Fetal Scalp pH During Labour: is it Worth Repeating

June 12, 2023 updated by: TOURNIER Mathilde, Central Hospital, Nancy, France
In order to reduce the cesarean sections rate, an adjunctive test is recommended in case of non-reassuring fetal heart rate tracing. In France, the reference adjunctive test is fetal scalp blood sampling. However, there is no study about the repetition of fetal blood sampling. Our hypothesis is that the repetition of fetal blood sampling is useful when fetal heart rate stays non-reassuring and may lead to vaginal delivery without impair neonatal prognostic. Therefore, our objective was to compare the patients with three or more fetal blood sampling with the patients with one or two.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54000
        • Regional University Maternity of Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Regional University Maternity of Nancy

Description

Inclusion Criteria:

  • One fetal blood sampling during labour or more
  • Singleton pregnancy
  • Gestational age equal or above 37 weeks
  • No contra-indication of fetal blood sampling
  • No pregnancy complication

Exclusion Criteria:

  • Sampling failure
  • Incomplete file

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pH < 3
Patients one or two fetal blood sampling
Diagnostic test: Fetal blood sampling
Fetal scalp blood sampling and analysis
pH > 3
Patients with three or more fetal blood sampling
Diagnostic test: Fetal blood sampling
Fetal scalp blood sampling and analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery
Time Frame: baseline
Vaginal delivery, operative delivery, cesarean section
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apgar score
Time Frame: baseline
value of Apgar score at five minutes of life
baseline
umbilical cord pH
Time Frame: baseline
value of umbilical cord pH
baseline
umbilical cord lactates
Time Frame: baseline
value of umbilical cord lactates
baseline
neonatal care intensive unit transfer
Time Frame: baseline
rate of neonatal care intensive unit transfer
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023PI036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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