Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.

Infant, Small for Gestational Age Clinical Trial

— REPERE  

Official title:

Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01995968
• Other study ID #: DCIC12 08
• Status: Active, not recruiting
• Phase: N/A
• First received: November 8, 2013
• Last updated: July 31, 2015
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 42 Weeks

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Infant, Small for Gestational Age
• Intrauterine Growth Retardation
• Stillbirth

Intervention

Other:
• Antenatal identification of fetal growth restriction
FGR is considered as "identified" if: FGR was mentioned in medical charts OR at least one ultrasound fetometry had indicated an estimated fetal weight or an abdominal diameter below the 10th percentile (whatever the reference curve used) OR no (or insufficient) weight gain between two ultrasounds mentioned in medical charts OR pathological Doppler examination of the umbilical artery (absent or reversed blood flow at the end of diastole) OR utero-placental Doppler ultrasound indicated for suspicion of growth failure

Locations

Country	Name	City	State
France	CH Albertville-Moutiers	Albertville
France	CH Annecy	Annecy
France	Clinique Générale Annecy	Annecy
France	Polyclinique de Savoie Annemasse	Annemasse
France	CHI Annemasse Bonneville	Bonneville
France	CH Bourg Saint Maurice	Bourg Saint Maurice
France	Clinique Saint Vincent de Paul Bourgoin Jallieu	Bourgoin Jallieu
France	Centre Hospitalier Bourgoin Jallieu	Bourgoin-Jallieu
France	Hopital Femme Mere Enfant	Bron
France	CH Chambéry	Chambéry
France	Clinique des Cèdres	Echirolles
France	Chu Grenoble	Grenoble
France	Clinique Mutualiste Eaux Claires	Grenoble
France	Hopital Croix rousse	Lyon
France	Clinique Belledonne	Saint Martin d Hères
France	CH Saint Jean de Maurienne	Saint-Jean-de-Maurienne
France	CH Sud Léman Valserine	Saint-Julien-en-Genevois
France	Hôpitaux du Mont Blanc	Sallanches
France	Hôpitaux du Léman	Thonon-les-Bains
France	Centre Hospitalier Vienne	Vienne
France	Centre Hospitalier Voiron	Voiron

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Registre de Handicap de l’Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie, UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM

Country where clinical trial is conducted

France, 

References & Publications (20)

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Bais JM, Eskes M, Pel M, Bonsel GJ, Bleker OP. Effectiveness of detection of intrauterine growth retardation by abdominal palpation as screening test in a low risk population: an observational study. Eur J Obstet Gynecol Reprod Biol. 2004 Oct 15;116(2):164-9. — View Citation

Baschat AA. Pathophysiology of fetal growth restriction: implications for diagnosis and surveillance. Obstet Gynecol Surv. 2004 Aug;59(8):617-27. Review. — View Citation

Bricker L, Neilson JP, Dowswell T. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Cochrane Database Syst Rev. 2008 Oct 8;(4):CD001451. doi: 10.1002/14651858.CD001451.pub3. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD001451. — View Citation

Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. Review. Update in: Cochrane Database Syst Rev. 2007;(2):CD001451. Cochrane Database Syst Rev. 2008;(4):CD001451. — View Citation

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GRIT Study Group. A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation. BJOG. 2003 Jan;110(1):27-32. — View Citation

Haws RA, Yakoob MY, Soomro T, Menezes EV, Darmstadt GL, Bhutta ZA. Reducing stillbirths: screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009 May 7;9 Suppl 1:S5. doi: 10.1186/1471-2393-9-S1-S5. Review. — View Citation

Hecher K, Snijders R, Campbell S, Nicolaides K. Fetal venous, intracardiac, and arterial blood flow measurements in intrauterine growth retardation: relationship with fetal blood gases. Am J Obstet Gynecol. 1995 Jul;173(1):10-5. — View Citation

Imdad A, Yakoob MY, Siddiqui S, Bhutta ZA. Screening and triage of intrauterine growth restriction (IUGR) in general population and high risk pregnancies: a systematic review with a focus on reduction of IUGR related stillbirths. BMC Public Health. 2011 Apr 13;11 Suppl 3:S1. doi: 10.1186/1471-2458-11-S3-S1. Review. — View Citation

Jahn A, Razum O, Berle P. Routine screening for intrauterine growth retardation in Germany: low sensitivity and questionable benefit for diagnosed cases. Acta Obstet Gynecol Scand. 1998 Jul;77(6):643-8. — View Citation

Kaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.

Lindqvist PG, Molin J. Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome? Ultrasound Obstet Gynecol. 2005 Mar;25(3):258-64. — View Citation

Mattioli KP, Sanderson M, Chauhan SP. Inadequate identification of small-for-gestational-age fetuses at an urban teaching hospital. Int J Gynaecol Obstet. 2010 May;109(2):140-3. doi: 10.1016/j.ijgo.2009.11.023. Epub 2010 Feb 2. — View Citation

Neilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.

Ogundipe EM, Wolfe CD, Seed P, Gamsu HR. Does the antenatal detection of small-for-gestational-age babies influence their two-year outcomes? Am J Perinatol. 2000;17(2):73-81. — View Citation

Pardi G, Marconi AM, Cetin I. Placental-fetal interrelationship in IUGR fetuses--a review. Placenta. 2002 Apr;23 Suppl A:S136-41. Review. — View Citation

Severi FM, Bocchi C, Visentin A, Falco P, Cobellis L, Florio P, Zagonari S, Pilu G. Uterine and fetal cerebral Doppler predict the outcome of third-trimester small-for-gestational age fetuses with normal umbilical artery Doppler. Ultrasound Obstet Gynecol. 2002 Mar;19(3):225-8. — View Citation

Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of antenatal detection of FGR	Crude and adjusted OR of stillbirth according to antenatal detection of FGR	baseline	No
Secondary	Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births	Crude and adjusted OR and 95% confidence intervals	baseline	No
Secondary	fetal deaths of SGA newborns with and without antenatal detection of FGR		baseline	No