Pregnancy Registry in Mali
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malaria, Pregnancy Related. Basic parameters: 15 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mali
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali
Overview
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.
Primary outcome measures
- Number of pregnancies [Time frame: Through study completion, an average of 1 year]
- Number of malaria cases [Time frame: Through study completion, an average of 1 year]
- Incidence of placental malaria [Time frame: Through study completion, an average of 1 year]
- Use of other malaria prevention tools [Time frame: Through study completion, an average of 1 year]
- Number of Participants with anemia during pregnancy and post-partum [Time frame: Through study completion, an average of 1 year]
- Dating of pregnancies [Time frame: Through study completion, an average of 1 year]
- 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]
- Number of multiple gestations [Time frame: Through study completion, an average of 1 year]
- Incidence of preterm delivery [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
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).
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Mali · 1 center
- Kalifabougou MRTC Clinic — Kalifabougou
Identifiers
NCT: NCT06468319 · 2024/84/CE/USTTB