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

Miscarriage in Second Trimester Clinical Trial

— PEGREP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668743
• Other study ID #: PEGREP (29BRC17.0056)
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: May 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage in Second Trimester

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	SALAUN Anne -Laure	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal history	chronic diseases, history of gynecology and obstetrics	at the time of diagnosis of fetal loss (Day1)
Primary	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)