Leukocytes - ObeSity - Spontaneous Labour

NCT ID: NCT02085772

Last Updated: 2024-06-11

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

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-05

Study Completion Date

2023-10-22

Brief Summary

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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.

Detailed Description

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Conditions

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Pre-conceptional Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Study Groups

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Patients with pre-conceptional obesity

Group Type EXPERIMENTAL

Blood samples at 37-38 Weeks of amenorrhea

Intervention Type OTHER

Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy

Intervention Type OTHER

Blood samples at the time of delivery

Intervention Type OTHER

Interventions

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Blood samples at 37-38 Weeks of amenorrhea

Intervention Type OTHER

Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy

Intervention Type OTHER

Blood samples at the time of delivery

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de DIJON

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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WENDREMAIRE APJ 2013

Identifier Type: -

Identifier Source: org_study_id

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