Leukocytes - ObeSity - Spontaneous Labour (LOST)
Primary Purpose
Pre-conceptional Obesity
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples at 37-38 Weeks of amenorrhea
Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy
Blood samples at the time of delivery
Sponsored by
About this trial
This is an interventional other trial for Pre-conceptional Obesity
Eligibility Criteria
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
Sites / Locations
- CHU de DIJONRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with pre-conceptional obesity
Arm Description
Outcomes
Primary Outcome Measures
To determine the initiation of spontaneous labour
Secondary Outcome Measures
Occurrence of a vaginal delivery
Occurrence of prolonged pregnancy
Occurrence of a term exceeding
Full Information
NCT ID
NCT02085772
First Posted
March 5, 2014
Last Updated
February 10, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02085772
Brief Title
Leukocytes - ObeSity - Spontaneous Labour
Acronym
LOST
Official Title
Is Impaired Activation and Migration of Circulating Leukocytes Associated With Overdue Birth in Obese Women?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2014 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-conceptional Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with pre-conceptional obesity
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood samples at 37-38 Weeks of amenorrhea
Intervention Type
Other
Intervention Name(s)
Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy
Intervention Type
Other
Intervention Name(s)
Blood samples at the time of delivery
Primary Outcome Measure Information:
Title
To determine the initiation of spontaneous labour
Time Frame
Women will be followed until the release of motherhood after giving birth
Secondary Outcome Measure Information:
Title
Occurrence of a vaginal delivery
Time Frame
Women will be followed until the release of motherhood after giving birth
Title
Occurrence of prolonged pregnancy
Time Frame
Women will be followed until the release of motherhood after giving birth
Title
Occurrence of a term exceeding
Time Frame
Women will be followed until the release of motherhood after giving birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maeva WENDREMAIRE
Phone
3 80 29 52 05
Ext
+33
Email
maeva.wendremaire@chu-dijon.fr
Facility Information:
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maeva WENDREMAIRE
Phone
3 80 29 52 05
Ext
+33
Email
maeva.wendremaire@chu-dijon.fr
12. IPD Sharing Statement
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Leukocytes - ObeSity - Spontaneous Labour
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