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NCT Number: NCT04031430

PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders

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.

A substudy (CAPROM) will be conducted at the Department of Obstetrics & Gynecology at Ziekenhuis Oost-Limburg (ZOL) in collaboration with the Department of Physiology of Hasselt University in the framework of the Limburg Clinical Research Center (LCRC). CAPROM aims at evaluating the relationship between longitudinal (clinical) blood pressure measurements and changes in (subclinical) cardiovascular (CV) hemodynamics throughout pregnancy, as well as their responses to antihypertensive medication. To this end, CV profiling will be performed longitudinally on pregnant women at risk for developing GHD being included in the TM group of the PREMOM II study (group 1) or being followed-up via TM as part of their usual care (group 2). A separate ICF is signed for inclusion in the CAPROM substudy. The results of the CAPROM study will be performed by a researcher who is not involved in the PREMOM II main study. In addition, results of the CV profiling will not be communicated to the clinical decision makers of PREMOM II.

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Key information

Conditions

Gestational Hypertension Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Antwerp, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • CAPROM substudy: Pregnant women at risk for the development of GHD being followed-up via TM as part of the PREMOM II study (group 1) or usual care (group 2)

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. -

Treatment and study plan

Telemonitoring

Device

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.

Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication

Other

Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication Registration of medication usage in the Medisafe app Assessment of their beliefs about medicine in general and during pregnancy and their perceptions regarding medication adherence by means of the 'Beliefs about Medicine Questionnaire' and the 'Probabilistic Medication Adherence Scale' at baseline and postpartum.

CV profiling before and after the start/switch of antihypertensive medication

Other

CV profiling before and after the start/switch of antihypertensive medication Registration of medication usage in the Medisafe app Assessment of their beliefs about medicine in general and during pregnancy and their perceptions regarding medication adherence by means of the 'Beliefs about Medicine Questionnaire' and the 'Probabilistic Medication Adherence Scale' at baseline and postpartum.

Primary outcomes

  1. Gestational age (GA)

    Time frame: Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation.

    difference of at least 10 days between the TM group and the CC was observed in our pilot studies, and will be used as a clinically relevant difference. An extension of the GA by even one day has a large impact on clinical outcomes for the neonate (both short- as long term). Moreover, the highest cost reductions were obtained in the group that delivered before 34 weeks of GA.

  2. hospitalization

    Time frame: From 32 weeks of gestation until 34 weeks of gestation

    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.

  3. Changes in CV physiological parameters - electrocardiogram (ECT) with Doppler ultrasonography

    Time frame: Month 3 to month 9

    The CV profile assessment consists of a simple, non-invasive method using the ECG with Doppler ultrasonography providing information about arteries and veins

  4. changes in CV physiological parameters - impedance cardiography

    Time frame: Month 3 to month 9

    The CV profile assessment consists of a simple, non-invasive method using Impedance Cardiography using the Non-Invasive Continuous Cardiac Output (NICCOMO) monitor registering heart parameters

  5. changes in CV physiological parameters - bio impedance

    Time frame: Month 3 to month 9

    The CV profile assessment consists of a simple, non-invasive method using Bio-Impedance using the Maltron® Bioscan 920-II giving information about the fluid balance.

  6. Arterial parameters - pulse transit time

    Time frame: Month 3 to month 9

    The Pulse Transit Method (PTT) as a non-invasive means to track Blood Pressure over a short period of time

  7. Arterial parameters - pulsatility index

    Time frame: Month 3 to month 9

    Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance with the use of Doppler ultrasonography.

  8. Arterial parameters - resistivity index of the left and right arcuate arteries

    Time frame: Month 3 to month 9

    The arterial resistive index is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70.

  9. venous parameters - venous pulse transit time of the hepatic and left and right renal veins

    Time frame: Month 3 to month 9

    Maternal venous pulse transit times (VPTT) weredefined as the time interval (ms) between the maternalECG P-wave and corresponding Doppler A-wave, correctedfor the duration of the corresponding cardiac cycle

  10. venous parameters - hepatic vein impedance index

    Time frame: Month 3 to month 9

    ECG-Doppler parameters were impedance index at the level of hepatic veins (HVI) and renal interlobar veins (RIVI) together with venous pulse transit times (VPTT), as well as resistive and pulsatility index, and arterial pulse transit time (APTT) at the level of uterine arcuate arteries.

  11. venous parameters - left and right renal interlobar vein impedance indices

    Time frame: Month 3 to month 9

    ECG-Doppler parameters were impedance index at the level of hepatic veins (HVI) and renal interlobar veins (RIVI) together with venous pulse transit times (VPTT), as well as resistive and pulsatility index, and arterial pulse transit time (APTT) at the level of uterine arcuate arteries.

  12. systolic blood pressure

    Time frame: Month 3 to month 9

    systolic blood pressure (mmHg),

  13. diastolic blood pressure

    Time frame: Month 3 to month 9

    diastolic blood pressure (mmHg),

  14. Mean arterial blood pressure

    Time frame: Month 3 to month 9

    Mean arterial blood pressure (mmHg),

  15. Total body water

    Time frame: Month 3 to month 9

    Total body water (liters)

  16. extracellular water

    Time frame: Month 3 to month 9

    extracellular water (liters)

  17. intracellular water

    Time frame: Month 3 to month 9

    intracellular water (liters)

  18. ECW/ICW ratio

    Time frame: Month 3 to month 9

    ECW/ICW ratio

  19. stroke volume

    Time frame: Month 3 to month 9

    stroke volume (ml)

  20. hear rate (beats/min)

    Time frame: Month 3 to month 9

    hear rate (beats/min)

  21. cardiac output (l/min)

    Time frame: Month 3 to month 9

    cardiac output (l/min)

  22. velocity index (1/1,000/s)

    Time frame: Month 3 to month 9

    velocity index (1/1,000/s)

  23. acceleration index (1/100/s²)

    Time frame: Month 3 to month 9

    acceleration index (1/100/s²)

  24. total peripheral resistance (dyn·s·cm-5)

    Time frame: Month 3 to month 9

    total peripheral resistance (dyn·s·cm-5)

Secondary outcomes

  1. number of prenatal consults

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    prenatal follow- up, numeric value, every consult during pregnancy from the first consultation until delivery

  2. number of ultrasounds

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric value, every ultrasound during pregnancy from the first consultation until delivery

  3. number of CTG's

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric value, every CTG during pregnancy from the first consultation until delivery

  4. number of hospitalizations of the mother at the MIC department

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric value, every hospitalization at the MIC during pregnancy from the first consultation until delivery

  5. number of days admitted to the MIC

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric value, amount of days admitted to the MIC from the first consultation unitil delivery

  6. number of medication adaptations during pregnancy

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric value, every change from no medication intake/a specific medciation at a specific dose to another medication intake at a specific dose.

  7. development of gestational hypertensive disorders

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric, the diagnoses of gestational hypertension/pre-eclampsia/HELLP during pregnancy

  8. Onset of delivery

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    categorical (spontaneous, induced, primary section) from birth until discharge from the hospital

  9. Mode of delivery

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    categorical (vaginal, instrumental, primary/secondary section) from birth until discharge from the hospital

  10. Birthweight

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    gram from birth until discharge from the hospital

  11. Apgar at 1' and 5'

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric (0-10) from birth until discharge from the hospital

  12. Admission to the neonatal intensive care (NIC)

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    categorical(Yes/no) from birth until discharge from the hospital

  13. Number of days admitted to the NIC

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric value, amount of days admidtted to the NIC, from birth until discharge from the hospital

  14. Cost for the health care services (HCS)

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    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.

  15. number of phone calls from the patient to the midwife for technical issues

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric scale, contributor to the added value of TM

  16. number of phone calls from the patient to the midwife for medical issues

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric scale, contributor to the added value of TM

  17. number of phone calls from the midwife to the patient for technical issues

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery

  18. number of phone calls from the midwife to the patient for medical issues

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery

  19. number of starts/adjustments to the antihypertensive medication

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery

  20. Changes in CV profile throughout pregnancy and in response to medication

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    Changes in Cardiovascular profile throughout pregnancy and in response to medication

  21. BMQ questionaire

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    Beliefs about Medicine Questionnaire

  22. ProMAS Questionnaire

    Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks

    a Probabilistic Medication Adherence Scale

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

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

Registry information

Official study title

PREMOM II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders

Acronym: PREMOM-II

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2019
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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