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Completed

NCT Number: NCT02085772

Leukocytes - ObeSity - Spontaneous Labour

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.

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Key information

Conditions

Pre-conceptional Obesity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de DIJON

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

  1. To determine the initiation of spontaneous labour

    Time frame: Women will be followed until the release of motherhood after giving birth

Secondary outcomes

  1. Occurrence of a vaginal delivery

    Time frame: Women will be followed until the release of motherhood after giving birth

  2. Occurrence of prolonged pregnancy

    Time frame: Women will be followed until the release of motherhood after giving birth

  3. Occurrence of a term exceeding

    Time frame: Women will be followed until the release of motherhood after giving birth

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Is Impaired Activation and Migration of Circulating Leukocytes Associated With Overdue Birth in Obese Women?

Acronym: LOST

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2014
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.