Fetal Scalp pH During Labour: is it Worth Repeating

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT05900596
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 22

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abnormal Fetal Heart Rate	Diagnostic Test: Fetal blood sampling

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Fetal Scalp pH During Labour: is it Worth Repeating
• Actual Study Start Date: Feb 1, 2022
• Actual Primary Completion Date: Jul 31, 2022
• Actual Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Delivery [baseline]

   Vaginal delivery, operative delivery, cesarean section

Secondary Outcome Measures

1. Apgar score [baseline]

   value of Apgar score at five minutes of life

2. umbilical cord pH [baseline]

   value of umbilical cord pH

3. umbilical cord lactates [baseline]

   value of umbilical cord lactates

4. neonatal care intensive unit transfer [baseline]

   rate of neonatal care intensive unit transfer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional University Maternity of Nancy	Nancy	Meurthe-et-Moselle	France	54000

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TOURNIER Mathilde, Resident, Obstetrics and Gynecology, Principal Investigator, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05900596
• Other Study ID Numbers: 2023PI036
• First Posted: Jun 12, 2023
• Last Update Posted: Jun 15, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by TOURNIER Mathilde, Resident, Obstetrics and Gynecology, Principal Investigator, Central Hospital, Nancy, France: fetal scalp blood sampling; fetal blood sampling; cesarean section; non-reassuring fetal heart rate

Study Results

No Results Posted as of Jun 15, 2023