A Maternal Device to Reduce the Risk of Stillbirth and Low Birth-Weight

Allan Kember1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2015年9月1日最近更新: 2020年4月2日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 200
试验地点: 1
主要终点: Birthweight Centile

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences.

Sleeping on the back during pregnancy has recently emerged in scientific literature as a potential risk factor for SB and LBW. In fact, one of the earliest studies to demonstrate this link was conducted in Ghana by investigators on this protocol.

When a woman in mid-to-late-pregnancy lies on her back, her large uterus compresses one of the major veins that delivers blood back to her heart and may completely obstruct it. This may result in less blood being returned to her heart and less blood being pumped to her developing fetus. Such changes may negatively impact the growth of her fetus and, along with some other risk factors, may contribute to the death of her baby.

The investigators have developed a device, 'PrenaBelt', to significantly reduce the amount of time a pregnant woman spends sleeping on her back. The PrenaBelt functions via a simple, safe, effective, and well-established modality called positional therapy.

The purpose of this study is to determine the effect of the PrenaBelt on birth-weight and assess the feasibility of introducing it to Ghanaian third-trimester pregnant women in their home setting via an antenatal care clinic and local health-care staff. Data from this study will be used in effect size calculations for the design of a large-scale, epidemiological study targeted at reducing LBW and SB in Ghana and globally.

详细描述

Introduction:

According to the World Health Organization (WHO), stillbirth (SB) is defined as fetal death at gestation ≥28 weeks or weight ≥1000g. In addition to the loss of life for the stillborn baby, parents whose baby is stillborn must cope with the psychological grief of losing their baby, which results in markedly increased mortality in bereaved parents when compared with non-bereaved parents.

Low birth-weight (LBW) is defined as a weight less than 2500g at birth. LBW is a significant contributor to SB, and infants with LBW are 20 times more likely to die in the first year than heavier babies. Although LBW babies constitute only about 15% of live births, they account for 60-80% of neonatal deaths. Neonatal deaths (death within the first year of life) account for 40% of all deaths under the age of five years. LBW also accounts for significant morbidity such as cognitive impairment, and chronic diseases later in life. LBW arises through short gestation (preterm birth) or in-utero growth restriction, or both.

Women in Ghana suffer from one of the highest perinatal mortality rates in the world. Every day in Ghana, 47 babies are stillborn and 232 babies are born with LBW - many of whom will die in infancy or suffer lifelong consequences. As such, Ghana urgently requires inexpensive interventions to reduce perinatal morbidity and mortality - assisting pregnant Ghanaian women to avoid sleeping on their back might be one such intervention.

Background - Maternal Position:

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•≥18 years old
•low-risk singleton pregnancy
•entering the last trimester of pregnancy (in range 26-30 weeks of gestation)
•residing in the Greater Accra Metropolitan Area or area served by the Korle Bu Teaching Hospital
•fluent in either English, Twi, or Ga.

排除标准

•BMI ≥ 35 at booking (first antenatal appointment for current pregnancy)
•pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth])
•sleep complicated by medical conditions (known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder])
•multiple pregnancy
•known fetal abnormality
•maternal age >35

研究组 & 干预措施

PrenaBelt

Experimental

Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care.