NCT07243886: MOM-HD

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

Not yet recruiting NA Last updated 3 December 2025

What this trial tests

NA trial testing MOM-HD in Gestational Diabetes in 864 participants. Not yet recruiting.

Timeline

1 September 2026

Primary endpoint
28 February 2030

31 December 2030

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	864
Start date	1 September 2026
Primary completion	28 February 2030
Estimated completion	31 December 2030

Drugs / interventions tested

• MOM-HD
• Standard Care — full drug profile →

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →
• Hypertensive Disorder of Pregnancy — all drugs for Hypertensive Disorder of Pregnancy →

Sponsor

Rutgers, The State University of New Jersey

Who can join

18 and older, female only, with Gestational Diabetes or Hypertensive Disorder of Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 for Hypertension and/or Diabetes) program, a mobile app-based perinatal telemonitoring program, in real-world clinical settings in Nepal. To address the study aims, the investigators will recruit 864 women who are newly diagnosed with HDP and GDM from three metropolitan hospitals and randomly assign them to either (i) MOM-HD + standard care or (ii) standard care alone, from enrolment in pregnancy to 6 weeks postpartum. Primary and secondary clinical outcomes will be assessed at delivery, and at 6 weeks postpartum. The investigators hypothesize that compared to standard care, the use of MOM-HD in addition to standard care will result in lower systolic BP levels, lower incidence rate for the composite adverse perinatal outcome of either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery or labor induction, and lower proportion of days with elevated systolic BP or BG readings between recruitment and 6 weeks postpartum. A convergent mixed-methods approach will be used to assess implementation and maintenance outcomes using the RE-AIM framework (4), and economic sustainability will be assessed by collecting primary cost data.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.