Miscarriage in Second Trimester Clinical Trial
Official title:
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.
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.
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