Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies

Preterm Birth Clinical Trial

— NIEM-O  

Official title:

Non-invasive Electrophysiological Monitoring in High Risk Pregnancies at the Obstetric High Care: the NIEM-O Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151613
• Other study ID #: NL82869.015.22
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: November 20, 2025

Study information

• Verified date: December 2023
• Source: Maxima Medical Center
• Contact: ND de Klerk, MD
• Phone: +40 8888384
• Email: nadine.de.klerk[@]mmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this single centre cohort intervention study with historical controls, is to investigate the effect of implementing continuous antepartum electrophysiological CTG (eCTG) monitoring at the Obstetric High Care (OHC), on perinatal and maternal outcomes and obstetric care.

The main aim is to investigate the effect of both monitoring methods on:

• primary outcome: perinatal outcomes (a composite of perinatal mortality or major neonatal morbidity) until hospital discharge

• secondary outcomes: Maternal mortality, neonatal morbidity, satisfaction for both patient and caregiver, duration of pregnancy, switch of monitoring method, duration of admission to the OHC, timing (planned or emergency) and number of obstetric interventions (such as caesarean section), and admission and duration of admission to the NICU (neonatal intensive care unit).

Eligible women will be prospectively included in the cohort receiving standard treatment: CTG monitoring intermittent up to three times a day. From these eligible women, a random sample (464) of the prospective cohort (511) will be offered to receive a new monitoring method: 24/7 eCTG monitoring. In order to strengthen the comparison between the two groups (eCTG and standard treatment), additional data from 1400 women who received standard treatment in 2014-2019 will be collected retrospectively.

Description:

Pregnant women in need for maternal and/or fetal monitoring are hospitalized at the obstetric high care (OHC) of Máxima Medical Center (MMC). They are monitored for up to three times a day with conventional cardiotocography (CTG). In the meantime they reside at the OHC, but the status of the fetus and uterine activity (UA) is not monitored. Nemo Healthcare developed a wireless abdominal electrode patch for measuring fetal heart rate (FHR) and UA: The Nemo Fetal Monitoring System (NFMS). Previous research on non-invasive electrophysiological CTG (eCTG) has yielded promising results in monitoring FHR and UA both during pregnancy and labor. With the use of eCTG technology, safe continuous 24/7 monitoring is possible, which is not possible with conventional cardiotocography. The investigators hypothesize that by introducing continuous antepartum eCTG monitoring perinatal and maternal outcomes will improve.

The investigators aim to include 1911 pregnant women ≥18 years old with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalization on the OHC for maternal or fetal surveillance (including 1400 historical controls).

Additional objectives: The collected NFMS and demographic data will be used to develop and verify a mathematical model for the prediction of time until (preterm) birth, which may be used in clinical practice to reduce unnecessary OHC admissions and facilitate a better timing of interventions. Furthermore, data collected in this study (NFMS, accelerometric, annotated ultrasound) will be used for the development and verification of a mathematical model for the automated detection of fetal movements in NFMS data. This latter model might provide new opportunities in non-invasive monitoring of fetal health.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1911
• Est. completion date: November 20, 2025
• Est. primary completion date: November 20, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years old

• Singleton pregnancy =23+0 weeks of gestation

• Requiring hospitalization to the OHC for maternal or fetal surveillance (i.e. imminent preterm delivery(PPI), PE, HELLP, pregnancy induced hypertension (PIH), FGR, fetal distress, vaginal blood loss, fetal congenital anomalies)

• Parents wishing for fetal monitoring

Exclusion Criteria:

• Multiple pregnancy

• Insufficient knowledge of Dutch or English language

• Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)

• Women connected to an external or implanted electrical stimulator (e.g. a pacemaker - exclusion due to possible signal interference)

• Fetal and/or maternal cardiac disease (i.e. arrhythmia, congenital defect)

• Treatment plan (with intervention planned within 24 hours after admission) already made before inclusion is completed

• Women admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).

Related Conditions & MeSH terms

• High Risk Pregnancy
• Perinatal Outcomes
• Premature Birth
• Preterm Birth

Intervention

Device:
• continuous eCTG monitoring using the NFMS
Eligible women will be prospectively included in the cohort receiving standard treatment: CTG monitoring intermittent up to three times a day. From these eligible women, a random sample (464) of the prospective cohort (511) will be offered to receive a new monitoring method: 24/7 eCTG monitoring with NFMS. In order to strengthen the comparison between the two groups (eCTG and standard treatment), additional data from 1400 women who received standard treatment in 2014-2019 will be collected retrospectively.

Locations

Country	Name	City	State
Netherlands	Maxima Medical Centre	Veldhoven	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Maxima Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of perinatal mortality and major neonatal morbidity	A composite outcome consisting of: 1. Incidence of perinatal mortality and/or 2.Incidence of a major neonatal morbidity (defined as either: Intraventricular hemorrhage (IVH) grade three or more, Periventricular leukomalacia (PVL) grade two or more, Moderate or severe bronchopulmonary dysplasia (BPD), Necrotizing enterocolitis (NEC) grade two or more, or Retinopathy of prematurity (ROP) necessitating laser therapy).	during admission (immediately after birth until hospital discharge) or until at least 4 weeks after birth
Secondary	Incidence of maternal mortality	Incidence of maternal mortality in percentages	From moment of inclusion until six weeks after giving birth
Secondary	Incidence of neonatal morbidity	Incidence of other neonatal morbidity then described in the primary outcome (i.e. IVH grade 1-2, PVL grade 1, mild BPD, NEC grade 1, ROP not necessitating laser therapy, hypoxic ischemic encephalopathy, neonatal seizures, neonatal sepsis (culture proven), need for intubation on the delivery room, mechanical ventilation within the first 72 hours after birth, antibiotics within the first 72 hours after birth, spontaneous intestinal perforation (SIP) necessitating surgery, surfactant treatment, Apgar score <7 after 5 minutes, severe metabolic acidosis (pH <7.05 and base deficit =12mmol/L).	From inclusion assessed up to 6 months after inclusion
Secondary	Assesment using a surveys (D-QUEST) to measure patient satisfaction	Patient satisfaction of the given monitoring method, measured using a surveys: D-QUEST (comprises twelve items with a 5-point rating system. A high level of satisfaction is correlated with a high D-QUEST score, (Score between 14 and 70). The questionnaire is given ones to the patient during the trial.	At discharge, assessed up to 1 month.
Secondary	Assesment using a survey (EQ5D5L) to measure patient satisfaction	Patient satisfaction of the given monitoring method, measured using a survey: EQ5D5L (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 five 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 ones to the patient during the trial.	EQ5D5L questionnaire is given on day 1 of the admission (day 1 after inclusion). and assessed up to 1 month.
Secondary	Assesment using one survey (Browns survey) to measure caregiver satisfaction	Caregiver satisfaction is measured using Browns survey: purpose of this survey is to assess obstetricians' and midwives' use of current fetal-monitoring techniques and their views towards continuous monitoring, using multiple choice options (ranging from strongly agree to strongly disagree).	Caregivers are invited to fill in the questionnaire at baseline and at 1 year
Secondary	Duration of pregnancy in days	Duration of pregnancy measured in days	Measured from first day of pregnancy until birth, pregnancy period must be related to pregnancy at time of inclusion in the study. Assessed up to 5,5 months after inclusion.
Secondary	Switch of monitoring method from eCTG to CTG monitoring	Percentage of participants in which a switch is made from eCTG to CTG monitoring	From inclusion assessed up to 6 months after inclusion
Secondary	Duration of admission to the Obstetric High Care in days	Duration of admission to the Obstetric High Care measured in days	From inclusion assessed up to 6 months after inclusion
Secondary	Timing of obstetric interventions (caesarean section)	Planned or emergency caesarean section	From inclusion assessed up to 6 months after inclusion
Secondary	Number of obstetric interventions (caesarean section)	Number of obstetric intervention is measured as number of caesarean sections	From inclusion assessed up to 6 months after inclusion
Secondary	Admission (yes/no) to the NICU (neonatal intensive care unit)	Admission to NICU is qualified as yes or no	From inclusion assessed up to 6 months after inclusion
Secondary	Duration of admission to the NICU (neonatal intensive care unit) in days.	Duration of admission to the NICU (neonatal intensive care unit) is measured in days.	From inclusion assessed up to 6 months after inclusion