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Pregnancy Loss Between 15 and 22 Weeks SA Within the Network of Perinatal Pérriodof Western Brittany : Case Control Study PILOT STUDY CA (PEGREP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668743
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease
Miscarriage in Second Trimester

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Study Type : Observational
Actual Enrollment : 202 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Pregnancy Loss Between 15 and 22 Weeks SA Within the Network of Perinatal Period of Western Brittany : Case Control Study
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017



Primary Outcome Measures :
  1. maternal history [ Time Frame: at the time of diagnosis of fetal loss (Day1) ]
    chronic diseases, history of gynecology and obstetrics

  2. criteria of the pregnancy concerned by the fetal loss [ Time Frame: at the time of diagnosis of fetal loss ( Day 1) ]
    pregnancy after infertility treatment, antenatal invasiveness, 1st trimester, premature bleeding, gestational diabètes, rupture of membranes



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668743


Locations
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France
SALAUN Anne -Laure
Brest, France, 29200
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Anne-Laure SALAUN University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03668743    
Other Study ID Numbers: PEGREP (29BRC17.0056)
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
risk factor
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications