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临床试验/NCT03673709
NCT03673709已完成不适用

Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi

University of Illinois at Chicago7 个研究点 分布在 1 个国家目标入组 1,887 人开始时间: 2019年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,887
试验地点
7
主要终点
Preterm birth

研究概览

简要总结

In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care (Aim 1) across 7 antenatal clinics in Blantyre District, Malawi. If results are negative, governments will avoid spending on ineffective care. Positive maternal, neonatal and HIV-related outcomes of group antenatal care will save lives, impact the cost and quality of antenatal care, and influence health policy as governments adopt this innovative model of care nationally.

详细描述

Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for 2/3 of new HIV infections and 1/4 of preterm births. Antenatal (prenatal) care is the entry point into the health system for many women and offers a unique opportunity to provide life-saving monitoring. However, provider shortages, low quality of care and failure to attend all recommended visits mean that the potential benefits of antenatal care are not realized. There is an urgent need to test novel interventions to reduce health risks for mother and child. Group antenatal care is a transformative model of care that provides a positive pregnancy experience, uses provider time efficiently, and improves perinatal and HIV-related outcomes. Women in group antenatal care have 2-hour visits with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women conduct self-assessments, briefly consult the midwife, and meet for 80-90 minutes of interactive health promotion enlivened by games and role-plays. Women form relationships with midwives and each other. In a US randomized clinical trial (RCT), group care improved prematurity rates, antenatal care attendance, satisfaction with care, breastfeeding practices, safer sex behaviors, and uptake of family planning. Our randomized pilot in Malawi and Tanzania had promising outcomes. More women in group care than in usual care completed ≥4 antenatal visits (94% vs 58%). Their partners were more likely to be tested for HIV during pregnancy (51% vs. 27%). We established that group antenatal care can be offered in a rigorous RCT with high fidelity despite provider shortages. The next step is an adequately powered effectiveness trial. Malawi is an especially appropriate site because it has the world's highest prematurity rate (18%) and high HIV prevalence (10% nationally, 16% at the study site). We conducted an effectiveness RCT with individual-level randomization. Aim 1 is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that compared to usual care, women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We test Aim 1 hypotheses using multi-level hierarchical models using data from repeated surveys and health records. This high-impact study addresses three global health priorities, maternal and infant mortality and HIV prevention, that affect all women of childbearing age in Malawi. The Ministry of Health strongly supports this project; results will help them decide whether to scale-up this innovative model of group care. Negative results will avoid spending on ineffective care. Positive results will provide evidence needed to adopt group antenatal care nationally and in other low-resource countries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

The research team working on the effectiveness evaluation of group care is blinded to study condition and is charged with collecting the Aim 1 effectiveness data from the individuals.

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant, 24 weeks gestation or less, no marked cognitive impairment, speaks and understands Chichewa (the national language)

排除标准

  • Not pregnant, more than 24 weeks gestation, marked cognitive impairment, does not speak or understand Chichewa (the national language)

研究组 & 干预措施

Individual Antenatal Care (usual care)

No Intervention

Women are provided antenatal care services on a first come, first serve basis and listen to a health lecture. They meet individually with a midwife for a physical assessment. Women complete laboratory tests (including HIV testing) at their first visit. Congruent with the new World Health Organization (WHO) recommendations, individual antenatal care consists of 8 antenatal care visits and 2 postnatal visits at 1 week and 6 weeks.

Group Antenatal Care (intervention)

Experimental

Women have the same number of visits as those in individual care. Their first antenatal care (intake) and first postnatal visit is done individually (identical to individual care). Women in group care bypass the waiting area and have a 2-hour visit with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women assess their blood pressure and weight, briefly consult the midwife in a corner of the room, and meet for 80-90 minutes of interactive health promotion, enlivened by games and role-plays.

干预措施: Antenatal Care (Behavioral)

结局指标

主要结局

Preterm birth

时间窗: 8 weeks postpartum

Newborn born early

Partner HIV Test

时间窗: Enrollment, 36-42 weeks gestation

Proportion of partners tested during this pregnancy

Born Weighing Less Than 2500 g

时间窗: 8 weeks postpartum

Whether a newborn weighed \<2,500 grams at birth (yes/no) is used as a proxy for preterm birth due to the lack of accurate gestational age data.

Partner HIV Test

时间窗: 36-42 weeks gestation

Proportion of partners tested during this pregnancy

次要结局

  • Low birthweight(8 weeks postpartum)
  • Stillbirth(8 weeks postpartum)
  • Maternal death(8 weeks postpartum, 6 months postpartum)
  • Woman HIV test(Enrollment, 36-42 weeks gestation)
  • Anemia(Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum)
  • Family planning(8 weeks postpartum; 6 months postpartum)
  • ART medication (woman)(Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum)
  • Healthcare utilization(36-42 weeks gestation; 8 weeks postpartum)
  • Self Reporting Questionnaire (SRQ)(Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum)
  • Neonatal death(8 weeks postpartum)
  • Spontaneous abortion(36-42 weeks gestation)
  • Exclusive breastfeeding(8 weeks postpartum; 6 months postpartum)
  • Early repeat pregnancy(8 weeks postpartum; 6 months postpartum)
  • HIV test infant(Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum)
  • Adequate HIV knowledge(Enrollment, 36-42 weeks gestation)
  • Satisfaction with care(36-42 weeks gestation)
  • Spontaneous Abortion(36-42 weeks gestation)
  • Infant Death(6 months postpartum)
  • Maternal Death(6 months postpartum)
  • Anemia(36-42 weeks gestation)
  • Family Planning(6 months postpartum)
  • Exclusive Breastfeeding(6 months postpartum)
  • Self Reporting Questionnaire (SRQ)(8 weeks postpartum)
  • Satisfaction With Antenatal Care (ANC)(36-42 weeks gestation)
  • Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct(36-42 weeks gestation)
  • Mean Antenatal Care (ANC) Contacts(8 weeks postpartum)
  • Pregnancy-related Empowerment Scale (PRES)(36 to 42 weeks gestation)
  • Wait Time(36-42 weeks gestation)
  • Prefer Group Antenatal Care (ANC) in the Future(36-42 weeks gestation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystal L. Patil, PhD

Professor

University of Illinois at Chicago

研究点 (7)

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