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Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy

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ClinicalTrials.gov Identifier: NCT03858595
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : January 9, 2020
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Salu Design Group
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Background:

  1. 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.
  2. 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.
  3. 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:

  1. To evaluate the accuracy of Salu Health Gauge device in measuring blood pressure.
  2. 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:

  1. Feasibility outcomes: Recruitment rate, Retention rate, compliance, Acceptability etc.
  2. 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
  3. Serious adverse events

Condition or disease Intervention/treatment Phase
Hypertension, Pregnancy-Induced Hypertension, Essential Hypertension Hypertension; Pre-Eclampsia Hypertension in Pregnancy Device: Self monitoring of blood pressure using Health Gauge Device and monthly monitoring of weight gain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is designed as a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. Eligible participants (high-risk pregnant women) will be individually randomized 1:1 to the intervention arm who will regularly monitor their nutritional status (rate of gestational weight gain) using a digital weighing scale and continuously self-monitor their blood pressure using a wearable device (Salu Health Gauge) from 20 weeks of gestation up to termination of to pregnancy alongside conventional antenatal and postnatal care or the control arm who will receive conventional antenatal and postnatal care only.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Intervention
Women in the intervention arm will be provided with the "Health Gauge" device. With this device, the women will be able to do self-monitoring of blood pressure as well as a few other things like heart rate, daily activities. Investigators will train our study participants (high-risk pregnant women) on how to use Salu Health Gauge to measure BP as well as how to charge them. Trained FFWs will visit the households weekly and synchronize the device with a tablet computer to collect the stored data. The FFWs will measure the weight of the participants using a digital weighing scale at enrollment and on a monthly bases thereafter. Investigators will keep monitoring up to termination of pregnancy. in any health issue arises, our health worker will ensure that an appropriate referral is made to a tertiary care facility. This intervention will be in addition to the conventional antenatal and postnatal care.
Device: Self monitoring of blood pressure using Health Gauge Device and monthly monitoring of weight gain
Women in the intervention arm will be provided with the "Health Gauge" device. With this device, the women will be able to do self-monitoring of blood pressure as well as a few other things like heart rate, daily activities. We will also measure weight gain of the mothers at monthly basis.

No Intervention: Control group
All those women randomized to the control arm will receive conventional antenatal and postnatal care only. Investigators will collect the outcome data from the households and/or the health centers by follow-up visits or over phone. Investigators will consell participants, women both in the control group, to make at least four antenatal visits. In addition, Investigators will provide counselling about eating healty and keeping physically active during pregnancy. Investigators will provide general nutrition education on taking balanced energy and protein diet.



Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 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.

  2. Retention rate [ Time Frame: 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.

  3. Adherence to protocol (compliance) [ Time Frame: 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).

  4. Acceptability of the device [ Time Frame: 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.

  5. Acceptability of the BP measurement [ Time Frame: 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.


Secondary Outcome Measures :
  1. Rate of gestational weight gain [ Time Frame: 20 week of gestation up to termination of pregnancy ]
    The investigators will measure the gestational weight gain by using increase of maternal weight per month and increase of maternal weight per week. Weight will be measured in kilograms.

  2. Birth weight [ Time Frame: 20 week of gestation up to termination of pregnancy ]
    The investigators will record birth weight in every viable births and will record in grams (gm). Then investigators will compare the birth weight between two groups.

  3. Adverse consequence of hypertension in pregnancy [ Time Frame: 20 week of gestation up to termination of pregnancy ]
    The investigators will measure the adverse consequences of pregnancy due to hypertension during pregnancy. The investigators will record all the episodes or occurrence of adverse events. This will compared in descriptive nature and compare between groups. Adverse events will be for mothers are: abruptio placenta, Disseminated coagulopathy, Pulmonary oedema/aspiration, acute renal failure, eclampsia, liver failure or hemorrhage, stroke, death. Fetal events like intrauterine death/stillbirth, preterm birth, small-for-gestational age, low birth weight, Hypoxia-neurologic injury, neonatal death, complications associated with LBW or preterm births

  4. Blood pressure profile of high risk pregnancies [ Time Frame: 20 week of gestation up to termination of pregnancy ]
    The investigators will motivate mothers to measure blood pressure in mm/Hg for at least six times in a day. Then investigators will prepare a complete profile of blood pressure for her pregnancy from 20 weeks of gestation up to the termination of pregnancy for each participants in intervention groups. The investigators will also make a profile of blood pressure among control groups with their recorded data measured by their respective health professionals (doctors and health workers). The investigators will take the average and compare the blood pressure in different time periods.

  5. Heart rate profile of high risk pregnancies [ Time Frame: 20 week of gestation up to termination of pregnancy ]
    The investigators will motivate the mothers to measure the heart rate for 6 times a day with the health Gauge device. Then heart rate will be calculated in beats per minutes.

  6. Rate of daily activity [ Time Frame: 20 week of gestation up to termination of pregnancy ]
    The investigators will measure the daily activity of pregnant mothers who are at risk of hypertension by step counts per day during their observation period.

  7. Sleeping status of mothers [ Time Frame: 20 week of gestation up to termination of pregnancy ]
    The investigators will take data related to sleeping status of mothers and will be recorded as number of hours passed in different stages of sleeps. The investigators will make a profile for those mothers have higher risk for pregnancy related hypertension

  8. Sociodemographic profile [ Time Frame: 6 months ]
    The investigators will take the data of those mothers enrolled in the study related to their sociodemographic status.



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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Our study aimed to prevent hypertensive disorders of pregnancy. So only female can be enrolled in the study as participant due to their ability to be pregnant
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • High risk pregnancy
  • At 12-16 weeks of gestation
  • Aged between 15 to 50 years
  • Living in Matlab bangladesh

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858595


Contacts
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Contact: Syed Imran Ahmed, MPH (+88 02) 9827001-10 ext 2216 syed.ahmed@icddrb.org
Contact: S. M. Tafsir Hasan, MBBS (+88 02) 9827001-10 ext 2216 tafsir.hasan@icddrb.org

Locations
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Bangladesh
Icddr,B Recruiting
Chandpur, Bangladesh
Contact: Salam Khan         
Sub-Investigator: Tahmeed Ahmed, PhD         
Sub-Investigator: Md Alfazal Khan, PhD         
Sub-Investigator: Md Shafiqul Alam Sarkar, PhD         
Sub-Investigator: S. M. Tafsir Hasan, MBBS         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Salu Design Group
Publications:
Jahan M, Hasanuzzaman M, Mahbuba S, Jahan H, Chowdhury S, Ahsan GU, et al. [225-POS]: Prevalence of preeclampsia in pre-gestational diabetic pregnancy in Bangladeshi patients. Pregnancy Hypertension: An International Journal of Women's Cardiovascular Health. 2015;5(1):113-4.
Preeclampsia Foundation [cited 2018 1st April]. Available from: https://www.preeclampsia.org/health-information/faqs
Arza A, Lázaro J, Gil E, Laguna P, Aguiló J, Bailon R, editors. Pulse transit time and pulse width as potential measure for estimating beat-to-beat systolic and diastolic blood pressure. Computing in Cardiology Conference (CinC), 2013; 2013: IEEE.
Wu C-M, Chuang CY, Chen Y-J, Chen S-C. A new estimate technology of non-invasive continuous blood pressure measurement based on electrocardiograph. Advances in Mechanical Engineering. 2016;8(6):1687814016653689.
General Economics Division (GED). Bangladesh Planning Commission. (2015). Millennium Development Goals: Bangladesh Progress Report 2015. Available from: http://www.plancomm.gov.bd/wp-content/uploads/2015/09/MDGs-Bangladeh-Progress-Report_-PDF_Final_September-2015.pdf. 2015
NIPORT. Bangladesh Maternal Mortality and Health Care Survey 2016. 2016;Preliminary report.
How to measure Blood Pressure. BP Measurement. British and Irish Hypertension Society. https://bihsoc.org/resources/bp-measurement/measure-blood-pressure/. 2017.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03858595    
Other Study ID Numbers: PR-18026
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Eclampsia,
Pre-Eclampsia
Low birthweight
Wearable
continuous monitoring
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
Essential Hypertension
Birth Weight
Weight Gain
Gestational Weight Gain
Vascular Diseases
Cardiovascular Diseases
Body Weight
Body Weight Changes
Pregnancy Complications