Fetal MonitoringNIEM-IINCT06135961
Intrapartum Non-invasive Electrophysiological Monitoring
A study testing eCTG monitoring with the NFMS in people with Fetal Monitoring and Non-invasive, run by Maxima Medical Center at 1 site in Netherlands.
Trial summary
Conventional cardiotocography (CTG) has been used extensively for more than 50 years to monitor the fetal condition during labour, but since the rate of operative deliveries keeps rising, its ability to improve neonatal outcomes is unsatisfactory. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Monitoring, Non-invasive, Cardiotocography
- What is being tested?
- eCTG monitoring with the NFMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,471 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Nov 2023to 15 Feb 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimal age of 18 years old
- Pregnant women with a gestational age between 37+0 and 42+0 weeks and days
- Indication for fetal monitoring during labour
- Singleton fetus in cephalic position
- Oral and written informed consent is obtained
Who cannot join
- Insufficient knowledge of Dutch or English language
- Women with a multiple pregnancy
- Fetal and/or maternal cardiac arrhythmias
- 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, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal)
- Women who take a bath for multiple times during delivery and/or who take a bath for > 1 hour during the first stage of labour and/or who take a bath in the second stage of labour. eCTG monitoring is impossible in bath because the Bluetooth signal is disturbed. In bath, monitoring will be performed by conventional CTG monitoring. However, it is possible to take a shower with eCTG monitoring
Show all 10Show fewer
- Treatment plan (with intervention plan) already made before inclusion is completed.
- Women who were included in the study, but when circumstances before labour call for delivery of the baby by unplanned caesarean section.
- There is insufficient time for proper counselling
- 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 MC
Veldhoven, North Brabant, 5504 DB
Phebe Berben, Medical Doctor, PhD Candidate, +3140 - 888 8000, phebe.berben@mmc.nl
Guid Oei, Professor
About this study
Official title: Implementation of Intrapartum Non-invasive Electrophysiological Monitoring
Conventional cardiotocography (CTG) has been used extensively for more than 50 years to monitor the fetal condition during labour, but since the rate of operative deliveries keeps rising, its ability to improve neonatal outcomes is unsatisfactory. A transabdominal non-invasive and wireless alternative which overcomes the shortcomings of conventional methods is electrophysiological CTG (eCTG) monitoring. In eCTG the fetal heart rate (FHR) is measured by fetal electrocardiography (NI-fECG) and uterine activity (UA) by electrohysterography (EHG). Both NI-fECG and EHG have been proven more accurate and reliable than conventional non-invasive methods and are less affected by maternal body mass index (BMI).
This study aims to evaluate the mode of delivery, maternal and perinatal outcomes, costs and patient and healthcare professionals perspectives on eCTG monitoring versus the conventional CTG during labour at term with a singleton fetus in cephalic position.
Read more
The eCTG provides a more accurate assessment of the fetus and the UA, compared to the conventional CTG. This allows for optimization of the contraction pattern during high-risk deliveries. We hypothesize that this will reduce the number of operative interventions and improves perinatal outcome. There are three reasons why an improvement in the contraction pattern by the eCTG can influence our outcomes:
- EHG can detect excessive UA more accurately. Increased UA is a major risk for fetal distress. In this case, stimulation with oxytocin should be reduced or stopped. More adequate interpretation of FHR, reduced tachysystole and reduced hypertonia is expected to result in fewer instrumented vaginal deliveries and a reduction of caesarean sections due to fetal distress.
- EHG can demonstrate unorganized UA that needs to be corrected with a higher dose of oxytocin to enhance contraction frequency and efficiency. This can result in a less exhausted uterine muscle, shorter time to delivery, less vacuum deliveries and caesarean sections due to failure of progress. A shorter time to delivery will also result in a reduction of infections and blood loss.
- Accurate registration of the relation between the contraction and decelerations of FHR, is expected to result in more reliable assessment of the fetal condition. This can result in fewer unnecessary operative deliveries and less unpredictable poor perinatal outcomes.
- Being tested
- eCTG monitoring with the NFMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCTG monitoring with the NFMSDevice
Device: Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| eCTG monitoring | Active comparator | eCTG monitoring with the Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands).
The NFMS consists of a wireless and beltless electrode patch on the maternal abdomen. It monitors fetal heart rate by fetal electrocardiography, maternal heart rate by maternal electrocardiography and the electrical activity of the uterine muscle by electrohysterography.
The advantage of the NFMS is that it is a safe method that can be used in all situations that are contraindicated for invasive monitoring. Furthermore, it can be used when the membranes are not ruptured and the patch does not have to be repetitively repositioned during labor. Because the NFMS is wireless, it gives women more freedom of movement during labor. Receives: Device: eCTG monitoring with the NFMS |
| Conventional CTG monitoring | No intervention | Philips Avalon FM 30 (Philips Healthcare, Eindhoven, the Netherlands). The fetal heart rate is measured non-invasively by doppler ultrasound or invasively by fetal scalp electrode. The uterine activity and maternal heart rate is measured by tocodynamometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of operative interventions during labor
cesarean section or instrumental vaginal delivery
Measured: During delivery
Secondary outcomes (35)
Duration of the first stage of labor in minutes
Measured: 0-10 cm dilation during labor
Duration of the second stage of labor in minutes
Measured: Start pushing until childbirth
The timing and reason of operative interventions during labor
Timing is defined as:
- The decision delivery interval for the intervention: emergency ('code red' or within <30 minutes of the decision) or ≥ 1 hour
- As the phase of delivery: first stage or second stage of labor
Measured: During delivery
The number of participants with analgesia for pain reduction: epidural or/and remifentanil
Measured: During delivery
Perineal laceration (grade 1, 2, 3a, 3b, 3c, 4)
Measured: Directly after childbirth
The number of participants with a mediolateral episiotomy and reason for the episiotomy
Measured: Directly after childbirth
Number (percentage) and result of fetal blood sampling during the primary and secondary stages of labour
Measured: During delivery
Perinatal mortality
Perinatal mortality is defined as the number of fetal deaths past 22 completed weeks (154 days) of gestation plus the number of deaths among live-born children up to seven completed days of life
Measured: During pregnancy up to seven completed days of life
Neonatal mortality
Neonatal mortality is defined as the number of neonatal deaths after the seventh day but before the 28th day of life
Measured: After the seventh day but before the 28th day of life
The number of neonates with hypoxic ischemic encephalopathy
Measured: childbirth - 28th day postpartum
The number of neonates with Neonatal Respiratory Distress Syndrome (RDS)
Measured: childbirth - 28th day postpartum
The number of neonates with Meconium Aspiration Syndrome (MAS)
Measured: childbirth - 28th day postpartum
The number of neonates with convulsions
Measured: childbirth - 28th day postpartum
The number of neonates with Clinical early onset sepsis
Clinical early onset is defined as clinical sepsis within the first 72 hours after birth with > 3 days of antibiotics
Measured: childbirth - 28th day postpartum
The number of neonates with Confirmed early onset sepsis
Confirmed early onset sepsis is defined as positive cultures of blood, cerebrospinal fluid, or urine from the first 72 hours after birth
Measured: childbirth - 72 hours after childbirth
The number of neonates with admission to Neonatal Intensive Care Unit
Measured: childbirth - 28th day postpartum
Length of Admission to Neonatal Intensive Care Unit
In days
Measured: childbirth - 28th day postpartum
Reason for the admission to Neonatal Intensive Care Unit
Measured: childbirth - 28th day postpartum
The number of neonates with the need for mechanical ventilation
The number of neonates with the need for mechanical ventilation within the first 72 hours after birth
Measured: childbirth - 72 hours after childbirth
The number of neonates with a 5 minute Apgar score <7
Measured: 5 minutes after childbirth
The number of neonates with a neonatal acidosis at birth
It is defined as cord artery pH < 7.05 and base deficit > 12 mmol/L directly after birth. The definition is set as pH < 7.10 and base deficit > 12 mmol/L in cases with only an umbilical vein sample (one available blood gas sample or the pH difference between two samples below 0.03)
Measured: Directly after childbirth
Maternal mortality
Maternal mortality or 'pregnancy-related death' is defined as death from any cause related to or aggravated by the pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy
Measured: During pregnancy and childbirth or within 42 days of termination of pregnancy
The number of mothers admitted to the Intensive Care Unit
Measured: childbirth until six weeks postpartum
The number of mothers with a thromboembolic event
Measured: childbirth until six weeks postpartum
The number of mothers with an uterine rupture
Measured: childbirth until six weeks postpartum
The number of mothers with an obstetric haemorrhage
Obstetric haemorrhage > 1000 millilitres within 24 hours after giving birth
Measured: childbirth until 24 hours after childbirth
The number of mothers with a postpartum anemia due to postpartum haemorrhage with requires red cell transfusion
Measured: childbirth until six weeks postpartum
The number of mothers with a suspected or confirmed postpartum infection requiring antibiotics
i.e. chorioamnionitis, endometritis, wound infection and/or urinary tract infection.
Measured: childbirth until six weeks postpartum
Patient satisfaction by questionnaires
Validated Birth-Satisfaction-Scale-Revised questionnaire and a non-validated questionnaire.
Measured: 2-6 hours after childbirth
Professional satisfaction by questionnaire
Non-validated questionnaire
Measured: 1 year after the start of the study
Costs as a business case model until six weeks postpartum
Measured: Delivery until six weeks postpartum
For eCTG monitoring: amount of signal loss in percentage of total duration during labour
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
Measured: During delivery
For eCTG monitoring: frequency of switch from Nemo Fetal Monitoring System to conventional CTG + reason, timing and success percentage of the switch
Measured: During delivery
For eCTG monitoring: EHG pattern within the first 1.5 hours postpartum and the possible association with the amount of bloodloss, medication use and time to placental expulsion
Measured: First 1.5 hours postpartum
For eCTG monitoring: EHG pattern before and after labour analgesia and the possible association of EHG pattern with labour analgesia
Measured: During delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Nov 2023
- Primary completion20 Nov 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal MonitoringStudies 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
- Eligible women will be prospectively included in the cohort receiving conventional CTG monitoring. From the eligible women in the prospective cohort a random sample (90.9%) will be offered eCTG monitoring via a computer generated random collection. Participants will receive eCTG monitoring from the start of fetal monitoring during labour until 1.5 hour after delivery. A retrospective cohort of 2100 women who received conventional CTG monitoring between April 2019 and February 2023 will be added to the prospective cohort for statistical analysis.
- Masking
- None (open label)
- Enrolment
- 3,471 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, Phebe Berben, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135961
- Sponsor's protocol ID
- NL82822.015.22
- Acronym
- NIEM-II
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2023
- Last updated
- 15 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
Berben PBQ, de Klerk ND, van der Ven M, Fransen AF, Niemarkt HJ, van den Heuvel ER, van der Hout-van der Jagt MB, Oei SG, van Laar JOEH. Non-invasive electrophysiological monitoring vs conventional monitoring during labour in a tertiary obstetric care centre in the Netherlands: study protocol of a cohort intervention random sampling study (NIEM-II study). BMJ Open. 2025 Jul 22;15(7):e102901. doi: 10.1136/bmjopen-2025-102901.
PubMed 40701589
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Intrapartum Non-invasive Electrophysiological Monitoring
- ClinicalTrials.gov ID
- NCT06135961
- Acronym / sponsor ID
- NIEM-II / NL82822.015.22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,471 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 18 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.
Conventional cardiotocography (CTG) has been used extensively for more than 50 years to monitor the fetal condition during labour, but since the rate of operative deliveries keeps rising, its ability to improve neonatal outcomes is unsatisfactory. A transabdominal non-invasive and wireless alternative which overcomes the shortcomings of conventional methods is electrophysiological CTG (eCTG) monitoring. In eCTG the fetal heart rate (FHR) is measured by fetal electrocardiography (NI-fECG) and uterine activity (UA) by electrohysterography (EHG). Both NI-fECG and EHG have been proven more accurate and reliable than conventional non-invasive methods and are less affected by maternal body mass index (BMI).
This study aims to evaluate the mode of delivery, maternal and perinatal outcomes, costs and patient and healthcare professionals perspectives on eCTG monitoring versus the conventional CTG during labour at term with a singleton fetus in cephalic position.
The eCTG provides a more accurate assessment of the fetus and the UA, compared to the conventional CTG. This allows for optimization of the contraction pattern during high-risk deliveries. We hypothesize that this will reduce the number of operative interventions and improves perinatal outcome. There are three reasons why an improvement in the contraction pattern by the eCTG can influence our outcomes:
- EHG can detect excessive UA more accurately. Increased UA is a major risk for fetal distress. In this case, stimulation with oxytocin should be reduced or stopped. More adequate interpretation of FHR, reduced tachysystole and reduced hypertonia is expected to result in fewer instrumented vaginal deliveries and a reduction of caesarean sections due to fetal distress.
- EHG can demonstrate unorganized UA that needs to be corrected with a higher dose of oxytocin to enhance contraction frequency and efficiency. This can result in a less exhausted uterine muscle, shorter time to delivery, less vacuum deliveries and caesarean sections due to failure of progress. A shorter time to delivery will also result in a reduction of infections and blood loss.
- Accurate registration of the relation between the contraction and decelerations of FHR, is expected to result in more reliable assessment of the fetal condition. This can result in fewer unnecessary operative deliveries and less unpredictable poor perinatal outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible women will be prospectively included in the cohort receiving conventional CTG monitoring. From the eligible women in the prospective cohort a random sample (90.9%) will be offered eCTG monitoring via a computer generated random collection. Participants will receive eCTG monitoring from the start of fetal monitoring during labour until 1.5 hour after delivery. A retrospective cohort of 2100 women who received conventional CTG monitoring between April 2019 and February 2023 will be added to the prospective cohort for statistical analysis.
| Arm | Type | Receives |
|---|---|---|
| eCTG monitoring | Active comparator | Device: eCTG monitoring with the NFMSeCTG monitoring with the Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands). The NFMS consists of a wireless and beltless electrode patch on the maternal abdomen. It monitors fetal heart rate by fetal electrocardiography, maternal heart rate by maternal electrocardiography and the electrical activity of the uterine muscle by electrohysterography. The advantage of the NFMS is that it is a safe method that can be used in all situations that are contraindicated for invasive monitoring. Furthermore, it can be used when the membranes are not ruptured and the patch does not have to be repetitively repositioned during labor. Because the NFMS is wireless, it gives women more freedom of movement during labor. |
| Conventional CTG monitoring | No intervention | –Philips Avalon FM 30 (Philips Healthcare, Eindhoven, the Netherlands). The fetal heart rate is measured non-invasively by doppler ultrasound or invasively by fetal scalp electrode. The uterine activity and maternal heart rate is measured by tocodynamometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimal age of 18 years old
- Pregnant women with a gestational age between 37+0 and 42+0 weeks and days
- Indication for fetal monitoring during labour
- Singleton fetus in cephalic position
- Oral and written informed consent is obtained
Key exclusion criteria (10 listed)
- Insufficient knowledge of Dutch or English language
- Women with a multiple pregnancy
- Fetal and/or maternal cardiac arrhythmias
- 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, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal)
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 |
|---|---|---|
| eCTG monitoring with the NFMSDevice: Nemo Fetal Monitoring System (Nemo Healthcare B.V., Veldhoven, the Netherlands) | Device | eCTG monitoring |
Primary outcome
The number of operative interventions during labor
Time frame: During delivery
cesarean section or instrumental vaginal delivery
35 secondary outcomes
Duration of the first stage of labor in minutes
Time frame: 0-10 cm dilation during labor
Duration of the second stage of labor in minutes
Time frame: Start pushing until childbirth
The timing and reason of operative interventions during labor
Time frame: During delivery
The number of participants with analgesia for pain reduction: epidural or/and remifentanil
Time frame: During delivery
Perineal laceration (grade 1, 2, 3a, 3b, 3c, 4)
Time frame: Directly after childbirth
The number of participants with a mediolateral episiotomy and reason for the episiotomy
Time frame: Directly after childbirth
Number (percentage) and result of fetal blood sampling during the primary and secondary stages of labour
Time frame: During delivery
Perinatal mortality
Time frame: During pregnancy up to seven completed days of life
Neonatal mortality
Time frame: After the seventh day but before the 28th day of life
The number of neonates with hypoxic ischemic encephalopathy
Time frame: childbirth - 28th day postpartum
The number of neonates with Neonatal Respiratory Distress Syndrome (RDS)
Time frame: childbirth - 28th day postpartum
The number of neonates with Meconium Aspiration Syndrome (MAS)
Time frame: childbirth - 28th day postpartum
The number of neonates with convulsions
Time frame: childbirth - 28th day postpartum
The number of neonates with Clinical early onset sepsis
Time frame: childbirth - 28th day postpartum
The number of neonates with Confirmed early onset sepsis
Time frame: childbirth - 72 hours after childbirth
The number of neonates with admission to Neonatal Intensive Care Unit
Time frame: childbirth - 28th day postpartum
Length of Admission to Neonatal Intensive Care Unit
Time frame: childbirth - 28th day postpartum
Reason for the admission to Neonatal Intensive Care Unit
Time frame: childbirth - 28th day postpartum
The number of neonates with the need for mechanical ventilation
Time frame: childbirth - 72 hours after childbirth
The number of neonates with a 5 minute Apgar score <7
Time frame: 5 minutes after childbirth
The number of neonates with a neonatal acidosis at birth
Time frame: Directly after childbirth
Maternal mortality
Time frame: During pregnancy and childbirth or within 42 days of termination of pregnancy
The number of mothers admitted to the Intensive Care Unit
Time frame: childbirth until six weeks postpartum
The number of mothers with a thromboembolic event
Time frame: childbirth until six weeks postpartum
The number of mothers with an uterine rupture
Time frame: childbirth until six weeks postpartum
The number of mothers with an obstetric haemorrhage
Time frame: childbirth until 24 hours after childbirth
The number of mothers with a postpartum anemia due to postpartum haemorrhage with requires red cell transfusion
Time frame: childbirth until six weeks postpartum
The number of mothers with a suspected or confirmed postpartum infection requiring antibiotics
Time frame: childbirth until six weeks postpartum
Patient satisfaction by questionnaires
Time frame: 2-6 hours after childbirth
Professional satisfaction by questionnaire
Time frame: 1 year after the start of the study
Costs as a business case model until six weeks postpartum
Time frame: Delivery until six weeks postpartum
For eCTG monitoring: amount of signal loss in percentage of total duration during labour
Time frame: During delivery
For eCTG monitoring: frequency of switch from Nemo Fetal Monitoring System to conventional CTG + reason, timing and success percentage of the switch
Time frame: During delivery
For eCTG monitoring: EHG pattern within the first 1.5 hours postpartum and the possible association with the amount of bloodloss, medication use and time to placental expulsion
Time frame: First 1.5 hours postpartum
For eCTG monitoring: EHG pattern before and after labour analgesia and the possible association of EHG pattern with labour analgesia
Time frame: During delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 40701589Berben PBQ, de Klerk ND, van der Ven M, Fransen AF, Niemarkt HJ, van den Heuvel ER, van der Hout-van der Jagt MB, Oei SG, van Laar JOEH. Non-invasive electrophysiological monitoring vs conventional monitoring during labour in a tertiary obstetric care centre in the Netherlands: study protocol of a cohort intervention random sampling study (NIEM-II study). BMJ Open. 2025 Jul 22;15(7):e102901. doi: 10.1136/bmjopen-2025-102901.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCTG monitoring with the NFMS in people with Fetal Monitoring and Non-invasive, 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 5 inclusion and 10 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 15 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of operative interventions during labor (time frame: During delivery). 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 NCT06135961, which also lists 1 linked publication.
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 15 Dec 2023.