Fetal Scalp pH During Labour: is it Worth Repeating | NCT05900596

Studies
Fetal Scalp pH During Labour: is it Worth Repeating

NCT05900596

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Jun 15, 2023Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Abnormal Fetal Heart Rate

Interventions

Fetal blood sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Jul 31, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

May 26, 2023

First Submission Date that Met QC Criteria

Jun 9, 2023

First Posted Date

Jun 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2023

Last Update Posted Date

Jun 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

TOURNIER Mathilde, Resident, Obstetrics and Gynecology, Principal Investigator, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pH < 3		Patients one or two fetal blood sampling	Diagnostic Test: Fetal blood sampling
pH > 3		Patients with three or more fetal blood sampling	Diagnostic Test: Fetal blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fetal blood sampling	Diagnostic Test	Fetal scalp blood sampling and analysis	pH < 3 pH > 3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Apgar score	value of Apgar score at five minutes of life	baseline
umbilical cord pH	value of umbilical cord pH	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Regional University Maternity of Nancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regional University Maternity of Nancy		Nancy	Meurthe-et-Moselle	54000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided