NCT03668743

Brief Summary

The etiologies and some risk factors for pregnancy loss in the 2nd trimester are described in the literature. However, there are some risk factors that are not studied. The PEGREP study is a retrospective observational case-control study whose main objective is to identify risk factors for pregnancy loss between 15 and 22 weeks. The patients included cases are women who had a pregnancy loss between 15 and 22 SA between 2010 and 2015 and who were listed during the mortality reviews of the perinatal network of Western Brittany. The patient witnesses gave birth at the end of a healthy child in one of the maternity of Western Brittany. Matching 1 case for 1 controls was done on the woman's age, parity and number of fetuses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

September 11, 2018

Last Update Submit

September 11, 2018

Conditions

Keywords

risk factor

Outcome Measures

Primary Outcomes (2)

  • maternal history

    chronic diseases, history of gynecology and obstetrics

    at the time of diagnosis of fetal loss (Day1)

  • criteria of the pregnancy concerned by the fetal loss

    pregnancy after infertility treatment, antenatal invasiveness, 1st trimester, premature bleeding, gestational diabètes, rupture of membranes

    at the time of diagnosis of fetal loss ( Day 1)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who had a loss of pregnancy between 15 and 22 SA between 2010 and 2015, listed thanks to the data sheets of the perinatal network of Western Brittany

You may qualify if:

  • CAS:
  • patients who had a pregnancy loss between 15 and 22 SA between 2010 and 2015
  • having given birth in one of the maternities of Western Brittany
  • listed during the mortality reviews of the perinatal network of Western Brittany.
  • WITNESSES:
  • patients who have given birth (\> 37SA) of healthy children
  • having given birth in one of the maternity of Western Brittany. Pairing: Age, parity, number of fetuses (single or multiple pregnancy). Pairing 1 case for 1 witnesses.
  • Listed at Brest CHRU

You may not qualify if:

  • Pregnancy loss after 22 weeks,
  • medical or therapeutic interruptions of pregnancy,
  • fetuses whose anatomopathology describes biometrics below 15SA,
  • fetuses with chromosomal malformations or abnormalities diagnosed before pregnancy loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SALAUN Anne -Laure

Brest, 29200, France

Location

CHRU de Brest

Brest, 29609, France

Location

Study Officials

  • Anne-Laure SALAUN

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 13, 2018

Study Start

June 1, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

September 13, 2018

Record last verified: 2017-05

Locations