Clinical trial NCT02085772: Leukocytes - ObeSity - Spontaneous Labour
Official title: Is Impaired Activation and Migration of Circulating Leukocytes Associated With Overdue Birth in Obese Women?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-conceptional Obesity
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: To determine the initiation of spontaneous labour
timeFrame: Women will be followed until the release of motherhood after giving birth
Secondary outcomes:
measure: Occurrence of a vaginal delivery
timeFrame: Women will be followed until the release of motherhood after giving birth
measure: Occurrence of prolonged pregnancy
timeFrame: Women will be followed until the release of motherhood after giving birth
measure: Occurrence of a term exceeding
timeFrame: Women will be followed until the release of motherhood after giving birth
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References: