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Clinical Trials/NL-OMON25988
NL-OMON25988
Not yet recruiting
Not Applicable

on-invasive fetal electrocardiography and speckle tracking echocardiography in the second trimester, 16 until 28 weeks gestational age: a prospective cohort study.

Board of Management Máxima Medical Center0 sites594 target enrollmentTBD
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ConditionsHDP, FGR, (Threatened) preterm birth.

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HDP, FGR, (Threatened) preterm birth.
Sponsor
Board of Management Máxima Medical Center
Enrollment
594
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Board of Management Máxima Medical Center

Eligibility Criteria

Inclusion Criteria

  • •Pregnant women with a singleton pregnancy;
  • •\- Uncomplicated pregnancy at the time of inclusion;
  • •\- Gestational age \<16\+0 weeks;
  • •\- Oral and written consent is obtained;
  • •\- Maternal age \= 18 years.

Exclusion Criteria

  • •\- Multiple pregnancies;
  • •\- Pre\-existing maternal disease that might influence fetal development (e.g. diabetes mellitus, pre\-existent hypertensive disease or auto\-immune disease); \- Abnormalities found at the structural ultrasound examination (SEO) that might possibly influence fetal cardiac function (e.g. fetal cardiac arrhythmias or congenital abnormalities);
  • •\- Contra\-indications to abdominal patch placement (e.g. 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);
  • •\- Insufficient ability in understanding Dutch or English language;
  • •\- Patient under the age of 18 years.

Outcomes

Primary Outcomes

Not specified

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