Assessment of Pregnancy Outcomes Through Demographic Surveillance and Prospective Data Collection at a Health Facility in Kalifabougou, Mali
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9,500
- 试验地点
- 1
- 主要终点
- Number of fetal Losses and Stillbirths
研究概览
简要总结
This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Number of fetal Losses and Stillbirths
时间窗: 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
Incidence of preterm delivery
时间窗: Through study completion, an average of 1 year
Preterm delivery (≥28 to \<37 weeks)
Occurrence of chronic medical conditions
时间窗: 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
时间窗: 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
Number of malaria cases
时间窗: 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
Use of other malaria prevention tools
时间窗: Through study completion, an average of 1 year
Recorded by survey
Number of Maternal Deaths
时间窗: Through study completion, an average of 1 year
Dating of pregnancies
时间窗: Through study completion, an average of 1 year
Measured at each ANC visit by ultrasound and last menstrual period
Number of pregnancies
时间窗: Through study completion, an average of 1 year
Detected by urine or serum by active and passive screening
Incidence of placental malaria
时间窗: Through study completion, an average of 1 year
Detected by blood smear or pathology/histology, at delivery
Number of Participants with anemia during pregnancy and post-partum
时间窗: Through study completion, an average of 1 year
Defined as hemoglobin level less than 11 g/dL
Number of multiple gestations
时间窗: Through study completion, an average of 1 year
Twins, triplets, or multiple gestations during pregnancy
次要结局
- Number of neonatal deaths(Through study completion, an average of 1 year)
- Occurrence and description of malformations(Through study completion, an average of 1 year)
- Occurrence of neonatal/infant/pediatric adverse outcomes(Through study completion, an average of 1 year)
- Incidence of low Birth Weight (LBW)(Through study completion, an average of 1 year)
- Incidence of preterm birth(Through study completion, an average of 1 year)
- Timing of receipt of routine vaccinations(Through study completion, an average of 1 year)
- Occurrence of anemia during infancy at 6 and 12 months of age(Through study completion, an average of 1 year)
- Occurrence of malaria (symptomatic and asymptomatic) in neonates and infants(Through study completion, an average of 1 year)
- Occurrence of Small for Gestational Age (SGA)(Through study completion, an average of 1 year)