohort 1 (C1), Cohort 2 (C2), Cohort 3 (C3) |
Primary outcome
Pregnancy outcomes
Time frame: At time of delivery
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)
Infant/birth outcomes
Time frame: At 1, 6, and 12 months post-delivery
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Pregnancy Related, run by Indiana University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcomes (time frame: At time of delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.