MalariaNCT06468319
Pregnancy Registry in Mali
An observational study of Malaria and Pregnancy Related, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria, Pregnancy Related
- How many people
- 9,500 participants
- Where
- 1 siteMali
- Study dates
- 5 Aug 2024to Jun 2030
- How long will I take part?
- 5 Years
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Malian females of childbearing age (15-49 years) Community Census Cohort: 4000 unique women Health Facility Cohort: 2500 unique women (inclusive of women who transition for enrollment from the Community Census Cohort) Offspring from Health Facility Cohort: 3000 children
Who may be able to join
- Community Census Cohort:
- Females of childbearing potential or pregnant females.
- Aged 15 to 49 years.
- Able to provide verbal individual informed consent.
- Health Facility Cohort:
- Pregnant females 15 to 49 years and their subsequent offspring.
- Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.
- Able to provide written individual informed consent for herself and her future offspring(s).
Who cannot join
- Community Census Cohort:
- Temporary residence in the study area.
- Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
- Health Facility Cohort:
- Temporary residence in the study area.
- Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mali1 site, 1 recruiting
- Recruiting
Kalifabougou MRTC Clinic
Kalifabougou, Koulikoro
Kassoum Kayentao, MD, MPH, PhD, +223 7646 0173, kayentao@icermali.org
About this study
Official title: Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
Read the detailed description
This pregnancy registry will gather background data on pregnancy rates and outcomes as well as infant health data to inform future implementation of clinical trials testing monoclonal antibodies (mAbs) to prevent malaria in pregnancy.
In the first part of the study (Community Census Cohort), women of child-bearing age (WOCBA) in the community will be identified and followed for up to 3 years to detect pregnancy at all stages. Upon detection of pregnancy, these women may then transition to participation in the Health Facility Cohort.
In the second part of the study (Health Facility Cohort), data will be prospectively collected from pregnant women presenting at the health facility for antenatal care (ANC) visits or referred in from the Community Census Cohort. The pregnant women will be followed through pregnancy outcome and until 12 months postpartum, and their infant(s) will be followed until 12 months of age.
The study team will collect baseline information in a systematic manner on early pregnancy events, pregnancy and postpartum complications and outcomes, utilization of existing malaria prevention tools, malaria infections and clinical disease, birth outcomes, and follow-up of subsequent offspring.
- Conditions
- Malaria, Pregnancy Related
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community Census Cohort | Women of child-bearing aged (WOCBA) identified within the community. | |
| Health Facility Cohort | Pregnant women presenting at the health facility for antenatal care or referred in from the Community Consensus Cohort. | |
| Offspring from Health Facility Cohort | Children born to women in the health facility cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pregnancies
Detected by urine or serum by active and passive screening
Measured: Through study completion, an average of 1 year
Number of malaria cases
Detected by RDT and/or blood smear and/or PCR during pregnancy defined as any parasitemia with or without malaria symptoms
Measured: Through study completion, an average of 1 year
Incidence of placental malaria
Detected by blood smear or pathology/histology, at delivery
Measured: Through study completion, an average of 1 year
Use of other malaria prevention tools
Recorded by survey
Measured: Through study completion, an average of 1 year
Number of Participants with anemia during pregnancy and post-partum
Defined as hemoglobin level less than 11 g/dL
Measured: Through study completion, an average of 1 year
Dating of pregnancies
Measured at each ANC visit by ultrasound and last menstrual period
Measured: Through study completion, an average of 1 year
Number of Maternal Deaths
Measured: Through study completion, an average of 1 year
Number of fetal Losses and Stillbirths
Pregnancies terminated in the first trimester (<=12 weeks) and in the second trimester (>12 and <28 weeks) and stillbirth
Measured: Through study completion, an average of 1 year
Number of multiple gestations
Twins, triplets, or multiple gestations during pregnancy
Measured: Through study completion, an average of 1 year
Incidence of preterm delivery
Preterm delivery (≥28 to <37 weeks)
Measured: Through study completion, an average of 1 year
Occurrence of chronic medical conditions
Description and reporting of occurrence of chronic medical conditions during pregnancy and/or post-partum
Measured: Through study completion, an average of 1 year
Occurrence of pregnancy and post-partum adverse outcomes
Description and reporting of occurrence of pregnancy and post-partum adverse outcomes including but not limited to gestational diabetes, gestational hypertension, pre-eclampsia, eclampsia, postpartum hemorrhage, and postpartum depression
Measured: Through study completion, an average of 1 year
Secondary outcomes (9)
Number of neonatal deaths
Neonatal death as defined as early (≤7 days) or late (>7 days ≤28 days) after delivery
Measured: Through study completion, an average of 1 year
Incidence of low Birth Weight (LBW)
LBW as defined as <2.5 kg at birth
Measured: Through study completion, an average of 1 year
Incidence of preterm birth
Preterm birth (≥28 to <37 weeks)
Measured: Through study completion, an average of 1 year
Occurrence and description of malformations
Occurrence and description of malformations identified at delivery and within the first 6 months of life
Measured: Through study completion, an average of 1 year
Occurrence of Small for Gestational Age (SGA)
defined as newborns whose birth weight is <10th percentile for gestational age as defined by INTERGROWTH-21st international standards
Measured: Through study completion, an average of 1 year
Occurrence of malaria (symptomatic and asymptomatic) in neonates and infants
Detected by RDT and/or blood smear and/or PCR at birth and throughout first year of life defined as any parasitemia with or without malaria symptoms
Measured: Through study completion, an average of 1 year
Occurrence of anemia during infancy at 6 and 12 months of age
Anemia during infancy as defined by age of testing
Measured: Through study completion, an average of 1 year
Occurrence of neonatal/infant/pediatric adverse outcomes
Description and reporting of occurrence of neonatal/infant/pediatric adverse outcomes
Measured: Through study completion, an average of 1 year
Timing of receipt of routine vaccinations
Reporting and timing of receipt of routine vaccinations, including malaria vaccines, and other standard of care anti-malarial treatment
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start5 Aug 2024
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- 9,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), University of Washington
- Responsible party
- Sponsor
- Investigators
- Kassoum Kayentao, MD, MPH, PhD, Principal investigator, Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)Peter Crompton, MD, MPH, Principal investigator, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468319
- Sponsor's protocol ID
- 2024/84/CE/USTTB
- Status last verified
- Mar 2026
- First submitted
- 28 May 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali
- ClinicalTrials.gov ID
- NCT06468319
- Acronym / sponsor ID
- 2024/84/CE/USTTB
- Conditions
- Malaria, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,500 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), University of Washington
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 21 Jun 2024 (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.
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
Detailed description
This pregnancy registry will gather background data on pregnancy rates and outcomes as well as infant health data to inform future implementation of clinical trials testing monoclonal antibodies (mAbs) to prevent malaria in pregnancy.
In the first part of the study (Community Census Cohort), women of child-bearing age (WOCBA) in the community will be identified and followed for up to 3 years to detect pregnancy at all stages. Upon detection of pregnancy, these women may then transition to participation in the Health Facility Cohort.
In the second part of the study (Health Facility Cohort), data will be prospectively collected from pregnant women presenting at the health facility for antenatal care (ANC) visits or referred in from the Community Census Cohort. The pregnant women will be followed through pregnancy outcome and until 12 months postpartum, and their infant(s) will be followed until 12 months of age.
The study team will collect baseline information in a systematic manner on early pregnancy events, pregnancy and postpartum complications and outcomes, utilization of existing malaria prevention tools, malaria infections and clinical disease, birth outcomes, and follow-up of subsequent offspring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community Census Cohort | – | –Women of child-bearing aged (WOCBA) identified within the community. |
| Health Facility Cohort | – | –Pregnant women presenting at the health facility for antenatal care or referred in from the Community Consensus Cohort. |
| Offspring from Health Facility Cohort | – | –Children born to women in the health facility cohort. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Malian females of childbearing age (15-49 years) Community Census Cohort: 4000 unique women Health Facility Cohort: 2500 unique women (inclusive of women who transition for enrollment from the Community Census Cohort) Offspring from Health Facility Cohort: 3000 children
Key inclusion criteria (8 listed)
- Females of childbearing potential or pregnant females.
- Aged 15 to 49 years.
- Able to provide verbal individual informed consent.
- Pregnant females 15 to 49 years and their subsequent offspring.
- Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.
Key exclusion criteria (6 listed)
- Temporary residence in the study area.
- Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
- Temporary residence in the study area.
- Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of pregnancies
Time frame: Through study completion, an average of 1 year
Detected by urine or serum by active and passive screening
Number of malaria cases
Time frame: Through study completion, an average of 1 year
Detected by RDT and/or blood smear and/or PCR during pregnancy defined as any parasitemia with or without malaria symptoms
Incidence of placental malaria
Time frame: Through study completion, an average of 1 year
Detected by blood smear or pathology/histology, at delivery
Use of other malaria prevention tools
Time frame: Through study completion, an average of 1 year
Recorded by survey
Number of Participants with anemia during pregnancy and post-partum
Time frame: Through study completion, an average of 1 year
Defined as hemoglobin level less than 11 g/dL
Dating of pregnancies
Time frame: Through study completion, an average of 1 year
Measured at each ANC visit by ultrasound and last menstrual period
Number of Maternal Deaths
Time frame: Through study completion, an average of 1 year
Number of fetal Losses and Stillbirths
Time frame: Through study completion, an average of 1 year
Pregnancies terminated in the first trimester (<=12 weeks) and in the second trimester (>12 and <28 weeks) and stillbirth
Number of multiple gestations
Time frame: Through study completion, an average of 1 year
Twins, triplets, or multiple gestations during pregnancy
Incidence of preterm delivery
Time frame: Through study completion, an average of 1 year
Preterm delivery (≥28 to <37 weeks)
Occurrence of chronic medical conditions
Time frame: Through study completion, an average of 1 year
Description and reporting of occurrence of chronic medical conditions during pregnancy and/or post-partum
Occurrence of pregnancy and post-partum adverse outcomes
Time frame: Through study completion, an average of 1 year
Description and reporting of occurrence of pregnancy and post-partum adverse outcomes including but not limited to gestational diabetes, gestational hypertension, pre-eclampsia, eclampsia, postpartum hemorrhage, and postpartum depression
9 secondary outcomes
Number of neonatal deaths
Time frame: Through study completion, an average of 1 year
Incidence of low Birth Weight (LBW)
Time frame: Through study completion, an average of 1 year
Incidence of preterm birth
Time frame: Through study completion, an average of 1 year
Occurrence and description of malformations
Time frame: Through study completion, an average of 1 year
Occurrence of Small for Gestational Age (SGA)
Time frame: Through study completion, an average of 1 year
Occurrence of malaria (symptomatic and asymptomatic) in neonates and infants
Time frame: Through study completion, an average of 1 year
Occurrence of anemia during infancy at 6 and 12 months of age
Time frame: Through study completion, an average of 1 year
Occurrence of neonatal/infant/pediatric adverse outcomes
Time frame: Through study completion, an average of 1 year
Timing of receipt of routine vaccinations
Time frame: Through study completion, an average of 1 year
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 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kassoum Kayentao, MD, MPH, PhD principal investigator
Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS)
Peter Crompton, MD, MPH principal investigator
National Institutes of Health (NIH)
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 Malaria and Pregnancy Related, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
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 8 inclusion and 6 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 13 Mar 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 Mali. 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?
Contact Kassoum Kayentao, MD, MPH, PhD (+223 7646 0173, kayentao@icermali.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pregnancies (time frame: Through study completion, an average of 1 year). The study lists 12 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 13 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.