Fetal Scalp pH During Labour: is it Worth Repeating

NCT ID: NCT05900596

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Abnormal Fetal Heart Rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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pH < 3

Patients one or two fetal blood sampling

Fetal blood sampling

Intervention Type DIAGNOSTIC_TEST

Fetal scalp blood sampling and analysis

pH > 3

Patients with three or more fetal blood sampling

Fetal blood sampling

Intervention Type DIAGNOSTIC_TEST

Fetal scalp blood sampling and analysis

Interventions

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Fetal blood sampling

Fetal scalp blood sampling and analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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TOURNIER Mathilde

Resident, Obstetrics and Gynecology, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Regional University Maternity of Nancy

Nancy, Meurthe-et-Moselle, France

Site Status

Countries

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France

Other Identifiers

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2023PI036

Identifier Type: -

Identifier Source: org_study_id

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