Intrauterine Growth RestrictionIUGRNCT03866863
Intra Uterine Growth Restriction
An observational study of Intrauterine Growth Restriction, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Intrauterine growth restriction (IUGR) is associated with an increase in perinatal mortality and morbidity, as well as longer-term neurological, cognitive, cardiovascular and endocrine complications. In Europe, about 400,000 pregnancies per year are complicated by IUGR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- Intrauterine growth restriction (IUGR)
- How many people
- 31,052 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to Apr 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2017.
Who may be able to join
- All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
- from 1st of january 2011 to 31 december 2017.
Who cannot join
- Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant .
- Multiple pregnancies,
- children with congenital fetal anomalies
- pregnancies without first trimester ultrasound (to date the pregnancy)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Femme Mère Enfant
Bron
Muriel Doret, Prof.
Muriel Doret, Prof.
About this study
Official title: Intra Uterine Growth Restriction. Minimum Required Evidence-based Care and Neonatal Prognosis: Impact of Healthcare Pathways
Intrauterine growth restriction (IUGR) is associated with an increase in perinatal mortality and morbidity, as well as longer-term neurological, cognitive, cardiovascular and endocrine complications. In Europe, about 400,000 pregnancies per year are complicated by IUGR. However, antenatal diagnosis seems insufficient in clinical practice, making it impossible to recognize up to 75% of foetuses with IUGR. At a time when the use of good clinical practice has demonstrated a significant improvement in neonatal survival without severe morbidity, foetuses with IUGR are less likely to receive optimal care. Our hypothesis is that the rate of IUGR diagnosed underestimates the rate of actual IUGR.
- Conditions
- Intrauterine Growth Restriction
- Being tested
- Intrauterine growth restriction (IUGR)
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine growth restriction (IUGR)Other
Collection of number of patient's diagnosed with IUGR as defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth.
| Study group | Role | What they receive |
|---|---|---|
| HFME births. | All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2017. Receives: Other: Intrauterine growth restriction (IUGR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients diagnosed with Intrauterine growth restriction
IUGR was defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth.
Measured: Between 2011 and 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Sep 2018
- Primary completion1 Apr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31,052 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muriel DORET, Prof., Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866863
- Sponsor's protocol ID
- IUGR
- Acronym
- IUGR
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 13 Mar 2019
- 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 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Uterine Growth Restriction. Minimum Required Evidence-based Care and Neonatal Prognosis: Impact of Healthcare Pathways
- ClinicalTrials.gov ID
- NCT03866863
- Acronym / sponsor ID
- IUGR / IUGR
- Conditions
- Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31,052 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 7 Mar 2019 (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.
Intrauterine growth restriction (IUGR) is associated with an increase in perinatal mortality and morbidity, as well as longer-term neurological, cognitive, cardiovascular and endocrine complications. In Europe, about 400,000 pregnancies per year are complicated by IUGR. However, antenatal diagnosis seems insufficient in clinical practice, making it impossible to recognize up to 75% of foetuses with IUGR. At a time when the use of good clinical practice has demonstrated a significant improvement in neonatal survival without severe morbidity, foetuses with IUGR are less likely to receive optimal care. Our hypothesis is that the rate of IUGR diagnosed underestimates the rate of actual IUGR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFME births. | – | Other: Intrauterine growth restriction (IUGR)All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2017. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2017.
Key inclusion criteria (2 listed)
- All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
- from 1st of january 2011 to 31 december 2017.
Key exclusion criteria (4 listed)
- Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant .
- Multiple pregnancies,
- children with congenital fetal anomalies
- pregnancies without first trimester ultrasound (to date the pregnancy)
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 |
|---|---|---|
| Intrauterine growth restriction (IUGR)Collection of number of patient's diagnosed with IUGR as defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth. | Other | HFME births. |
Primary outcome
Number of patients diagnosed with Intrauterine growth restriction
Time frame: Between 2011 and 2017
IUGR was defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Muriel DORET, Prof. principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction, run by Hospices Civils de Lyon at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Muriel DORET, Prof. (4 27 85 51 70 ext. 33, muriel.doret-dion@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients diagnosed with Intrauterine growth restriction (time frame: Between 2011 and 2017). 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 Mar 2019.