Clinical trial NCT04443660: Autophagy/Apoptosis Balance During Pregnancy
Official title: Autophagy/Apoptosis Balance During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Keywords: Autophagy
Apoptosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women followed at the Nîmes University Hospital for their pregnancy. Patients will be recruited among those consulting hospital gynecologists from the 3rd month of pregnancy but also through the circuit of specific gynecology-obstetrics consultations receiving in particular women with a history and / or risk factors for pathological pregnancy

Brief summary: The object of this study is to assess the intra- and inter-individual variability of apoptosis and autophagy activities in women during pregnancy: 1 / in women with a normal pregnancy and 2 / in pregnant women particularly at risk of complications.

The study investigators hypothesize that there would be an intra-trophoblastic dialogue between the mechanisms of autophagy and apoptosis, the promotion of one partially inhibiting the other. The increase in trophoblastic autophagy during pregnancy could thus constitute an anti-apoptosis defense phenomenon, the exhaustion of which would lead to cellular apoptosis and to pathogenic consequences when it devastates the syncytiotrophoblast.


Eligibility criteria: Inclusion Criteria:

* Patients followed at the CHU Nîmes prior to 33 weeks gestation who give birth at the hospital
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in a category 1 interventional study associated with a medication, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Multiple pregnancy

Primary outcomes:
measure: Potential autophagy induction activity in all groups
timeFrame: Day 0
measure: Potential autophagy induction activity in all groups
timeFrame: Month 1
measure: Potential autophagy induction activity in all groups
timeFrame: Month 2
measure: Potential autophagy induction activity in all groups
timeFrame: Month 3
measure: Potential autophagy induction activity in all groups
timeFrame: Month 4
measure: Potential autophagy induction activity in all groups
timeFrame: Month 5
measure: Potential autophagy induction activity in all groups
timeFrame: Delivery plus or minus 2 weeks (Month 6)
Secondary outcomes:
measure: Type of autophagy inhibition per patient in all groups
timeFrame: Day 0
measure: Type of autophagy inhibition per patient in all groups
timeFrame: Month 1
measure: Type of autophagy inhibition per patient in all groups
timeFrame: Month 2
measure: Type of autophagy inhibition per patient in all groups
timeFrame: Month 3
measure: Type of autophagy inhibition per patient in all groups
timeFrame: Month 4
measure: Type of autophagy inhibition per patient in all groups
timeFrame: Month 5
measure: Type of autophagy inhibition per patient in all groups
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Potential apoptosis induction activity in all groups
timeFrame: Day 0
measure: Potential apoptosis induction activity in all groups
timeFrame: Month 1
measure: Potential apoptosis induction activity in all groups
timeFrame: Month 2
measure: Potential apoptosis induction activity in all groups
timeFrame: Month 3
measure: Potential apoptosis induction activity in all groups
timeFrame: Month 4
measure: Potential apoptosis induction activity in all groups
timeFrame: Month 5
measure: Potential apoptosis induction activity in all groups
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
timeFrame: Day 0
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
timeFrame: Month 1
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
timeFrame: Month 2
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
timeFrame: Month 3
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
timeFrame: Month 4
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
timeFrame: Month 5
measure: Inter- and intra-individual apoptosis/autophagy ratio in all groups
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Autophagy kinetics between groups
timeFrame: Day 0
measure: Autophagy kinetics between groups
timeFrame: Month 1
measure: Autophagy kinetics between groups
timeFrame: Month 2
measure: Autophagy kinetics between groups
timeFrame: Month 3
measure: Autophagy kinetics between groups
timeFrame: Month 4
measure: Autophagy kinetics between groups
timeFrame: Month 5
measure: Autophagy kinetics between groups
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Apoptosis kinetics between groups
timeFrame: Day 0
measure: Apoptosis kinetics between groups
timeFrame: Month 1
measure: Apoptosis kinetics between groups
timeFrame: Month 2
measure: Apoptosis kinetics between groups
timeFrame: Month 3
measure: Apoptosis kinetics between groups
timeFrame: Month 4
measure: Apoptosis kinetics between groups
timeFrame: Month 5
measure: Apoptosis kinetics between groups
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Placental Growth Factor in each group
timeFrame: Day 0
measure: Placental Growth Factor in each group
timeFrame: Month 1
measure: Placental Growth Factor in each group
timeFrame: Month 2
measure: Placental Growth Factor in each group
timeFrame: Month 3
measure: Placental Growth Factor in each group
timeFrame: Month 4
measure: Placental Growth Factor in each group
timeFrame: Month 5
measure: Placental Growth Factor in each group
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Soluble fms-like tyrosine kinase-1
timeFrame: Day 0
measure: Soluble fms-like tyrosine kinase-1
timeFrame: Month 1
measure: Soluble fms-like tyrosine kinase-1
timeFrame: Month 2
measure: Soluble fms-like tyrosine kinase-1
timeFrame: Month 3
measure: Soluble fms-like tyrosine kinase-1
timeFrame: Month 4
measure: Soluble fms-like tyrosine kinase-1
timeFrame: Month 5
measure: Soluble fms-like tyrosine kinase-1
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Constitutive thrombophilia
timeFrame: Day 0
measure: Acquired thrombophilia
timeFrame: Day 0
measure: Acquired thrombophilia
timeFrame: Month 1
measure: Acquired thrombophilia
timeFrame: Month 2
measure: Acquired thrombophilia
timeFrame: Month 3
measure: Acquired thrombophilia
timeFrame: Month 4
measure: Acquired thrombophilia
timeFrame: Month 5
measure: Acquired thrombophilia
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Whole blood count
timeFrame: Day 0
measure: Whole blood count
timeFrame: Month 1
measure: Whole blood count
timeFrame: Month 2
measure: Whole blood count
timeFrame: Month 3
measure: Whole blood count
timeFrame: Month 4
measure: Whole blood count
timeFrame: Month 5
measure: Whole blood count
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Renal function
timeFrame: Day 0
measure: Renal function
timeFrame: Month 1
measure: Renal function
timeFrame: Month 2
measure: Renal function
timeFrame: Month 3
measure: Renal function
timeFrame: Month 4
measure: Renal function
timeFrame: Month 5
measure: Renal function
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Fibrin levels
timeFrame: Day 0
measure: Fibrin levels
timeFrame: Month 1
measure: Fibrin levels
timeFrame: Month 2
measure: Fibrin levels
timeFrame: Month 3
measure: Fibrin levels
timeFrame: Month 4
measure: Fibrin levels
timeFrame: Month 5
measure: Fibrin levels
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Inflammation
timeFrame: Day 0
measure: Inflammation
timeFrame: Month 1
measure: Inflammation
timeFrame: Month 2
measure: Inflammation
timeFrame: Month 3
measure: Inflammation
timeFrame: Month 4
measure: Inflammation
timeFrame: Month 5
measure: Inflammation
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Activated partial thromboplastin time
timeFrame: Day 0
measure: Activated partial thromboplastin time
timeFrame: Month 1
measure: Activated partial thromboplastin time
timeFrame: Month 2
measure: Activated partial thromboplastin time
timeFrame: Month 3
measure: Activated partial thromboplastin time
timeFrame: Month 4
measure: Activated partial thromboplastin time
timeFrame: Month 5
measure: Activated partial thromboplastin time
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Prothrombin time
timeFrame: Day 0
measure: Prothrombin time
timeFrame: Month 1
measure: Prothrombin time
timeFrame: Month 2
measure: Prothrombin time
timeFrame: Month 3
measure: Prothrombin time
timeFrame: Month 4
measure: Prothrombin time
timeFrame: Month 5
measure: Prothrombin time
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Fibrinogen level
timeFrame: Day 0
measure: Fibrinogen level
timeFrame: Month 1
measure: Fibrinogen level
timeFrame: Month 2
measure: Fibrinogen level
timeFrame: Month 3
measure: Fibrinogen level
timeFrame: Month 4
measure: Fibrinogen level
timeFrame: Month 5
measure: Fibrinogen level
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Thrombin generation time
timeFrame: Month 1
measure: Thrombin generation time
timeFrame: Month 2
measure: Thrombin generation time
timeFrame: Month 3
measure: Thrombin generation time
timeFrame: Month 4
measure: Thrombin generation time
timeFrame: Month 5
measure: Thrombin generation time
timeFrame: Delivery plus or minus 2 weeks (Month 6)
measure: Thrombin generation time
timeFrame: Day 0
measure: fetal haemoglobin
timeFrame: Month 1
measure: fetal haemoglobin
timeFrame: Month 2
measure: fetal haemoglobin
timeFrame: Month 3
measure: fetal haemoglobin
timeFrame: Month 4
measure: fetal haemoglobin
timeFrame: Month 5
measure: fetal haemoglobin
timeFrame: Delivery plus or minus 2 weeks (Month 6)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Sylvie Bouvier
role: PRINCIPAL_INVESTIGATOR
References: