ClinicalTrials.Veeva

Menu

Leukocytes - ObeSity - Spontaneous Labour (LOST)

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Pre-conceptional Obesity

Treatments

Other: Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy
Other: Blood samples at 37-38 Weeks of amenorrhea
Other: Blood samples at the time of delivery

Study type

Interventional

Funder types

Other

Identifiers

NCT02085772
WENDREMAIRE APJ 2013

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

88 participants in 1 patient group

Patients with pre-conceptional obesity
Experimental group
Treatment:
Other: Blood samples at the time of delivery
Other: Blood samples at 37-38 Weeks of amenorrhea
Other: Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy

Trial contacts and locations

1

Loading...

Central trial contact

Maeva WENDREMAIRE

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems