Abnormal Fetal Heart RateNCT05900596
Fetal Scalp pH During Labour: is it Worth Repeating
An observational study of Abnormal Fetal Heart Rate, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abnormal Fetal Heart Rate
- What is being tested?
- Fetal blood sampling
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 31 Jul 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Regional University Maternity of Nancy
Who may be able to join
- 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
Who cannot join
- Sampling failure
- Incomplete file
Trial locations and contacts
1 site in 1 country.
France1 site
Regional University Maternity of Nancy
Nancy, Meurthe-et-Moselle, 54000
About this study
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.
- Conditions
- Abnormal Fetal Heart Rate
- Being tested
- Fetal blood sampling
- Keywords
- fetal scalp blood sampling, fetal blood sampling, cesarean section, non-reassuring fetal heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal blood samplingDiagnostic test
Fetal scalp blood sampling and analysis
| Study group | Role | What they receive |
|---|---|---|
| pH < 3 | Patients one or two fetal blood sampling Receives: Diagnostic Test: Fetal blood sampling | |
| pH > 3 | Patients with three or more fetal blood sampling Receives: Diagnostic Test: Fetal blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery
Vaginal delivery, operative delivery, cesarean section
Measured: baseline
Secondary outcomes (4)
Apgar score
value of Apgar score at five minutes of life
Measured: baseline
umbilical cord pH
value of umbilical cord pH
Measured: baseline
umbilical cord lactates
value of umbilical cord lactates
Measured: baseline
neonatal care intensive unit transfer
rate of neonatal care intensive unit transfer
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Feb 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Fetal Heart RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOURNIER Mathilde, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900596
- Sponsor's protocol ID
- 2023PI036
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Scalp pH During Labour: is it Worth Repeating
- ClinicalTrials.gov ID
- NCT05900596
- Acronym / sponsor ID
- 2023PI036
- Conditions
- Abnormal Fetal Heart Rate
- Keywords
- fetal scalp blood sampling, fetal blood sampling, cesarean section, non-reassuring fetal heart rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pH < 3 | – | Diagnostic Test: Fetal blood samplingPatients one or two fetal blood sampling |
| pH > 3 | – | Diagnostic Test: Fetal blood samplingPatients with three or more fetal blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Regional University Maternity of Nancy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Sampling failure
- Incomplete file
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal blood samplingFetal scalp blood sampling and analysis | Diagnostic test | pH < 3, pH > 3 |
Primary outcome
Delivery
Time frame: baseline
Vaginal delivery, operative delivery, cesarean section
4 secondary outcomes
Apgar score
Time frame: baseline
umbilical cord pH
Time frame: baseline
umbilical cord lactates
Time frame: baseline
neonatal care intensive unit transfer
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Fetal Heart Rate, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.