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Autophagy/Apoptosis Balance During Pregnancy

Autophagy/Apoptosis Balance During Pregnancy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04443660
Acronym
GROSSAUTOP
Enrollment
97
Registered
2020-06-23
Start date
2020-12-30
Completion date
2025-04-07
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

Keywords

Autophagy, Apoptosis

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.

Interventions

OTHERBlood test

Blood samples taken to test levels of autophagy and apoptosis

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients followed at the CHU Nimes 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

Design outcomes

Primary

MeasureTime frameDescription
Potential autophagy induction activity in all groupsDay 0Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

Secondary

MeasureTime frameDescription
Potential apoptosis induction activity in all groupsDay 0% cells positive for Annexin V
Inter- and intra-individual apoptosis/autophagy ratio in all groupsDay 0
Autophagy kinetics between groupsDay 0measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
Apoptosis kinetics between groupsDay 0measured by % cells positive for Annexin V
Placental Growth Factor in each groupDay 0pg/ml measured by ELISA
Soluble fms-like tyrosine kinase-1Day 0pg/ml measured by ELISA
Constitutive thrombophiliaDay 0presence/absence of the prothrombin gene or factor V Leiden mutation, protein S, C or antithrombin deficiency
Acquired thrombophiliaDay 0Presence/absence of anti-phospholipid antibodies (lupus anticoagulant and/or anti beta2-GP1 and/or anti-cardiolipid).
Type of autophagy inhibition per patient in all groupsDay 0Early/late; measured by microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio
Renal functionDay 0creatinemia, proteinuria / creatinuria ratio
Fibrin levelsDay 0D dimers and fibrin monomers
InflammationDay 0C-reactive protein level
Activated partial thromboplastin timeDay 0seconds
Prothrombin timeDay 0seconds
Fibrinogen levelDay 0g/L
Thrombin generation timeMonth 1seconds
fetal haemoglobinMonth 1g/L
Whole blood countDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026