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New treatment option for Pregnancy Related
Official title Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
ClinicalTrials.gov ID: NCT06859177
What this study is testing
- What it's testing
- The objective of this single center, interventional cohort study is to evaluate the feasibility of remote electrophysiological cardiotocography (eCTG) monitoring in complicated pregnancies in a home@hospital setting. The primary objective is to assess: The success rate of the self-administered eCTG measurement The secondary objective is to asses: Maternal and perinatal outcomes Patients wellbeing and satisfaction.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Minimum age of 18 years old
- Pregnant patients with a gestational age between 32+0 and 36+6 weeks and days
- Singleton pregnancy
- Any indication for fetal monitoring at least twice per week (e.g.):
You likely can't join if
- \> 24 hours after admission.
- Oral and written informed consent is obtained. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from...
- An indication for intravenous medication
- Blood pressure \>160/110 A millimeter of mercury (mmHg)
- Absent-/or reversed flow umbilical artery Doppler
- Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) (Table 1)
See the full eligibility criteria
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Minimum age of 18 years old
- Pregnant patients with a gestational age between 32+0 and 36+6 weeks and days
- Singleton pregnancy
- Any indication for fetal monitoring at least twice per week (e.g.):
- Pre-eclampsia (PE)
- Fetal growth restriction (FGR)
- Preterm pre-labor rupture of membranes (PPROM)
- Absence of
- \> 24 hours after admission.
- Oral and written informed consent is obtained. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:
- An indication for intravenous medication
- Blood pressure \>160/110 A millimeter of mercury (mmHg)
- Absent-/or reversed flow umbilical artery Doppler
- Hemolysis Elevated Liver enzymes and Low Platelets (HELLP) (Table 1)
- Obstetric intervention expected \<48 hours, e.g. due to:
- Non reassuring cardiotocography (CTG)
- Active vaginal blood loss
- Signs of abruption placentae
- Meconium stained amniotic fluid
- Signs of chorioamnionitis
- Patients admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).
- Insufficient knowledge of Dutch or English language
- Insufficient comprehension of instruction Nemo Remote® or patient information
- Fetal and/or maternal cardiac arrhythmias
- Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper)
- Patients connected to an external or implanted electrical stimulator, such as Transcutaneous Electro Neuro Stimulation (TENS) and pacemaker (because of disturbance of the electrophysiological signal).
The study team makes the final eligibility decision.
Where it's taking place
- Veldhoven, North Brabant, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Veldhoven, North Brabant, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.