NCT04632017 (COCA-PROM) is a clinical trial of Computerized cardiotocography in Cardiotocography, sponsored by University of Campania Luigi Vanvitelli.

Who is sponsoring NCT04632017?

NCT04632017 is sponsored by University of Campania Luigi Vanvitelli.

What drugs are being tested in NCT04632017?

Interventions in NCT04632017: Computerized cardiotocography.

What condition does NCT04632017 study?

NCT04632017 studies Cardiotocography, Premature Rupture of Membrane, Rupture of Membranes; Premature, Sepsis, Premature Birth.

Is NCT04632017 still recruiting?

NCT04632017 is currently status unknown. Last updated 17 November 2020.

Last reviewed 2020-11-17 · How we verify

NCT04632017: COCA-PROM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Computerized Cardiotocography Monitoring of Fetuses With pPROM

Status unknown Last updated 17 November 2020

What this trial tests

trial testing Computerized cardiotocography in Cardiotocography in 40 participants. Status unknown.

Timeline

15 June 2020

Primary endpoint
30 March 2021

30 July 2021

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	40
Start date	15 June 2020
Primary completion	30 March 2021
Estimated completion	30 July 2021
Sites	1 location across Italy

Drugs / interventions tested

Computerized cardiotocography

Conditions studied

Cardiotocography — all drugs for Cardiotocography →
Premature Rupture of Membrane — all drugs for Premature Rupture of Membrane →
Rupture of Membranes; Premature — all drugs for Rupture of Membranes; Premature →
Sepsis — all drugs for Sepsis →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 40, female only, with Cardiotocography or Premature Rupture of Membrane. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Preterm premature rupture of membranes (PPROM) is associated with neonatal complications leading to a high rate of cerebral palsy, sepsis, and death. Choosing the best time of delivery is crucial to improve fetal outcome. The balance is between a premature delivery exposing the infant to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. There are no objective and reproducible tools to help in this decision-making process. Techniques most frequently used for fetal surveillance are biased by high inter- and intra-observer variability. Computerized cardiotocography (cCTG) identifies several objective parameters related to fetal heart rate (FHR) to determine fetal well-being. cCTG has been successfully used in fetuses with intrauterine growth restriction, but it has never been used in prospective studies to assess its role in the management of fetuses with PPROM. The investigators designed a case control study to highlight cCTG differences in PPROM pregnancies versus physiological pregnancies, to establish the effectiveness in predicting adverse outcome, and to develop a score to predict neonatal outcome.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Cardiotocography

Currently open trials in the same condition.

NCT07078786 — Effect of Pre-delivery Dexamethasone in Comparison With Betamethasone on Fetal Heart Trace · Phase 4 · recruiting
NCT07124325 — Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care · NA · recruiting
NCT05904314 — Evaluation of the Effectiveness of Teaching Method With Simulation in Electronic Fetal Monitoring Management · NA · recruiting

Other University of Campania Luigi Vanvitelli trials

Trials by the same sponsor.

NCT07590349 — Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting · NA · not yet recruiting
NCT06718452 — Tinnitus and Treatment With umPEA-LUT · NA · not yet recruiting
NCT07124676 — Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to · not yet recruiting
NCT07425912 — Real-World Evaluation of TouchCare Nano in Pediatric Type 1 Diabetes · active not recruiting
NCT06991816 — The Brain&Senses Study · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04632017 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Campania Luigi Vanvitelli
Last refreshed: 17 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04632017.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing