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

September 11, 2018 updated by: University Hospital, Brest

Pregnancy Loss Between 15 and 22 Weeks SA Within the Network of Perinatal Period of Western Brittany : Case Control Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The etiologies of late miscarriages are well described in the literature. Globally, these are premature deliveries, namely: malformations of the genital tract (uterine malformations, cervico-isthmic incompetence), infections (chorioamniotitis, cervico-vaginal infections) and fetal causes (hydramnios, multiple pregnancies). Some risk factors are also described as extreme maternal age (<16 years,> 35 years), social deprivation, sleep deprivation, smoking, prenatal diagnosis, Fake's antecedent Delayed diapers (FCT), premature rupture of membranes, premature delivery or conization.

The etiologies of Fetal Deaths In Utero (MFIU) are also described: placental abnormalities, funicular abnormalities, fetal-maternal haemorrhage, fetal abnormalities (malformations, aneuploidy, genetic abnormalities), infections (in particular strepto B, E. coli and toxoplasmosis).

Certain risk factors are not studied in terms of their influence on fetal loss: body mass index (BMI), existence of chronic pathologies (diabetes, thyroid diseases, depression, other chronic diseases, etc.). ..), uterine scarring, uterine endoscopic surgery ATCD, sterility treatment (induction of ovulation, procreation medical assistance (MPA) type insemination or IVF, 1st trimester bleeding, prenatal diagnosis procedure (amniocentesis or biopsy trophoblast).

population concerned: Patients who had a pregnancy loss between 15 and 22 SA between 2010 and 2015, listed thanks to the data sheets of the Western Brittany Perinatal Network

Main objective: To identify risk factors for pregnancy loss between 15 SA and 22 SA.

main endpoint: BMI, existence of chronic pathologies (diabetes, thyroid pathologies, depression, other chronic diseases .....), treatments, uterine scarring, antecedent of uterine endoscopic surgery, treatment of infertility (induction of ovulation, medical assistance in procreation (MPA) type insemination or IVF), first trimester bleeding, prenatal diagnosis procedure (amniocentesis or trophoblast biopsy).

Methodology: Retrospective multicenter case-control study. Pairing 1 case for 1 witnesses. Match with age, parity, number of fetuses (single or multiple pregnancy)

Statistics: A typical descriptive analysis will be performed (means and standard deviation, medians and quartiles, proportions). Comparisons will be performed univarially by a matched Chi-square for proportions, a paired Student T-test if normal distribution or a matched non-parametric test (matched Willcoxon test) if non-normal distribution. Then a multivariate analysis will be performed using conditional logistic regression.

Criteria for inclusion:

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.

Number of patients: 101 cases, 101 controls. The number of cases identified is 101, and the number of controls is set at 101 (1: 1).

Expected benefits: This study will identify or suggest high-intensity risk factors (OR> 4); but the study will not be powerful enough to identify possible factors of lesser intensity (OR <2). These preliminary results will lead to the subsequent development of a prospective study adjusted to specific and quantified hypotheses in order to establish an adequate number of necessary subjects.

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest
      • Brest, France, 29200
        • SALAUN Anne -Laure

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maternal history
Time Frame: at the time of diagnosis of fetal loss (Day1)
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
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
at the time of diagnosis of fetal loss ( Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Anne-Laure SALAUN, University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (ACTUAL)

September 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEGREP (29BRC17.0056)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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