Please select the arm or intervention descriptions that belong to the clinical trial below.
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.

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.


Options:
A: Arm Label: Arm A: Conical then Cylindrical; Type: EXPERIMENTAL; Interventions: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Device: Non-invasive BP recording with traditional cylindrical BP cuff, Other: Direct invasive arterial pressure | Arm Label: Arm B: Cylindrical then Conical; Type: ACTIVE_COMPARATOR; Interventions: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Device: Non-invasive BP recording with traditional cylindrical BP cuff, Other: Direct invasive arterial pressure | Intervention Type: DEVICE; Name: Non-invasive BP recording with conical Ultracheck Curve BP cuff; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical | Intervention Type: DEVICE; Name: Non-invasive BP recording with traditional cylindrical BP cuff; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical | Intervention Type: OTHER; Name: Direct invasive arterial pressure; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical
B: Arm Label: Intervention Arm; Type: EXPERIMENTAL; Interventions: Other: Community-based Pre-eclampsia/Eclampsia Detection and Management, Other: Strengthened Referral Network from Community to Referral hospital levels | Arm Label: Enhanced Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Community-based Pre-eclampsia/Eclampsia Detection and Management; Assigned to Arm(s): Intervention Arm | Intervention Type: OTHER; Name: Strengthened Referral Network from Community to Referral hospital levels; Assigned to Arm(s): Intervention Arm
C: Arm Label: Mercury; Type: NO_INTERVENTION; Interventions: Device: Automated blood pressure recording device Omron HEM 705CP | Intervention Type: DEVICE; Name: Automated blood pressure recording device Omron HEM 705CP; Assigned to Arm(s): Mercury
D: Arm Label: telemonitoring group (TM); Type: EXPERIMENTAL; Interventions: Device: Telemonitoring | Arm Label: Patient self-monitoring group (PSM); Type: ACTIVE_COMPARATOR; Interventions: Device: Telemonitoring | Arm Label: control group (CC); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: CAPROM - Group 1; Type: EXPERIMENTAL; Interventions: Other: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication | Arm Label: CAPROM - Group 2; Type: EXPERIMENTAL; Interventions: Other: CV profiling before and after the start/switch of antihypertensive medication | Intervention Type: DEVICE; Name: Telemonitoring; Assigned to Arm(s): Patient self-monitoring group (PSM), telemonitoring group (TM) | Intervention Type: OTHER; Name: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication; Assigned to Arm(s): CAPROM - Group 1 | Intervention Type: OTHER; Name: CV profiling before and after the start/switch of antihypertensive medication; Assigned to Arm(s): CAPROM - Group 2

Answer: D