Leukocytes - ObeSity - Spontaneous Labour | NCT02085772

Studies
Leukocytes - ObeSity - Spontaneous Labour

NCT02085772

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Jun 11, 2024Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

Pre-conceptional Obesity

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2014Actual

Primary Completion Date

Oct 22, 2023Actual

Completion Date

Oct 22, 2023Actual

First Submitted Date

Mar 5, 2014

First Submission Date that Met QC Criteria

Mar 11, 2014

First Posted Date

Mar 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2024

Last Update Posted Date

Jun 11, 2024Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with pre-conceptional obesity	Experimental		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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood samples at 37-38 Weeks of amenorrhea	Other		Patients with pre-conceptional obesity
Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the initiation of spontaneous labour		Women will be followed until the release of motherhood after giving birth

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of a vaginal delivery		Women will be followed until the release of motherhood after giving birth
Occurrence of prolonged pregnancy		Women will be followed until the release of motherhood after giving birth

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided