PREMOM II: Pregnancy Remote Monitoring of Women With Gestational Hypertensive Disorders (PREMOM II)

• ClinicalTrials.gov Identifier: NCT04031430
• Recruitment Status: Recruiting
• First Posted: July 24, 2019
• Last Update Posted: May 27, 2020
• Sponsor: Hasselt University
• Collaborators: Ziekenhuis Oost-Limburg; Universitaire Ziekenhuizen Leuven; AZ Sint-Jan AV; AZ Sint-Lucas Brugge; University Hospital, Antwerp
• Information provided by (Responsible Party): Wilfried Gyselaers, Hasselt University

Tracking Information

• First Submitted Date: November 21, 2018
• First Posted Date: July 24, 2019
• Last Update Posted Date: May 27, 2020
• Actual Study Start Date: June 18, 2019
• Estimated Primary Completion Date: April 14, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 22, 2019)

• Gestational age (GA) [ Time Frame: Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation. ]
  Throug study completion
• hospitalization [ Time Frame: Numbers of hospitalization during pregnancy (Numeric. Available by hospital details of every patient who is included in the study. From the moment of hospitalization until the moment of discharge is 1 hospitalization. ]
  Through study completion, from 32 weeks of gestation untill 34 weeks of gestation.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 22, 2019)

• number of prenatal consults [ Time Frame: through study completion, ]
  prenatal follow- up, numeric value, every consult during pregnancy from the first consultation until delivery
• number of ultrasounds [ Time Frame: through study completion ]
  numeric value, every ultrasound during pregnancy from the first consultation until delivery
• number of CTG's [ Time Frame: through study completion ]
  numeric value, every CTG during pregnancy from the first consultation until delivery
• number of hospitalizations of the mother at the MIC department [ Time Frame: through study completion ]
  numeric value, every hospitalization at the MIC during pregnancy from the first consultation until delivery
• number of days admitted to the MIC [ Time Frame: through study completion ]
  numeric value, amount of days admitted to the MIC from the first consultation unitil delivery
• number of medication adaptations during pregnancy [ Time Frame: through study completion ]
  numeric value, every change from no medication intake/a specific medciation at a specific dose to another medication intake at a specific dose.
• development of gestational hypertensive disorders [ Time Frame: through study completion ]
  numeric, the diagnoses of gestational hypertension/pre-eclampsia/HELLP during pregnancy
• Onset of delivery [ Time Frame: through study completion ]
  categorical (spontaneous, induced, primary section)
• Onset of delivery [ Time Frame: through study completion ]
  categorical (spontaneous, induced, primary section) from birth until discharge from the hospital
• Mode of delivery [ Time Frame: through study completion ]
  categorical (vaginal, instrumental, primary/secondary section) from birth until discharge from the hospital
• Birthweight [ Time Frame: through study completion ]
  gram from birth until discharge from the hospital
• Apgar at 1' and 5' [ Time Frame: through study completion ]
  numeric (0-10) from birth until discharge from the hospital
• Admission to the neonatal intensive care (NIC) [ Time Frame: through study completion ]
  categorical(Yes/no) from birth until discharge from the hospital
• Number of days admitted to the NIC [ Time Frame: through study completion ]
  numeric value, amount of days admidtted to the NIC, from birth until discharge from the hospital
• Cost for the health care services (HCS) [ Time Frame: through study completion ]
  Costs of the prenatal care as described in Secondary outcomes (1) and costs for the care during and after the delivery as described in Secondary outcomes (2), which are divided in: costs for the HCS, costs for the patient, costs for the RIZIV. All costs will be collected in Euros. rom the first contact with the gynaecologist until the discharge from the hospital of both the mother and the neonate.
• number of phone calls from the patient to the midwife for technical issues [ Time Frame: through study completion ]
  numeric scale, contributor to the added value of TM
• number of phone calls from the patient to the midwife for medical issues [ Time Frame: through study completion ]
  numeric scale, contributor to the added value of TM
• number of phone calls from the midwife to the patient for technical issues [ Time Frame: through study completion ]
  numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery
• number of phone calls from the midwife to the patient for medical issues [ Time Frame: through study completion ]
  numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery
• number of starts/adjustments to the antihypertensive medication [ Time Frame: through study completion ]
  numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PREMOM II: Pregnancy Remote Monitoring of Women With Gestational Hypertensive Disorders
• Official Title: PREMOM II: Pregnancy Remote Monitoring of Women With Gestational Hypertensive Disorders
• Brief Summary: The goal of this project is thoroughly evaluate the added value of telemonitoring (TM) program for women at risk for gestational hypertensive disorders (GHD), by investigating it impact on prenatal follow-up, health outcomes for mother and child, costs and satisfaction, and by specifically investigating what are the major contributors to this added value.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Gestational Hypertension

Intervention

Device: Telemonitoring

Women who are allocated to the PSM groep, will receive a connected blood pressure monitor. They have to measure their blood pressure twice a day and fill in their weight once a week in the App. These data are automatically transmitted via Bluetooth and Wi-Fi to the hospital, but the caregiver will not see those data, and can not react to it.

Study Arms

• Experimental: telemonitoring group (TM)
  Intervention: Device: Telemonitoring
• Active Comparator: Patient self-monitoring group (PSM)
  Intervention: Device: Telemonitoring
• No Intervention: control group (CC)

Publications *

• Lanssens D, Thijs IM, Gyselaers W; PREMOM II - consortium. Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders. BMC Pregnancy Childbirth. 2020 Oct 15;20(1):626. doi: 10.1186/s12884-020-03291-2.
• Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8:CD012739. doi: 10.1002/14651858.CD012739.pub2.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 22, 2019): 6107
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 14, 2023
• Estimated Primary Completion Date: April 14, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

- a risk > 1/100 on the Fetal Medicine Foundation (FMF) tool, which is used from the following website: https://fetalmedicine.org/research/assess/preeclampsia/first-trimester

Exclusion Criteria:

• congenital malformations of the newborn,
• pregnant women who doesn't have a Smartphone,
• pregnant women < 18 years old,
• pregnant women who doesn't understand the Dutch/French/English language. -

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Wilfried Gyselaers, prof. dr.; + 32 89 32 15 57; wilfried.gyselaers@zol.be

Contact: Dorien Lanssens, dr.; + 32 89 32 15 57; dorien.lanssens@uhasselt.be

• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT04031430
• Other Study ID Numbers: PREMOM II
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Wilfried Gyselaers, Hasselt University
• Study Sponsor: Hasselt University

Collaborators

• Ziekenhuis Oost-Limburg
• Universitaire Ziekenhuizen Leuven
• AZ Sint-Jan AV
• AZ Sint-Lucas Brugge
• University Hospital, Antwerp

Investigators

• Principal Investigator: Wilfried Gyselaers, prof. dr.; Hasselt University
• Study Chair: Dorien Lanssens, dr.; Hasselt University

• PRS Account: Hasselt University
• Verification Date: May 2020