NCT06720363

Brief Summary

The goal of this observational study is to build a predictive model of fetal acidosis based on variables from the cardiotocographic tracing recorded during labor in participants undergoing spontaneous or induced delivery with single pregnancy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Jun 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jun 2024Aug 2028

Study Start

First participant enrolled

June 7, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

December 6, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

December 3, 2024

Last Update Submit

December 3, 2024

Conditions

Pregnancies At Increased Risk of Preterm Birth

Keywords

Fetal acidosispHcardiotocographyCTG

Outcome Measures

Primary Outcomes (1)

  • Fetal acidosis

    pH value ≤ 7.10

    During delivery

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

5000 participants will be enrolled. Participants in spontaneous or induced labor at the Delivery Room of the Operative Unit of Obstetrics and Prenatal Age Medicine, IRCCS AOUBO, Policlinico di Sant\'Orsola.

You may qualify if:

  • Maternal age between 18 and 45 years;
  • Single pregnancy
  • Participants undergoing continuous monitoring of labor labor
  • Obtaining informed consent for study participation and processing of personal data

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

  • Antonio Farina, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Farina, MD

CONTACT

0512143110antonio.farina@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

June 7, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

December 6, 2024

Record last verified: 2024-10

Locations

IT(1)