Perinatal OutcomesNIEM-ONCT06151613
Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies
A study testing continuous eCTG monitoring using the NFMS in people with Perinatal Outcomes and Preterm Birth, run by Maxima Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Outcomes, Preterm Birth, High Risk Pregnancy
- What is being tested?
- continuous eCTG monitoring using the NFMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,911 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Nov 2023to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maxima Medical Centre
Veldhoven, North Brabant, 5504DB
ND de Klerk, MD, +31 40 8888384, nadine.de.klerk@mmc.nl
About this study
Official title: Non-invasive Electrophysiological Monitoring in High Risk Pregnancies at the Obstetric High Care: the NIEM-O Study
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Perinatal Outcomes, Preterm Birth, High Risk Pregnancy
- Being tested
- continuous eCTG monitoring using the NFMS
- Keywords
- Electrophysiological monitoring, Cardiotocography, Antepartum monitoring, continuous monitoring, Non-invasive fetal monitoring
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous eCTG monitoring using the NFMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous eCTG monitoring | Active comparator | For the continuous eCTG monitoring, a wireless abdominal electrode patch (measuring fetal heart rate (FHR) and uterine activity (UA)) is used, developed by Nemo Healthcare: The Nemo Fetal Monitoring System (NFMS).
The advantage of the NFMS is that is a safe method for continuous (24/7) fetal monitoring. Furthermore, the patch does not have to be repetitively repositioned during registration, it can be used under the shower and it is wireless giving women more freedom to move around freely. Another benefit of eCTG monitoring is that it is especially suited for women with obesity, where conventional CTG monitoring often fails Receives: Device: continuous eCTG monitoring using the NFMS |
| Conventional intermittent CTG monitoring | No intervention | Conventional intermittent CTG monitoring is performed in Maxima Medical Centre by the use of Philips Avalon FM 30 (Philips Healthcare, Eindhoven, The Netherlands). This is a combined external measurement method using two transducers placed on the maternal abdomen: one to measure fetal heart rate (FHR) by the use of Doppler ultrasound (DU) and the other at the fundus of the uterus to measure uterine activity (UA) pattern (TOCO), keeping them in place with elastic banding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: during admission (immediately after birth until hospital discharge) or until at least 4 weeks after birth
Secondary outcomes (12)
Incidence of maternal mortality
Incidence of maternal mortality in percentages
Measured: From moment of inclusion until six weeks after giving birth
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).
Measured: From inclusion assessed up to 6 months after inclusion
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.
Measured: At discharge, assessed up to 1 month.
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.
Measured: EQ5D5L questionnaire is given on day 1 of the admission (day 1 after inclusion). and assessed up to 1 month.
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).
Measured: Caregivers are invited to fill in the questionnaire at baseline and at 1 year
Duration of pregnancy in days
Duration of pregnancy measured in days
Measured: 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.
Switch of monitoring method from eCTG to CTG monitoring
Percentage of participants in which a switch is made from eCTG to CTG monitoring
Measured: From inclusion assessed up to 6 months after inclusion
Duration of admission to the Obstetric High Care in days
Duration of admission to the Obstetric High Care measured in days
Measured: From inclusion assessed up to 6 months after inclusion
Timing of obstetric interventions (caesarean section)
Planned or emergency caesarean section
Measured: From inclusion assessed up to 6 months after inclusion
Number of obstetric interventions (caesarean section)
Number of obstetric intervention is measured as number of caesarean sections
Measured: From inclusion assessed up to 6 months after inclusion
Admission (yes/no) to the NICU (neonatal intensive care unit)
Admission to NICU is qualified as yes or no
Measured: From inclusion assessed up to 6 months after inclusion
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.
Measured: From inclusion assessed up to 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start22 Nov 2023
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perinatal OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A single center prospective cohort intervention study with historical controls.
- Masking
- None (open label)
- Enrolment
- 1,911 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Nadine de Klerk, Maxima Medical Center
- Investigators
- SG Oei, Prof.dr., Principal investigator, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151613
- Sponsor's protocol ID
- NL82869.015.22
- Acronym
- NIEM-O
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
de Klerk ND, de Vries IR, Dieleman JP, Fransen AF, Oei SG. Intrapartum cardiotocographic patterns and perinatal outcomes in extremely preterm births: an exploratory retrospective cohort study. BMC Pregnancy Childbirth. 2026 Mar 27;26(1):494. doi: 10.1186/s12884-026-08954-0.
PubMed 41896782de Klerk ND, Berben PBQ, de Vries IR, Niemarkt H, Vullings R, van den Heuvel ER, van der Ven M, Fransen AF, Oei SG, van Laar JOEH. Continuous non-invasive electrophysiological monitoring in high-risk pregnancies: study protocol of a cohort intervention random sampling study in a tertiary obstetrical care centre in the Netherlands (NIEM-O study). BMJ Open. 2025 Nov 12;15(11):e102732. doi: 10.1136/bmjopen-2025-102732.
PubMed 41224309
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Electrophysiological Monitoring in High Risk Pregnancies at the Obstetric High Care: the NIEM-O Study
- ClinicalTrials.gov ID
- NCT06151613
- Acronym / sponsor ID
- NIEM-O / NL82869.015.22
- Conditions
- Perinatal Outcomes, Preterm Birth, High Risk Pregnancy
- Keywords
- Electrophysiological monitoring, Cardiotocography, Antepartum monitoring, continuous monitoring, Non-invasive fetal monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,911 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single center prospective cohort intervention study with historical controls.
| Arm | Type | Receives |
|---|---|---|
| Continuous eCTG monitoring | Active comparator | Device: continuous eCTG monitoring using the NFMSFor the continuous eCTG monitoring, a wireless abdominal electrode patch (measuring fetal heart rate (FHR) and uterine activity (UA)) is used, developed by Nemo Healthcare: The Nemo Fetal Monitoring System (NFMS). The advantage of the NFMS is that is a safe method for continuous (24/7) fetal monitoring. Furthermore, the patch does not have to be repetitively repositioned during registration, it can be used under the shower and it is wireless giving women more freedom to move around freely. Another benefit of eCTG monitoring is that it is especially suited for women with obesity, where conventional CTG monitoring often fails |
| Conventional intermittent CTG monitoring | No intervention | –Conventional intermittent CTG monitoring is performed in Maxima Medical Centre by the use of Philips Avalon FM 30 (Philips Healthcare, Eindhoven, The Netherlands). This is a combined external measurement method using two transducers placed on the maternal abdomen: one to measure fetal heart rate (FHR) by the use of Doppler ultrasound (DU) and the other at the fundus of the uterus to measure uterine activity (UA) pattern (TOCO), keeping them in place with elastic banding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous eCTG monitoring using the NFMSEligible 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. | Device | Continuous eCTG monitoring |
Primary outcome
Incidence of perinatal mortality and major neonatal morbidity
Time frame: during admission (immediately after birth until hospital discharge) or until at least 4 weeks after birth
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).
12 secondary outcomes
Incidence of maternal mortality
Time frame: From moment of inclusion until six weeks after giving birth
Incidence of neonatal morbidity
Time frame: From inclusion assessed up to 6 months after inclusion
Assesment using a surveys (D-QUEST) to measure patient satisfaction
Time frame: At discharge, assessed up to 1 month.
Assesment using a survey (EQ5D5L) to measure patient satisfaction
Time frame: EQ5D5L questionnaire is given on day 1 of the admission (day 1 after inclusion). and assessed up to 1 month.
Assesment using one survey (Browns survey) to measure caregiver satisfaction
Time frame: Caregivers are invited to fill in the questionnaire at baseline and at 1 year
Duration of pregnancy in days
Time frame: 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.
Switch of monitoring method from eCTG to CTG monitoring
Time frame: From inclusion assessed up to 6 months after inclusion
Duration of admission to the Obstetric High Care in days
Time frame: From inclusion assessed up to 6 months after inclusion
Timing of obstetric interventions (caesarean section)
Time frame: From inclusion assessed up to 6 months after inclusion
Number of obstetric interventions (caesarean section)
Time frame: From inclusion assessed up to 6 months after inclusion
Admission (yes/no) to the NICU (neonatal intensive care unit)
Time frame: From inclusion assessed up to 6 months after inclusion
Duration of admission to the NICU (neonatal intensive care unit) in days.
Time frame: From inclusion assessed up to 6 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 41896782de Klerk ND, de Vries IR, Dieleman JP, Fransen AF, Oei SG. Intrapartum cardiotocographic patterns and perinatal outcomes in extremely preterm births: an exploratory retrospective cohort study. BMC Pregnancy Childbirth. 2026 Mar 27;26(1):494. doi: 10.1186/s12884-026-08954-0.
- Derived from this study: PubMed 41224309de Klerk ND, Berben PBQ, de Vries IR, Niemarkt H, Vullings R, van den Heuvel ER, van der Ven M, Fransen AF, Oei SG, van Laar JOEH. Continuous non-invasive electrophysiological monitoring in high-risk pregnancies: study protocol of a cohort intervention random sampling study in a tertiary obstetrical care centre in the Netherlands (NIEM-O study). BMJ Open. 2025 Nov 12;15(11):e102732. doi: 10.1136/bmjopen-2025-102732.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SG Oei, Prof.dr. principal investigator
Maxima Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous eCTG monitoring using the NFMS in people with Perinatal Outcomes and Preterm Birth, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ND de Klerk, MD (+40 8888384, nadine.de.klerk@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perinatal mortality and major neonatal morbidity (time frame: during admission (immediately after birth until hospital discharge) or until at least 4 weeks after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06151613, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.