Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate. (REPERE)
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| ClinicalTrials.gov Identifier: NCT01995968 |
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Recruitment Status : Unknown
Verified December 2014 by University Hospital, Grenoble.
Recruitment status was: Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : August 4, 2015
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The main objective is to assess the role of antenatal detection of fetal growth restriction (FGR) on stillbirth, by a case-control study in a population-based sample of small for gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of French customised birth weight curves.
Our secondary objectives are
- to identify determinants of antenatal detection of FGR among a representative sample of SGA births, with a special interest in the definition of FGR. Our hypothesis is that births who are SGA by customised birthweight curves and non-SGA by population birthweight curves, are not detected antenatally, despite the current strategy including the use of umbilical Doppler.
- to analyse prenatal care of a subsample of SGA stillbirths with and without detection of FGR by a confidential enquiry.
| Condition or disease | Intervention/treatment |
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| Stillbirth Intrauterine Growth Retardation Infant, Small for Gestational Age | Other: Antenatal identification of fetal growth restriction |
Stillbirths will be identified by the RHEOP (Registre des Handicaps de l'Enfant et Observatoire Périnatal).
The RHEOP was created in 1988 in the Isère district in the Rhône-Alpes region of France. The area covered by the registry was enlarged to include two contiguous districts in 2005 (Savoie and Haute-Savoie). This registry includes all cases of childhood disability as well as all stillbirths to residents in these districts. Its objective is to monitor the trends in stillbirth and chid disability, and to identify conditions associated with these events. The three participating districts constitute a population-based sample of 30 000 births per year. The RHEOP registry uses the WHO definition of a stillbirth, i.e., "the birth of a baby with a birth weight of 500 g or 22 or more completed weeks of gestation who died before or during labor and birth". Its completeness is checked by matching its database with three data sources : results of placental examination and fetal autopsy, adjacent register of fetal anomalies, and regional reference center for prenatal diagnosis.
Stillbirths are identified in maternity hospitals thanks to collaborating midwifes and routinely collected data. Several specific investigators, who are trained nurses, midwives or physicians, complete a standardized form based on the medical record for each case.
For the purpose of the project, additional data will be collected allowing to describe prenatal care including ultrasound and Doppler examinations, and obstetrical management. Healthcare professionals (GP, midwife, obstetricians and gynecologists) will be solicited if data are missing in maternity medical records. SGA stillbirths in 2012 and 2013 will be included.
Consecutive SGA livebirths to residents in Isère, Savoie and Haute-Savoie, will be identified by the same way. Two months (probably october and november 2013)are approximately needed to record the sample size of controls.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 480 participants |
| Observational Model: | Case Control |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Week |
| Official Title: | Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate. |
| Study Start Date : | November 2013 |
| Actual Primary Completion Date : | July 2015 |
| Estimated Study Completion Date : | December 2015 |
| Group/Cohort | Intervention/treatment |
|---|---|
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SGA stillbirths (Cases)
Stillbirths, SGA births (below the 10th percentile of French customised birthweight curves), born in 2012-13, at or after 24 completed weeks of gestational age, without lethal congenital anomalies, to mothers residents in Isère, Savoie or Haute-Savoie
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Other: Antenatal identification of fetal growth restriction
FGR is considered as "identified" if:
Other Names:
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SGA livebirths (Controls)
Livebirths, SGA births (below the 10th percentile of French customised birthweight curves), born in 2013, at or after 24 completed weeks of gestational age, without lethal congenital anomalies, to mothers residents in Isère, Savoie or Haute-Savoie
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Other: Antenatal identification of fetal growth restriction
FGR is considered as "identified" if:
Other Names:
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- Rate of antenatal detection of FGR [ Time Frame: baseline ]Crude and adjusted OR of stillbirth according to antenatal detection of FGR
- Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births [ Time Frame: baseline ]Crude and adjusted OR and 95% confidence intervals
- fetal deaths of SGA newborns with and without antenatal detection of FGR [ Time Frame: baseline ]
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| Ages Eligible for Study: | 24 Weeks to 42 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
Births:
- Stillbirths (antepartum or intrapartum fetal death) (=Cases) or livebirths (=Controls)
- at or after 24 completed weeks of gestational age
- singletons
- to mothers residents in 1 of the 3 districts (Isère, Savoie, Haute-Savoie) of the RHEOP register
- SGA: birthweight below the 10th percentile of French customised birthweight curves)
Exclusion Criteria:
- Fetal deaths with date of death estimated being older than date of birth by at least 1 week
- Lethal congenital anomalies
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): NCT01995968
Show 21 study locations
| Principal Investigator: | Anne Ego, MD PhD | University Hospital, Grenoble | |
| Study Chair: | Christine CANS, MD PHD | Registre Handicaps de l'Enfant et Observatoire Périnatal | |
| Study Director: | Jennifer Zeitlin, MD PHD | INSERM U953 |
Publications:
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT01995968 |
| Other Study ID Numbers: |
DCIC12 08 |
| First Posted: | November 27, 2013 Key Record Dates |
| Last Update Posted: | August 4, 2015 |
| Last Verified: | December 2014 |
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Stillbirth Fetal growth restriction Small for gestational age |
Antenatal detection Prenatal Care Mass Screening |
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Stillbirth Fetal Growth Retardation Fetal Death Pregnancy Complications |
Death Pathologic Processes Fetal Diseases Growth Disorders |