Miscarriage in Second TrimesterPEGREPNCT03668743
Pregnancy Loss Between 15 and 22 Weeks SA Within the Network of Perinatal Pérriodof Western Brittany : Case Control Study PILOT STUDY CA
An observational study of Miscarriage in Second Trimester, run by University Hospital, Brest at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Miscarriage in Second Trimester
- How many people
- 202 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2017to 1 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Miscarriage in Second Trimester
- Keywords
- risk factor
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal history
chronic diseases, history of gynecology and obstetrics
Measured: 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
Measured: at the time of diagnosis of fetal loss ( Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Jun 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscarriage in Second TrimesterStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure SALAUN, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668743
- Sponsor's protocol ID
- PEGREP (29BRC17.0056)
- Acronym
- PEGREP
- Status last verified
- May 2017
- First submitted
- 11 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Loss Between 15 and 22 Weeks SA Within the Network of Perinatal Period of Western Brittany : Case Control Study
- ClinicalTrials.gov ID
- NCT03668743
- Acronym / sponsor ID
- PEGREP / PEGREP (29BRC17.0056)
- Conditions
- Miscarriage in Second Trimester
- Keywords
- risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
maternal history
Time frame: at the time of diagnosis of fetal loss (Day1)
chronic diseases, history of gynecology and obstetrics
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Laure SALAUN principal investigator
University Hospital, Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage in Second Trimester, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal history (time frame: at the time of diagnosis of fetal loss (Day1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.