Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

• Sponsor: Federico II University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03862976
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Diagnostic Test: computerized cardiotocography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies
• Actual Study Start Date: Mar 25, 2019
• Actual Primary Completion Date: Dec 15, 2019
• Actual Study Completion Date: Mar 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: computerized cardiotocography computerized cardiotocography	Diagnostic Test: computerized cardiotocography; computerized cardiotocography (C-CTG)
Active Comparator: standard cardiotocography standard cardiotocography non stresstest	Diagnostic Test: computerized cardiotocography; computerized cardiotocography (C-CTG)

Outcome Measures

Primary Outcome Measures

1. cesarean section [at the time of delivery]

   incidence of cesarean section

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women with singleton gestation

• 18 years to 50 years

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

Exclusion Criteria:

• IUGR

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gabriele Saccone	Napoli		Italy	80129

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gabriele Saccone, doctor, Federico II University
• ClinicalTrials.gov Identifier: NCT03862976
• Other Study ID Numbers: 371/18
• First Posted: Mar 5, 2019
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 8, 2020