NCT03668184

Brief Summary

The main goal is to determine which risk factors develop preeclampsia in this specific group of oocyte recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

January 2, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

September 6, 2018

Last Update Submit

April 11, 2023

Conditions

PregnancyOocyte Donation

Outcome Measures

Primary Outcomes (1)

  • occurrence of pre-eclampsia

    through study completion, an average of 1 year

Interventions

preeclampsiaOTHER

occurrence of pre-eclampsia

Eligibility Criteria

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

Patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation.

You may qualify if:

  • All major patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation in one of the study centers, having given birth between January 2010 and April 2017 and not opposed to participation in the study.

You may not qualify if:

  • all pregnancies resulting from an oocyte donation abroad, persons of legal age subject to legal protection (safeguard of justice, guardianship, tutorship) and persons deprived of their liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Rennes

Rennes, 35033, France

Location

Clinique de la sagesse

Rennes, 35043, France

Location

Study Officials

  • Solène DUROS, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 12, 2018

Study Start

January 2, 2018

Primary Completion

April 27, 2018

Study Completion

April 27, 2018

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

FR(2)