Monitoring and diagnosing fetal cardiac (ar)rhythmias per CTG-registration and fetal ECG by the Monica AN24tm.

Monitoring and diagnosing fetal cardiac (ar)rhythmias per CTG-registration and fetal ECG by the Monica AN24tm. - Fetal monitoring by the Monica AN24*.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34791

Enrollment

200

Registered

2010-04-12

Start date

2010-05-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart arrhythmias

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy pregnant women, above the age of 18, singleton pregnancy, voluntarily, minimal gestational age of 19 weeks, under care of the department of obstetrics of the LUMC.

Exclusion criteria

Exclusion criteria: Multiple pregnancies, underage, incapable of giving informed consent, no informed consent given

Design outcomes

Primary

Measure	Time frame
Totally, there will be made three times a CTG-registration by the Monica An24* and two times a conventional CTG registration per participant. Percentages of successful registration will be noted and are classified in groups (very good, good, temperate and bad). This will be done in the CTG-registrations of the Monica AN24* and in the current CTG-registrations and expressed per time interval; they will be compared with the chi-square test. The CTG-derivations (in percentages) from the Monica AN24* of the participants, divided by Body Mass Index (BMI= 30) are compared with the chi-square test. Using special software the fetal ECGs will be derived from CTG-registrations from the Monica AN24. Per time-interval the obtained fECGs will be judged and divided by differences in quality and usefulness. The fECGs are judged on P-wave, PR-interval, QRS-complex, T-wave and QT-interval. The fECG will be divided into quality categories, dependent on identifiable elements of the ECG: good (3 elements recognizable), moderate (QRS-complex and P-wave or T-wave recognizable), poor (only QRS-complex recognizable).The fECG will be examined by two independent and blinded pediatric cardiologists, without knowledge of the ultrasound results. The pediatric cardiologists will judge the fECGs on quality and measure PR-, ST- and QT-interval and QRS-complex. The quality data of the fECGs per time interval will be compared by chi-square test. Atrioventricular conduction times obtained by ultrasound tests will be compared with fECGs in time interval week 20-24 and it will be exposed in a Bland-Altmanfigure.	—

Measure

Time frame

Totally, there will be made three times a CTG-registration by the Monica An24* and two times a conventional CTG registration per participant. Percentages of successful registration will be noted and are classified in groups (very good, good, temperate and bad). This will be done in the CTG-registrations of the Monica AN24* and in the current CTG-registrations and expressed per time interval; they will be compared with the chi-square test. The CTG-derivations (in percentages) from the Monica AN24* of the participants, divided by Body Mass Index (BMI= 30) are compared with the chi-square test. Using special software the fetal ECGs will be derived from CTG-registrations from the Monica AN24*. Per time-interval the obtained fECGs will be judged and divided by differences in quality and usefulness. The fECGs are judged on P-wave, PR-interval, QRS-complex, T-wave and QT-interval. The fECG will be divided into quality categories, dependent on identifiable elements of the ECG: good (3 elements recognizable), moderate (QRS-complex and P-wave or T-wave recognizable), poor (only QRS-complex recognizable).The fECG will be examined by two independent and blinded pediatric cardiologists, without knowledge of the ultrasound results. The pediatric cardiologists will judge the fECGs on quality and measure PR-, ST- and QT-interval and QRS-complex. The quality data of the fECG*s per time interval will be compared by chi-square test. Atrioventricular conduction times obtained by ultrasound tests will be compared with fECGs in time interval week 20-24 and it will be exposed in a Bland-Altmanfigure.

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results