Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy by Regular Monitoring of Weight Gain and Blood Pressure: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
Background:
- Burden: Hypertensive disorders of pregnancy, including preeclampsia, complicate up to 10% of pregnancies worldwide, constituting one of the greatest causes of fetal growth restriction, preterm birth, low birth weight, perinatal mortality, and maternal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive causes. Conventional antenatal care practice often delays in or misses diagnosing hypertension in pregnancy, which makes the women vulnerable to its adverse consequences.
- Knowledge gap: Although there are randomised controlled trials (RCT) of efforts directed at preventing development of hypertension in pregnancy or reducing its complications, there have been no published RCTs of the intervention focusing on regular monitoring of weight gain and blood pressure among pregnant women who are at risk of developing hypertension in pregnancy or its complications to ensure early diagnosis, and thereby optimizing the perinatal outcomes through prompt referral and management.
- Relevance: To undertake an RCT of intervention to optimize adverse consequences in hypertension in pregnancy raises important practical concerns including: commitment of the enrolled women, the need to make a decision regarding participation due to longer duration of intervention and adherence to protocol. Investigators aim to perform this study to address whether an RCT of the intervention in individual patients is an appropriate trial design, and is feasible.
Objectives:
- To evaluate the accuracy of Salu Health Gauge device in measuring blood pressure.
- To test the design, feasibility, acceptability and fidelity of a future definitive randomized controlled trial focusing on regular monitoring of weight gain and continuous self-monitoring of blood pressure among pregnant women who are at risk of developing hypertension in pregnancy.
Methods:
The study will be completed in two steps: 1) the validation of Salu Health Gauge and 2) the pilot trial. The study will be conducted in Matlab, Bangladesh. Salu Health Gauge device will be validated according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010) in general adult population (including men and non-pregnant women) as well as in specific groups such as adolescents and pregnant women. The pilot trial is designed as a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. Eligible participants (pregnant women at risk of developing hypertension in pregnancy) will be individually randomized 1:1 to the intervention arm who will use a wearable device (Salu Health Gauge) from 20 weeks of gestation up to termination of pregnancy alongside conventional antenatal and postnatal care or the control arm who will receive conventional antenatal and postnatal care only. In Matlab, a woman is diagnosed as pregnant by HDSS field staff by 12-16 weeks of gestation and is enlisted. The investigators will obtain this list from HDSS and conduct baseline interviews to identify pregnant women at risk of developing hypertension in pregnancy.
Outcome measures/variables:
- Feasibility outcomes: Recruitment rate, Retention rate, compliance, Acceptability etc.
- Clinical outcomes: gestational weight gain, birth weight, adverse consequence of hypertension in pregnancy (episodes or occurrence and when), blood pressure profile of high-risk pregnancies, prevalence of specific risk factors for hypertension in pregnancy
- Serious adverse events
详细描述
Background of the Project including Preliminary Observations Hypertensive disorders of pregnancy, including preeclampsia, complicate up to 10% of pregnancies worldwide, constituting one of the greatest causes of fetal growth restriction, preterm birth, low birth weight, perinatal mortality, and maternal morbidity and mortality.
Odegard et al. found that hypertension in pregnancy, particularly severe and early-onset preeclampsia were associated with significant fetal growth restriction. They showed that preeclampsia was associated with a 5% (95% CI 3%, 6%) reduction in birth weight. In severe preeclampsia, the reduction was 12% (95% CI 9%, 15%), and in early-onset disease, birth weight was 23% (95% CI 18%, 29%) lower than expected. The risk of small-for-gestational-age (SGA) birth was four times higher (relative risk = 4.2; 95% CI 2.2, 8.0) in infants born after preeclampsia.
Pre-eclampsia is also responsible for preterm birth, either spontaneous or through iatrogenic delivery. Lancet Pre-eclampsia series estimated that severe pre-eclampsia increased the risk of preterm delivery by 15-67%, and fetal growth restriction by 10-25%.
Hypertensive disorders of pregnancy are the most common causes of maternal mortality in Europe and are responsible for one-tenth of the maternal deaths in Asia and Africa. Prevalence of preeclampsia, the vilest form of hypertensive disorders of pregnancy, is 12% in Bangladesh. Hypertension in pregnancy or its complications can happen any time during pregnancy, delivery or postnatal period.
Definition and classification of hypertensive disorders in pregnancy Hypertensive disorders of pregnancy are diagnosed by systolic blood pressure (BP) of 140 mmHg or greater and/or diastolic BP of 90 mmHg or greater on at least two occasions more than 4 h apart while resting. Preexisting hypertension may not be evident in the first and second trimesters owing to the physiologic reduction in BP, thus causing confusion with gestational hypertension. Hypertensive disorders of pregnancy or their complications usually manifest after 20 weeks of pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Neither the participants nor the investigators or the assessors of outcomes can be blinded to allocation because of the obvious nature and the delivery procedure of the interventions which investigators are going to provide and thus, investigators are obliged to make the RCT non-blinded/open. However, it is prudent to mention that the outcomes of the trial are of objective nature. Furthermore, the randomization, as well as statistical analysis, will be carried out by someone unconnected to the recruitment process.
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •High risk pregnancy
- •At 12-16 weeks of gestation
- •Aged between 15 to 50 years
- •Living in Matlab bangladesh
排除标准
- •Have congenital malformation/anomaly in current pregnancy
- •Current pregnancy have chromosomal abnormality e.g. Down syndrome
- •Have chronic debilitating illness
- •Mother is a known case of psychosis
- •Who do not have electricity at their house
- •Do not have smart phone at their house
结局指标
主要结局
Retention rate
时间窗: Till the follow-up period (from 20 weeks to until delivery or termination of the pregnancy) ends
Retention rate is defined as the proportion of participants who will fully participate in the study until follow-up period (from 20 week up to the delivery) ends.
Acceptability of the BP measurement
时间窗: 5 months
Participant acceptability of the BP measurement procure as a part of the intervention will be assessed two times during the follow-up period using a Likert scale with 5 level of qualitative response as well as by asking qualitative questions. The quantitative result will be reported as median (interquartile range) score for combined and period specific outcomes. They will be assessed once during the third trimester and in the end of the study. The qualitative part will be reported narratively.
Recruitment rate
时间窗: 6 months
Recruitment rate is defined as number of participants recruited per month on average. This outcome is important because unforeseen enrolment challenges are crucial to identify in a pilot RCT.
Adherence to protocol (compliance)
时间窗: 5 months
Adherence is defined as the proportion of participants following the intervention protocol. There may be a number of reasons why the participant do not follow the intervention protocol properly. FFWs will enquire the reasons during weekly visits and note the causes and the number of times they have violated the protocol in a log sheet. Understandable protocol deviations (e.g., participant died) will be distinguished from protocol violations (e.g., participant removed the wearable gauge).
Acceptability of the device
时间窗: 5 months
Participant acceptability of the device as intervention will be assessed two times during the follow-up period using a Likert scale with 5 level of qualitative response as well as by asking qualitative questions. The quantitative result will be reported as median (interquartile range) score for combined and period specific outcomes. They will be assessed once during the third trimester and in the end of the study. The qualitative part will be reported narratively. up period using a Likert scale as well as by asking qualitative questions. The quantitative result will be reported as median (interquartile range) score for combined and period specific outcome. They will be assessed once during the second trimester, once during the third trimester and finally once during the postnatal period. The qualitative part will be reported narratively.
次要结局
- Sociodemographic profile(6 months)
- Heart rate profile of high risk pregnancies(20 week of gestation up to termination of pregnancy)
- Sleeping status of mothers(20 week of gestation up to termination of pregnancy)
- Birth weight(20 week of gestation up to termination of pregnancy)
- Adverse consequence of hypertension in pregnancy(20 week of gestation up to termination of pregnancy)
- Rate of gestational weight gain(20 week of gestation up to termination of pregnancy)
- Rate of daily activity(20 week of gestation up to termination of pregnancy)
- Blood pressure profile of high risk pregnancies(20 week of gestation up to termination of pregnancy)