Pregnancy Registry in Mali

Официальное название

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

Обзор

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

Подробное описание

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.

Первичные конечные точки

• Number of pregnancies [Срок оценки: Through study completion, an average of 1 year]
• Number of malaria cases [Срок оценки: Through study completion, an average of 1 year]
• Incidence of placental malaria [Срок оценки: Through study completion, an average of 1 year]
• Use of other malaria prevention tools [Срок оценки: Through study completion, an average of 1 year]
• Number of Participants with anemia during pregnancy and post-partum [Срок оценки: Through study completion, an average of 1 year]
• Dating of pregnancies [Срок оценки: Through study completion, an average of 1 year]
• Number of Maternal Deaths [Срок оценки: Through study completion, an average of 1 year]
• Number of fetal Losses and Stillbirths [Срок оценки: Through study completion, an average of 1 year]
• Number of multiple gestations [Срок оценки: Through study completion, an average of 1 year]
• Incidence of preterm delivery [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (9)

• Number of neonatal deaths [Срок оценки: Through study completion, an average of 1 year]
• Incidence of low Birth Weight (LBW) [Срок оценки: Through study completion, an average of 1 year]
• Incidence of preterm birth [Срок оценки: Through study completion, an average of 1 year]
• Occurrence and description of malformations [Срок оценки: Through study completion, an average of 1 year]
• Occurrence of Small for Gestational Age (SGA) [Срок оценки: Through study completion, an average of 1 year]
• Occurrence of malaria (symptomatic and asymptomatic) in neonates and infants [Срок оценки: Through study completion, an average of 1 year]
• Occurrence of anemia during infancy at 6 and 12 months of age [Срок оценки: Through study completion, an average of 1 year]
• Occurrence of neonatal/infant/pediatric adverse outcomes [Срок оценки: Through study completion, an average of 1 year]
• Timing of receipt of routine vaccinations [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Mali · 1 центр

• Kalifabougou MRTC Clinic — Kalifabougou

Идентификаторы

NCT: NCT06468319 · 2024/84/CE/USTTB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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