The Antenatal and Postnatal Care Research Collective (ARC): Antenatal, Intrapartum andPostnatal Care: A Prospective, Longitudinal Study of Maternal and Newborn Health of the Pregnancy RiskStratification Innovation and Measurement Alliance (PRiSMA MNH Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Maternal Outcomes:
研究概览
简要总结
The ARC study isdesigned to reduce the risk of adverse pregnancyoutcomes through the following: 1) Increase the quality and quantity for ANC/IPC/PNCservices, 2) Improve risk prediction and management, 3) Ensure earlier initiation into ANC/IPC/PNC services, 4) Increasethe continuity of care across the continuum of care from ANC, IPC to PNC.
The goals areto develop a harmonized data set to improve our understanding of pregnancy riskfactors, vulnerabilities, and morbidity and mortality and to estimate theburden of these risk factors and outcomes in LMICs. Ultimately, these data willinform the development of innovative strategies to optimize pregnancy outcomesfor mothers and their newborns.
It will bea prospective, open cohort study. All eligible pregnant women will be followedthrough the antenatal, intrapartum and postnatal periods and infants throughone year of age
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •A pregnant woman who meets the following inclusion criteria may be enrolled at any stage of her pregnancy: Women with confirmed pregnancy identified within the study catchment area through pregnancy surveillance and at study health facility.
排除标准
- •Decline to provide consent
- •Inability to provide informed consent
- •Less than 18 years of age.
结局指标
主要结局
Maternal Outcomes:
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
1. Maternal mortality & Severe maternal morbidity
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
2. Maternal anemia
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
2. 7-day neonatal mortality
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
Fetal and Neonatal outcomes
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
1. Stillbirth
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
3. 28-day neonatal mortality
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
4. Preterm birth
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
5. Low birth weight delivery
时间窗: Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery | Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth
次要结局
- Fetal and newborn outcomes(1. Stillbirth (antepartum))
- Maternal outcomes and conditions(1. Late maternal mortality)
- Quality of care indicators(1. Number of ANC visits)