NCT03981653

Brief Summary

In vivo and ex vivo study of trophoblastic angiogenic trophoblastic function in placentas from normal pregnancies, at term

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2019Mar 2029

Study Start

First participant enrolled

March 20, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

10 years

First QC Date

June 7, 2019

Last Update Submit

December 20, 2022

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Level of placental angiogenic factors

    Variation in the gene and protein expression of placental angiogenic factors on healthy placentas

    day 0

Secondary Outcomes (2)

  • Level of sFlt-1 (Soluble FMS like tyrosin-kinase-1)

    day 1

  • Level of PlGF (Placental Growth Factor)

    day 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with a progressive, full-term pregnancy

You may qualify if:

  • Pregnancies with scheduled cesarean delivery \>37 weeks of amenorrhea:
  • strictly normal pregnancies
  • complicated pregnancies of gestational diabetes, insulin-treated or not
  • complicated pregnancies due to pregnancy cholestasis
  • spontaneous or in vitro fecondation (IVF) / Intracytoplasmic sperm injection (ICSI) pregnancies with or without oocyte donation

You may not qualify if:

  • Patient's opposition
  • Age \< 18 years old
  • Women under the protection of justice
  • Multiple pregnancy
  • Known major fetal malformation
  • Pre-eclampsia and intrauterine growth retardation
  • Placental insertionnomaly
  • Type 1 diabetes
  • HIV-positive patient with HIV/hepatisis C virus (HCV) regardless of viral load
  • Patient in labour at the time of Caesarean section
  • Patient whose medical history results in medication being taken in pregnancy courses that may interfere with the biology of the trophoblast (immunomodulators in case of autoimmune diseases, anti-rejection drugs in case of transplant patients)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

RECRUITING

Central Study Contacts

camille JUNG, MD

CONTACT

00157022268camille.jung@chicreteil.fr

Study Design

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

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 11, 2019

Study Start

March 20, 2019

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)