Pregnancy Registry in Mali

Malaria Clinical Trial

Official title:

Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468319
• Other study ID #: 2024/84/CE/USTTB
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2030

Study information

• Verified date: June 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: Kassoum Kayentao, MD, MPH, PhD
• Phone: +223 7646 0173
• Email: kayentao[@]icermali.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9500
• Est. completion date: June 2030
• Est. primary completion date: June 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

Community Census Cohort:

1. Females of childbearing potential or pregnant females.

2. Aged 15 to 49 years.

3. Able to provide verbal individual informed consent.

Health Facility Cohort:

1. Pregnant females 15 to 49 years and their subsequent offspring.

2. Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.

3. Able to provide written individual informed consent for herself and her future offspring(s).

Exclusion Criteria:

Community Census Cohort:

1. Temporary residence in the study area.

2. 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:

1. Temporary residence in the study area.

2. 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.

Related Conditions & MeSH terms

• Malaria
• Pregnancy Related

Locations

Country	Name	City	State
Mali	Kalifabougou MRTC Clinic	Kalifabougou	Région De Koulikoro

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	National Institutes of Health (NIH), University of Washington

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pregnancies	Detected by urine or serum by active and passive screening	Through study completion, an average of 1 year
Primary	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	Through study completion, an average of 1 year
Primary	Incidence of placental malaria	Detected by blood smear or pathology/histology, at delivery	Through study completion, an average of 1 year
Primary	Use of other malaria prevention tools	Recorded by survey	Through study completion, an average of 1 year
Primary	Number of Participants with anemia during pregnancy and post-partum	Defined as hemoglobin level less than 11 g/dL	Through study completion, an average of 1 year
Primary	Dating of pregnancies	Measured at each ANC visit by ultrasound and last menstrual period	Through study completion, an average of 1 year
Primary	Number of Maternal Deaths		Through study completion, an average of 1 year
Primary	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	Through study completion, an average of 1 year
Primary	Number of multiple gestations	Twins, triplets, or multiple gestations during pregnancy	Through study completion, an average of 1 year
Primary	Incidence of preterm delivery	Preterm delivery (=28 to <37 weeks)	Through study completion, an average of 1 year
Primary	Occurrence of chronic medical conditions	Description and reporting of occurrence of chronic medical conditions during pregnancy and/or post-partum	Through study completion, an average of 1 year
Primary	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	Through study completion, an average of 1 year
Secondary	Number of neonatal deaths	Neonatal death as defined as early (=7 days) or late (>7 days =28 days) after delivery	Through study completion, an average of 1 year
Secondary	Incidence of low Birth Weight (LBW)	LBW as defined as <2.5 kg at birth	Through study completion, an average of 1 year
Secondary	Incidence of preterm birth	Preterm birth (=28 to <37 weeks)	Through study completion, an average of 1 year
Secondary	Occurrence and description of malformations	Occurrence and description of malformations identified at delivery and within the first 6 months of life	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year
Secondary	Occurrence of anemia during infancy at 6 and 12 months of age	Anemia during infancy as defined by age of testing	Through study completion, an average of 1 year
Secondary	Occurrence of neonatal/infant/pediatric adverse outcomes	Description and reporting of occurrence of neonatal/infant/pediatric adverse outcomes	Through study completion, an average of 1 year
Secondary	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	Through study completion, an average of 1 year