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Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD)

RecruitingNAAges 18 Years - anyFemaleRutgers, The State University of New Jersey
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In plain words

What the trial is, and whether it could suit you

Hypertensive disorders during pregnancy (HDP) and gestational diabetes (GDM) are among the leading complications in pregnancy, significantly contributing to global maternal and fetal morbidity and mortality. (1,2,3) Effective management of HDP and GDM hinges on regular monitoring of blood pressure (BP) and blood glucose (BG) to ensure adequate control and timely interventions for maternal and fetal well-being. Telemonitoring offers a promising and cost-effective alternative by enabling pregnant individuals to monitor BP and BG at home and share real-time results with healthcare providers, facilitating informed clinical decision-making and timely interventions. Here the investigators propose to conduct a Hybrid Type II Effectiveness-Implementation Randomized Controlled Trial (RCT) to assess the effectiveness and evaluate the implementation of the MOM-HD (Mobile-based Obstetric Monitoring

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Pregnant women receiving antenatal care at RCT site * Diagnosed with one of the following: * Chronic hypertension (sustained systolic BP โ‰ฅ140 mm Hg and/or diastolic BP โ‰ฅ90 mm Hg, or on antihypertensive treatment before 20 weeks of gestation) * Gestational hypertension or preeclampsia without severe features (sustained systolic BP โ‰ฅ140 mm Hg and/or diastolic BP โ‰ฅ90 mm Hg after 20 weeks of gestation) * Gestational diabetes * Age 18 years or older * Access to a smartphone * Gestational age โ‰ค 34 weeks at enrollment * Able to read and write Exclusion Criteria: * Multifetal pregnancies * Apparent communication difficulties (e.g., hearing, speech, or cognitive impairments), as judged by research assistants * Unable to understand the Nepali language * Severe maternal illness or any condition that precludes active study participation (e.g., preeclampsia with severe features, eclampsia, HELLP syndrome, or other conditions requiring inpatient management) * Declines to provide informed consent
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What it tests

  • MOM-HD
  • Standard Care
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Where

3 sites
Nobel Medical College & Teaching Hospital
Biratnagar, Nepal
Dhulikhel Hospital
Dhulikhel, Nepal
Paropakar Maternity and Women's Hospital
Kathmandu, Nepal
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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