Pre-conceptional ObesityLOSTNCT02085772
Leukocytes - ObeSity - Spontaneous Labour
A study testing Blood samples at 37-38 Weeks of amenorrhea, Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy and Blood samples at the time of delivery in people with Pre-conceptional Obesity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-conceptional Obesity
- What is being tested?
- Blood samples at 37-38 Weeks of amenorrhea, Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy and Blood samples at the time of delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2014to 22 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
- Conditions
- Pre-conceptional Obesity
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples at 37-38 Weeks of amenorrheaOther
Blood samples at 41 Weeks of amenorrhea if prolonged pregnancyOther
Blood samples at the time of deliveryOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with pre-conceptional obesity | Experimental | Not described Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
To determine the initiation of spontaneous labour
Measured: Women will be followed until the release of motherhood after giving birth
Secondary outcomes (3)
Occurrence of a vaginal delivery
Measured: Women will be followed until the release of motherhood after giving birth
Occurrence of prolonged pregnancy
Measured: Women will be followed until the release of motherhood after giving birth
Occurrence of a term exceeding
Measured: Women will be followed until the release of motherhood after giving birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study start5 Feb 2014
- Primary completion22 Oct 2023
- Study completion22 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-conceptional ObesityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085772
- Sponsor's protocol ID
- WENDREMAIRE APJ 2013
- Acronym
- LOST
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2014
- Last updated
- 11 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Impaired Activation and Migration of Circulating Leukocytes Associated With Overdue Birth in Obese Women?
- ClinicalTrials.gov ID
- NCT02085772
- Acronym / sponsor ID
- LOST / WENDREMAIRE APJ 2013
- Conditions
- Pre-conceptional Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- 22 Oct 2023 (actual)
- Study completion
- 22 Oct 2023 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples at 37-38 Weeks of amenorrhea | Other | Patients with pre-conceptional obesity |
| Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy | Other | Patients with pre-conceptional obesity |
| Blood samples at the time of delivery | Other | Patients with pre-conceptional obesity |
Primary outcome
To determine the initiation of spontaneous labour
Time frame: Women will be followed until the release of motherhood after giving birth
3 secondary outcomes
Occurrence of a vaginal delivery
Time frame: Women will be followed until the release of motherhood after giving birth
Occurrence of prolonged pregnancy
Time frame: Women will be followed until the release of motherhood after giving birth
Occurrence of a term exceeding
Time frame: Women will be followed until the release of motherhood after giving birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples at 37-38 Weeks of amenorrhea, Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy and Blood samples at the time of delivery in people with Pre-conceptional Obesity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the initiation of spontaneous labour (time frame: Women will be followed until the release of motherhood after giving birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 3 Nov 2026.