Leukocytes - ObeSity - Spontaneous Labour (LOST)

June 10, 2024 updated by: Centre Hospitalier Universitaire Dijon

Is Impaired Activation and Migration of Circulating Leukocytes Associated With Overdue Birth in Obese Women?

This is a single-centre observational, prospective study carried out at the maternity unit of Dijon CHU. It will include pregnant women with a pre-conception BMI ≥ 30 kg/m² and will evaluate in these patients, the activation and migration capacities of circulating leukocytes and their association with the onset of spontaneous labour.

Patients who meet the inclusion criteria will be informed about the study during their consultation at the 7th or 8th month, and their gynecologist will invite them to take part. If the answer is positive, the patients will be seen again at a specific consultation for the study between the 37th and 38the Weeks of amenorrhea at the maternity unit of Dijon CHU. During this consultation, the gynecologist will conduct a medical examination, while the Plurithematic clinical investigation center nurse will take a blood sample (3 x 6ml tubes and 1 x 7ml tube).

If labour has not started by 41 Weeks of amenorrhea, the patients will be seen at another consultation (consultation programmed in the usual follow-up of pregnancy) and a second blood sample (1 x 6ml tube and 1 x 7ml) will be taken.

The patients will be followed until childbirth and will be split into two groups according to whether or not they gave birth after the onset of spontaneous labour.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de Dijon

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient has given its written consent
  • Please affiliated to a social security scheme
  • Body Mass Index Preconception ≥ 30 kg / m²
  • Age> 18 years
  • Unique Pregnancy
  • Having a plot of Normal Fetal heart rate

Exclusion Criteria:

  • Pathology changing the mode of delivery or induction of labor (pre-eclampsia, chronic hypertension or gestational, diabetes under unbalanced diet, ...)
  • Scheduled Caesarean
  • Infectious Disease suspected or proven, including HIV infection, hepatitis C, hepatitis B
  • Pathology inflammatory or autoimmune
  • Anti-inflammatory or immunosuppressive therapy
  • Patient under guardianship

  • Patient in safeguarding justice

    • SECONDARY EXCLUSION CRITERIA:

  • Caesarean section before labor
  • Delivery before 37 Weeks of amenorrhea
  • Anti-inflammatory or immunosuppressive therapy during study participation
  • Fetal Heart Rate abnormal during study participation
  • Premature rupture of fetal membranes without formal labor spontaneously within 48 hours
  • Induction of labor or cervical ripening before 41SA

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with pre-conceptional obesity
Other: Blood samples at 37-38 Weeks of amenorrhea
Other: Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy
Other: Blood samples at the time of delivery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To determine the initiation of spontaneous labour
Time Frame: Women will be followed until the release of motherhood after giving birth
Women will be followed until the release of motherhood after giving birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Occurrence of a vaginal delivery
Time Frame: Women will be followed until the release of motherhood after giving birth
Women will be followed until the release of motherhood after giving birth
Occurrence of prolonged pregnancy
Time Frame: Women will be followed until the release of motherhood after giving birth
Women will be followed until the release of motherhood after giving birth
Occurrence of a term exceeding
Time Frame: Women will be followed until the release of motherhood after giving birth
Women will be followed until the release of motherhood after giving birth

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Dijon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WENDREMAIRE APJ 2013

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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