Leukocytes - ObeSity - Spontaneous Labour (LOST)

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: Completed
• Conditions: Pre-conceptional Obesity
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu de Dijon

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	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
Occurrence of a term exceeding	Women will be followed until the release of motherhood after giving birth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2014
• Primary Completion (Actual): October 22, 2023
• Study Completion (Actual): October 22, 2023

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimated): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: WENDREMAIRE APJ 2013