Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies

Number of eCTG measurements

Count of eCTG measurements, measured in numbers and percentages

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Number of days with eCTG measurements

Count of days with eCTG measurements, measured in numbers and percentages.

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Number of successful eCTG measurements

Count of eCTG measurements assessed successful\* at closure by healthcare professional, Success rate, qualified as yes or no measured in numbers and percentages of total. \*Successful eCTG including the following: 1. a minimum of 30 minutes eCTG registration; 2. an overall a maximum of 20% signal loss (minutes, seconds); 3. sufficient interpretability according to HCPs clinical interpretation, if not maximum extended until 90 minutes when reassuring but insufficient. The amount of signal loss will be calculated based on the CTG. Signal loss is defined as minutes without registration of the fetal heart rate

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Number of repeated eCTG measurements

Count of repeated eCTG measurements the same day because of reassuring but insufficient interpretability, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Number of switches of monitoring method from eCTG to conventional CTG monitoring, because of insufficient signal quality.

Count of participants in which a switch is made from eCTG to CTG monitoring because of insufficient signal quality of the eCTG measurement, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Switch from eCTG to conventional CTG because of maternal and/or fetal reason

Count of participants in which a switch is made from eCTG to CTG monitoring because of maternal and/or fetal reason, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Success rate of conventional CTG measurement after switch from eCTG

Count of successful\* CTG measurements after switch from eCTG based on same criteria as in eCTG monitoring, qualified as yes or no, measured in numbers and percentages of total. \*Successful eCTG including the following: 1. a minimum of 30 minutes eCTG registration; 2. an overall a maximum of 20% signal loss (minutes, seconds); 3. sufficient interpretability according to HCPs clinical interpretation, if not maximum extended until 90 minutes when reassuring but insufficient.

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Number of eCTG measurements prematurely closed

Count of eCTG measurements prematurely closed by healthcare professional before complying the criteria of a successful measurement, qualified as yes of no, measured in numbers and percentages of total.

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) up to time of delivery

Number of participants with irritation abdominal skin

Count of patients with abdominal skin irritation, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to 12 hours after removal last abdominal eCTG patch

Number of "unscheduled antenatal visits"

Count of antenatal "unscheduled antenatal visits", qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to 37 weeks of gestational age or (when earlier) to time of delivery

Duration of pregnancy at inclusion (days)

Duration of pregnancy at inclusion, measured in days.

Time frame: At inclusion

Maternal diagnosis at inclusion

Maternal diagnosis at inclusion

Time frame: At inclusion

Reason(s) for fetal monitoring at inclusion

Reason(s) for fetal monitoring (at least 2 times a week), at the moment of inclusion (eg. pre-eclampsia, fetal growth restriction, preterm prelabour rupture of membranes, recurred decreased fetal movements, other reason needing monitoring at least 2 times a week)

Time frame: At inclusion

Number of mothers admitted to the Intensive Care Unit

Count of mothers admitted to the Intensive Care Unit, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to 6 weeks post-delivery

Number of maternal mortality

Count of maternal mortality, qualified as yes or no, measured in number and percentage in total.

Time frame: Inclusion up to 6 weeks post-delivery

Number of participants with emergency and or secondary cesarean section

Count of participants with emergency and or secondary cesarean section, qualified as yes or no, measured in numbers and percentages in total.

Time frame: Inclusion up to childbirth (up to maximum 42 weeks of gestation)

Number of participants diagnosed with abruptio placentae

Count of participants diagnosed with abruptio placentae, qualified as yes or no, measured in numbers and percentage of total.

Time frame: Inclusion up to childbirth (up to maximum 42 weeks of gestation)

Number of participants diagnosed with eclampsia

Count of participants diagnosed with eclampsia, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to 6 weeks post-delivery

Number of participants diagnosed with HELLP syndrome

Count of participants diagnosed HELLP syndrome, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to 6 weeks post-delivery

Number of participants diagnosed with prolapse of the umbilical cord

Number of participants diagnosed with prolapse of the umbilical cord, qualified as yes or no, measured in numbers and percentage of total.

Time frame: Inclusion up to childbirth (up to maximum 42 weeks of gestation)

Composite of maternal morbidity

Composite score of maternal morbidity, measured in number and percentage of one or more of the following: (eg. Emergency/secondary caesarean section, postpartum hemorrhage (bloodloss \>1000ml), abruptio placentae, eclampsia, HELLP syndrome, prolapse umbilical cord, pulmonary- and/or deep venous thrombosis (combined), chorioamnionitis)

Time frame: Start pregnancy up to 6 weeks post-delivery

Number of perinatal mortality

Count of fetal mortality qualified as yes or no, measured in number and percentage in total. General definition perinatal mortality: The number of fetal death past 22 completed weeks (154 days) of gestation plus the number of deaths among live-born children up to seven completed days of life).

Time frame: Inclusion up to 7 completed days of life

Number of fetal mortality

Count of fetal death, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Inclusion up to childbirth (up to maximum 42 weeks of gestation)

Number of neonatal mortality

Count of neonatal mortality, qualified as yes or no, measured in numbers and percentages, after the seventh day up to 28 completed days of life.

Time frame: After the seventh day but before the 28th day of life

Duration of pregnancy at childbirth (days)

Duration of pregnancy at childbirth, measured in days.

Time frame: Start pregnancy up to childbirth (up to maximum 42 weeks of gestation)

Number of neonates with involvement of a pediatrician

Count of participants with involvement of pediatrician, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Childbirth up to 6 weeks post-delivery

Number op neonates with dysmaturity (birthweight <p3, p3-p10, <p10)

Count of participants with dysmaturity qualified as yes or no, measured in numbers and percentages of total. Based on birth weight, measured in grammes and percentiles. 1\. Below the 3th percentile; 2. From the 3th up to the 10th percentile; 3. Below 10th percentile.

Time frame: At childbirth (maximum 42 weeks of gestation)

Number of neonates with a congenital anomality

Count of neonates with a neonatal anomality diagnosed at childbirth, qualified as yes or no, measured in numbers and percentages of total.

Time frame: At childbirth

Number of neonates with hypoxic ischemic encephalopathy (HIE)

Count of neonates with a HIE, diagnosed at childbirth, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Childbirth up to 6 weeks post-delivery

Number of neonates with Neonatal Respiratory Distress Syndrome (RDS)

Count of neonates with RDS, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Childbirth up to 6 weeks post-delivery

Number of neonates with Meconium Aspiration Syndrome (MAS)

Count of neonates with MAS, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Childbirth up to 6 weeks post-delivery

Number of neonates with convulsions

Count of neonates with convulsions, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Childbirth up to 6 weeks post-delivery

Number of neonates with a Clinical Early Onset Sepsis (EOS)

Number of neonates with a clinical EOS\*, qualified as yes or no, measured in numbers and percentages of total. \*Clinical early onset is defined as clinical sepsis within the first 72 hours after childbirth with \> 3 days of antibiotics. Assessment from childbirth until the first 72 hours after childbirth. Or in case antibiotics later started (eg. on day 2-3) following \> 3 days of antibiotics, assessment will be up to 7 days.

Time frame: Childbirth up to the first 72 hours, or up to 7 days after childbirth

Number of neonates with confirmed early onset sepsis (EOS)

Count of neonates with confirmed Early Onset Sepsis (EOS) is defined as positive cultures of blood, cerebrospinal fluid, or urine from the first 72 hours after birth, qualified as yes or no, measured in numbers and percentages of total.

Time frame: Childbirth up to 6 weeks post-delivery

Number of neonates with an Apgar score at 5 minutes below 7

Count of neonates with an Apgar score below at 5 minutes, qualified as yes or no, measured in numbers and percentages of total. Apgar score (1-10) a higher score meaning a better outcome. An Apgar score of lower than 7 at 5 minutes after birth meaning a worse outcome and will be defined as asphyxia.

Time frame: 5 minutes after childbirth

Number of neonates with an umbilical cord blood pH <7.05

Count of neonates with an umbilical cord blood pH \<7.05, meaning a severe metabolic acidosis (pH \<7.05 and base deficit ≥12mmol/L), qualified as yes or no, and measured in numbers and percentages of total.

Time frame: Directly after childbirth

Number of neonates with neonatal asphyxia

Count of neonates with neonatal asphyxia, qualified as yes or no, measured in number and percentages of total. Comprised one or more of the following: 1. An Apgar score \<7 at 5 minutes (Apgar score (1-10) a higher score meaning a better outcome); 2. Umbilical cord blood pH \<7.05 directly after childbirth; An Apgar score of lower than 7 at 5 minutes and/or an umbilical cord blood pH \<7.05 after birth (combined) meaning a worse outcome and will be defined as asphyxia.

Time frame: Directly after childbirth up to 5 minutes after childbirth

Number of neonates admitted to the Neonatal Medium Care Unit (NMCU)

Count of neonates with admission to neonatal medium care unit, qualified as yes or no, measured in number and percentages of total.

Time frame: Childbirth up to 6 weeks after delivery

Number of neonatal morbidities (composite)

Count of participants with fetal morbidity comprised one or more of the following, qualified as yes or no, and measured in number and percentages of total. Dysmaturity (below 3th percentile, between 3th and 10th percentile, below 10th percentile), congenital anomalies, Apgar score \<7 at 5 minutes, umbilical cord blood pH \<7.05, asphyxia (Apgar score \<7 at 5 minutes and/or umbilical cord pH \<7.05 combined)

Time frame: Childbirth up to 6 weeks post-delivery

Number of neonates with at least one neonatal diagnosis (composite)

Count of neonates with at least one neonatal diagnosis (composite), qualified as yes or no, measured in number and percentages of total. Complying at least one of the following: (eg. intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), hypoxic ischemic encephalopathy, neonatal convulsions, neonatal sepsis (culture proven), needing antibiotics within the first 72 hours after birth, spontaneous intestinal perforation (SIP) necessitating surgery, surfactant treatment.

Time frame: Childbirth up to 6 weeks post-delivery

Number of neonates with the need for intubation and/or mechanical ventilation

Count of neonates with the need for intubation an/or mechanical ventilation within the first 72 hours after childbirth, qualified as yes or no, measured in number and percentages of total.

Time frame: Childbirth up to 72 hours after childbirth

Duration admission to the Neonatal Medium Care Unit (days)

Duration admission to neonatal medium care unit, measured in days.

Time frame: Childbirth up to 6 weeks after delivery

Number of neonates with an admission to the Neonatal Intensive Care Unit (NICU)

Count of neonates with the need of admission to NICU, qualified as yes or no, measured in number and percentages of total.

Time frame: Childbirth up to 6 weeks post-delivery

Duration of admission to the NICU (neonatal intensive care unit) in days.

Duration of admission to the NICU (neonatal intensive care unit), measured in days.

Time frame: Childbirth up to 6 weeks post-delivery

Assessment (twice) using a survey EuroQol including 5 dimensions and 5 levels (EQ5D-5L) to measure patient wellbeing, including visual analog pain scale (VAS)

Patient wellbeing of the given monitoring method, measured using EQ5D-5L a survey: This assessment tool assigns a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and the summing of these values across the 5 items, results in a score. The score is then placed on a scale, which is numbered from 0 to 100. 100 means the best health one can imagine. 0 means the worst health one can imagine. The questionnaire is given twice to the patient during the trial. VAS: This assessment tool assigns a score between 0 and 100 - indicating their overall health will be summarized. A higher score meaning a better health.

Time frame: At inclusion and at 4 weeks post-delivery

Assessment (once) using a surveys (D-QUEST) to measure patient satisfaction of the received monitoring method (device)

Patient satisfaction of the given monitoring method (device), measured using a survey, given once to the patient during the trial. Questionnaire comprises 12 items that can influence the users' satisfaction of a device and the provision process with a 5-point rating system and 2 composite items with a 5-point rating system. Total score range from 14 to 70, with the higher number indicating greater satisfaction. 5-point rating: not satisfied at all (1), displeased (2), more or less satisfied (3), satisfied (4) or very satisfied (5). Personal additional information can be given in a free description space. Patients are asked to underline the 3 most important aspects of the questionnaire.

Time frame: At discharge from the hospital, at 37 weeks of gestational age or (when earlier) post-delivery

Assessment (once) using a survey (CSQ-8) to measure patient satisfaction of the overall received care

Client/patient satisfaction of the overall received care, measured using a survey, given once to the participants, at 4 weeks post-delivery. CSQ-8: comprises 8 items including scores from 1 to 4. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Time frame: At 4 weeks post-delivery

Assessment (once) using a survey (D-Quest) to measure Healthcare professional (HCP) satisfaction of the given monitoring method.

HCP satisfaction of the given monitoring method (device), measured using a survey: Questionnaire comprises 12 items that can influence the HCP' satisfaction of a device and the provision process with a 5-point rating system and 2 composite items with a 5-point rating system. Total score range from 14 to 70, with the higher number indicating greater satisfaction. 5-point rating: not satisfied at all (1), displeased (2), more or less satisfied (3), satisfied (4) or very satisfied (5). Personal additional information can be given in a free description space. HCP are asked to underline the 3 most important aspects of the questionnaire. The D-Quest survey is based on a validated patient questionnaire and suitable for HCPs after minimal adjustments. HCP will receive the survey once, at the moment when the last participant has delivered or has reached the gestational age of 37 weeks.

Time frame: At the moment when the last participant has delivered or has reached the gestational age of 37 weeks, assessed up to 1 month.d

Antenatal costs as a business case model

To assess the costs (euro) of remote home monitoring versus in-hospital monitoring, patient journeys will be followed and costs calculated (N,n, Euro) as if they were at home using remote eCTG compared to in- hospital standard care using conventional CTG. (eg. eCTG, CTG, admission day, visits, emergency ambulance rides) The patient journey will not depend on participation in the HASTA study but is part of the standard care and HCP decision. Total of costs: mean and median (euro) and the percentage (%) of patients with at least one registered activity (% treated). In addition, a sub-analysis will be presented of participants needing hospitalization and of participants monitoring at the outpatient clinic at inclusion.

Time frame: Inclusion up to moment of start delivery (antenatal period), assessed up to maximum 42 weeks of gestation.