StillbirthREPERENCT01995968
Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.
An observational study of Stillbirth and Intrauterine Growth Retardation, run by University Hospital, Grenoble at 21 sites in France.
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). Read more about this study
- Who is it for?
- Ages 24 to 42 weeks
- Conditions the study is for
- Stillbirth, Intrauterine Growth Retardation, Infant, Small for Gestational Age
- What is being tested?
- Antenatal identification of fetal growth restriction
- How many people
- 480 participants
- Where
- 21 sitesFrance
- Study dates
- Nov 2013to Dec 2015
- How long will I take part?
- 1 Week
- 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 24 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: SGA births to mothers residents in 3 French districts (Isère, Savoie and Haute-Savoie)
Who may be able to join
- 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)
Who cannot join
- Fetal deaths with date of death estimated being older than date of birth by at least 1 week
- Lethal congenital anomalies
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CH Albertville-Moutiers
Albertville, 73200
Clinique Générale Annecy
Annecy, 74000
CH Annecy
Annecy, 74374
Polyclinique de Savoie Annemasse
Annemasse, 74100
CHI Annemasse Bonneville
Bonneville, 74107
CH Bourg Saint Maurice
Bourg-Saint-Maurice, 73704
Centre Hospitalier Bourgoin Jallieu
Bourgoin, 38300
Clinique Saint Vincent de Paul Bourgoin Jallieu
Bourgoin, 38300
Hopital Femme Mere Enfant
Bron, 69677
CH Chambéry
Chambéry, 73000
Clinique des Cèdres
Échirolles, 38432
Chu Grenoble
Grenoble, 38000
Clinique Mutualiste Eaux Claires
Grenoble, 38000
Hopital Croix rousse
Lyon, 69317
Clinique Belledonne
Saint Martin D Hères, 38400
CH Saint Jean de Maurienne
Saint-Jean-de-Maurienne, 73303
CH Sud Léman Valserine
Saint-Julien-en-Genevois, 74164
Hôpitaux du Mont Blanc
Sallanches, 74700
Hôpitaux du Léman
Thonon-les-Bains, 74203
Centre Hospitalier Vienne
Vienne, 38209
Centre Hospitalier Voiron
Voiron, 38506
About this study
Official title: Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.
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.
Read the detailed 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.
- Being tested
- Antenatal identification of fetal growth restriction
- Keywords
- Stillbirth, Fetal growth restriction, Small for gestational age, Antenatal detection, Prenatal Care, Mass Screening
- Medical subject headings
- Stillbirth, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal identification of fetal growth restrictionOther
Also called Antenatal detection, Antenatal recognition, Antenatal suspicion
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Antenatal identification of fetal growth restriction | |
| 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 Receives: Other: Antenatal identification of fetal growth restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of antenatal detection of FGR
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
Measured: baseline
Secondary outcomes (2)
Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
Crude and adjusted OR and 95% confidence intervals
Measured: baseline
fetal deaths of SGA newborns with and without antenatal detection of FGR
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Prospective
- Enrolment
- 480 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Anne Ego, MD PhD, Principal investigator, University Hospital, GrenobleChristine CANS, MD PHD, Study chair, Registre Handicaps de l'Enfant et Observatoire PérinatalJennifer Zeitlin, MD PHD, Study director, INSERM U953
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995968
- Sponsor's protocol ID
- DCIC12 08
- Acronym
- REPERE
- Status last verified
- Dec 2014
- First submitted
- 8 Nov 2013
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Altman DG, Hytten FE. Intrauterine growth retardation: let's be clear about it. Br J Obstet Gynaecol. 1989 Oct;96(10):1127-32. doi: 10.1111/j.1471-0528.1989.tb03185.x. No abstract available.
PubMed 2590650Pardi G, Marconi AM, Cetin I. Placental-fetal interrelationship in IUGR fetuses--a review. Placenta. 2002 Apr;23 Suppl A:S136-41. doi: 10.1053/plac.2002.0802.
PubMed 11978072Kaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.
Baschat AA. Pathophysiology of fetal growth restriction: implications for diagnosis and surveillance. Obstet Gynecol Surv. 2004 Aug;59(8):617-27. doi: 10.1097/01.ogx.0000133943.54530.76.
PubMed 15277896Hecher 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. doi: 10.1016/0002-9378(95)90161-2.
PubMed 7631665Severi 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. doi: 10.1046/j.1469-0705.2002.00652.x.
PubMed 11896941Haws 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(Suppl 1):S5. doi: 10.1186/1471-2393-9-S1-S5.
PubMed 19426468Imdad 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(Suppl 3):S1. doi: 10.1186/1471-2458-11-S3-S1.
PubMed 21501426Alfirevic Z, Neilson JP. Doppler ultrasonography in high-risk pregnancies: systematic review with meta-analysis. Am J Obstet Gynecol. 1995 May;172(5):1379-87. doi: 10.1016/0002-9378(95)90466-2.
PubMed 7755042Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. doi: 10.1002/14651858.CD001451.
PubMed 10796263Bricker 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.
PubMed 18843617Neilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.
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. doi: 10.1046/j.1471-0528.2003.02014.x.
PubMed 12504932Thornton 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. doi: 10.1016/S0140-6736(04)16809-8.
PubMed 15302194Bais 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. doi: 10.1016/j.ejogrb.2004.01.037.
PubMed 15358457
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.
- ClinicalTrials.gov ID
- NCT01995968
- Acronym / sponsor ID
- REPERE / DCIC12 08
- Keywords
- Stillbirth, Fetal growth restriction, Small for gestational age, Antenatal detection, Prenatal Care, Mass Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- 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
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Nov 2013 (estimated)
- 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 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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGA stillbirths (Cases) | – | Other: Antenatal identification of fetal growth restrictionStillbirths, 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 |
| SGA livebirths (Controls) | – | Other: Antenatal identification of fetal growth restrictionLivebirths, 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 |
Who may qualify
- Ages
- 24 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- SGA births to mothers residents in 3 French districts (Isère, Savoie and Haute-Savoie)
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Fetal deaths with date of death estimated being older than date of birth by at least 1 week
- Lethal congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antenatal identification of fetal growth restrictionAlso: Antenatal detection, Antenatal recognition, Antenatal suspicionFGR 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 | Other | SGA livebirths (Controls), SGA stillbirths (Cases) |
Primary outcome
Rate of antenatal detection of FGR
Time frame: baseline
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
2 secondary outcomes
Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
Time frame: baseline
fetal deaths of SGA newborns with and without antenatal detection of FGR
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Background: PubMed 2590650Altman DG, Hytten FE. Intrauterine growth retardation: let's be clear about it. Br J Obstet Gynaecol. 1989 Oct;96(10):1127-32. doi: 10.1111/j.1471-0528.1989.tb03185.x. No abstract available.
- Background: PubMed 11978072Pardi G, Marconi AM, Cetin I. Placental-fetal interrelationship in IUGR fetuses--a review. Placenta. 2002 Apr;23 Suppl A:S136-41. doi: 10.1053/plac.2002.0802.
- BackgroundKaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.
- Background: PubMed 15277896Baschat AA. Pathophysiology of fetal growth restriction: implications for diagnosis and surveillance. Obstet Gynecol Surv. 2004 Aug;59(8):617-27. doi: 10.1097/01.ogx.0000133943.54530.76.
- Background: PubMed 7631665Hecher 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. doi: 10.1016/0002-9378(95)90161-2.
- Background: PubMed 11896941Severi 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. doi: 10.1046/j.1469-0705.2002.00652.x.
- Background: PubMed 19426468Haws 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(Suppl 1):S5. doi: 10.1186/1471-2393-9-S1-S5.
- Background: PubMed 21501426Imdad 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(Suppl 3):S1. doi: 10.1186/1471-2458-11-S3-S1.
- Background: PubMed 7755042Alfirevic Z, Neilson JP. Doppler ultrasonography in high-risk pregnancies: systematic review with meta-analysis. Am J Obstet Gynecol. 1995 May;172(5):1379-87. doi: 10.1016/0002-9378(95)90466-2.
- Background: PubMed 10796263Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. doi: 10.1002/14651858.CD001451.
- Background: PubMed 18843617Bricker 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.
- BackgroundNeilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.
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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 Ego, MD PhD principal investigator
University Hospital, Grenoble
Christine CANS, MD PHD study chair
Registre Handicaps de l'Enfant et Observatoire Périnatal
Jennifer Zeitlin, MD PHD study director
INSERM U953
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stillbirth and Intrauterine Growth Retardation, run by University Hospital, Grenoble at 21 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Results are not available in the source record.
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?
Rate of antenatal detection of FGR (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995968, which also lists 20 linked publications.
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 4 Aug 2015.