Please select the outcome measures that correspond 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: Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement (Single time point measurement (1 day))
B: Primary outcome (composite indicator reflecting activities associated with recognition and management/treatment of pre-eclampsia) (Outcome is evaluated at one month post delivery)
C: The primary maternal outcome measure was the number of women having any episode of severe hypertension (BP ³ 170/110mmHg).
D: Gestational age (GA) (Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation.); hospitalization (From 32 weeks of gestation until 34 weeks of gestation); Changes in CV physiological parameters - electrocardiogram (ECT) with Doppler ultrasonography (Month 3 to month 9); changes in CV physiological parameters - impedance cardiography (Month 3 to month 9); changes in CV physiological parameters - bio impedance (Month 3 to month 9); Arterial parameters - pulse transit time (Month 3 to month 9); Arterial parameters - pulsatility index (Month 3 to month 9); Arterial parameters - resistivity index of the left and right arcuate arteries (Month 3 to month 9); venous parameters - venous pulse transit time of the hepatic and left and right renal veins (Month 3 to month 9); venous parameters - hepatic vein impedance index (Month 3 to month 9); venous parameters - left and right renal interlobar vein impedance indices (Month 3 to month 9); systolic blood pressure (Month 3 to month 9); diastolic blood pressure (Month 3 to month 9); Mean arterial blood pressure (Month 3 to month 9); Total body water (Month 3 to month 9); extracellular water (Month 3 to month 9); intracellular water (Month 3 to month 9); ECW/ICW ratio (Month 3 to month 9); stroke volume (Month 3 to month 9); hear rate (beats/min) (Month 3 to month 9); cardiac output (l/min) (Month 3 to month 9); velocity index (1/1,000/s) (Month 3 to month 9); acceleration index (1/100/s²) (Month 3 to month 9); total peripheral resistance (dyn·s·cm-5) (Month 3 to month 9)

Answer: D