Autophagy/Apoptosis Balance During Pregnancy

NCT04443660 | Completed

• 1 other identifier: NIMAO/2019-01/SB-01
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Autophagy; Apoptosis

Outcome Measures

Primary Outcomes (7)

• Potential autophagy induction activity in all groups

  Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  Day 0

• Potential autophagy induction activity in all groups

  Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  Month 1

• Potential autophagy induction activity in all groups

  Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  Month 2

• Potential autophagy induction activity in all groups

  Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  Month 3

• Potential autophagy induction activity in all groups

  Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  Month 4

• Potential autophagy induction activity in all groups

  Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  Month 5

• Potential autophagy induction activity in all groups

  Microtubule-associated protein 1A/1B-light chain 3 fluorescence ratio

  Delivery plus or minus 2 weeks (Month 6)

Secondary Outcomes (119)

• Type of autophagy inhibition per patient in all groups

  Day 0

• Type of autophagy inhibition per patient in all groups

  Month 1

• Type of autophagy inhibition per patient in all groups

  Month 2

• Type of autophagy inhibition per patient in all groups

  Month 3

• Type of autophagy inhibition per patient in all groups

  Month 4

Study Arms (4)

Group A

without medical history or risk factors, with a normal pregnancy

Other: Blood test

Group B

without medical history or risk factors, developing a pregnancy complication

Other: Blood test

Group C

with risk of complication, having a normal pregnancy

Other: Blood test

Group D

with a risk of complication, developing a pregnancy complication

Other: Blood test

Interventions

Blood test OTHER

Blood samples taken to test levels of autophagy and apoptosis

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women followed at the Nimes 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

Related Publications (1)

• Fortier M, Portes M, Demattei C, Nouvellon E, Mercier E, Bourguignon C, Chea M, Gris JC, Letouzey V, Bouvier S. Thrombin generation reference values using the ST Genesia and STG-Thromboscreen assay in pregnant women. Thromb Res. 2026 Jan;257:109558. doi: 10.1016/j.thromres.2025.109558. Epub 2025 Nov 29. No abstract available.

  PMID: 41371090 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and mononuclear blood cells

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Sylvie Bouvier

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 23, 2020
• Study Start: December 30, 2020
• Primary Completion: September 30, 2024
• Study Completion: April 7, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)