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Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Només els usuaris registrats poden traduir articles
Inicieu sessió / registreu-vos
L'enllaç es desa al porta-retalls
EstatCompletat
Patrocinadors
Federico II University

Paraules clau

Resum

Electronic fetal hear rate monitoring (EFM), or cardiotocography (CTG), records changes in fetal heart rate and their temporal relationship to uterine contraction. It has been developed with the aim of detecting fetal hypoxia during labor and hence to prevent metabolic acidosis. Despite being the standard for intrapartum management, this technique, significantly increase the operative delivery rate, and is associated only with less seizures as neonatal benefit. Another concern is also the variability in the interpretation.
Several techniques have been studied in order to decrease the high false positive rate. Fetal ST waveform analysis (STAN) has been studied combined with CTG. A recent meta-analysis of randomized trials, however, showed that STAN during labor did not improve perinatal outcomes or decrease operative delivery rates, except for a 9% decrease in operative vaginal delivery.Comparisons of visual and computerized interpretation of EFM have also been reported. However, whether or fetal monitoring with computer analysis improve perinatal outcomes is still subject of debate.
Thus, we aim to evaluate whether intrapartum fetal monitoring with computer analysis increase the incidence of obstetric intervention when compared with visual analysis through a single-center randomized controlled trial.

Dates

Darrera verificació: 06/30/2020
Primer enviat: 02/28/2019
Inscripció estimada enviada: 02/28/2019
Publicat per primera vegada: 03/04/2019
Última actualització enviada: 07/07/2020
Publicació de l'última actualització: 07/08/2020
Data d'inici de l'estudi real: 02/28/2019
Data estimada de finalització primària: 12/14/2019
Data estimada de finalització de l’estudi: 03/22/2020

Condició o malaltia

Cesarean Section

Intervenció / tractament

Diagnostic Test: computerized cardiotocography

Fase

-

Grups de braços

BraçIntervenció / tractament
Experimental: computerized cardiotocography
computerized cardiotocography
Active Comparator: standard cardiotocography
standard cardiotocography non stresstest

Criteris d'elegibilitat

Edats elegibles per estudiar 18 Years Per a 18 Years
Sexes elegibles per estudiarFemale
Accepta voluntaris saludables
Criteris

Inclusion Criteria:

- Women with singleton gestation

- 18 years to 50 years

- High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia

Exclusion Criteria:

- IUGR

Resultat

Mesures de resultats primaris

1. cesarean section [at the time of delivery]

incidence of cesarean section

Mesures de resultats secundaris

1. gestational age at delivery [at the time of delivery]

week of delivery

2. admission to neonatal intensive care unit [at the time of delivery]

admission to neonatal intensive care unit

3. birth weight [at the time of delivery]

neonatal birth weight at delivery

4. APGAR score at delivery [at the time of delivery]

APGAR score at delivery

5. neonatal death [28 days of live of the neonate]

death of a live neonates within 28 days of life

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