Pregnant Women With Foetuses Presenting With Intra-uterine Growth RestrictionREDIFFNCT02229630
Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.
A study testing Pregnant women with intra-uterine growth restricted Foetuses in people with Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to compare the apparent diffusion coefficient in the frontal lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared with foetuses with intra-uterine growth restriction and a good neonatal outcome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction
- What is being tested?
- Pregnant women with intra-uterine growth restricted Foetuses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2015to 17 Oct 2019
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single pregnancy
- estimated foetal weight ≤ 5th percentile
- agreeing to participate
- women age ≥ 18 years of age, speaking and understanding French language
- covered by the French social security system
Who cannot join
- foetal malformation or foetal karyotype abnormal
- infectious foetopathy
- multiple pregnancy
- refusal to participate
- pregnant women aged < 18 years old
- pregnant women not understanding or speaking French language
- not covered by French social security
- contraindication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.
The purpose of this study is to compare the apparent diffusion coefficient in the frontal lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared with foetuses with intra-uterine growth restriction and a good neonatal outcome.
Read the detailed description
Intra-uterine growth restriction is associated with an increased risk of perinatal morbimortality. The objective of foetal monitoring is to assess foetal growth, foetal well-being and to evaluate ability to adapt to chronic hypoxia.
The primary objective in antenatal care is to ischemic cerebral lesions. However, there is currently no relevant prenatal exam predictive for the risk of such lesions.
Foetal cerebral MRI could highlight changes in Apparent Diffusion Coefficient (ADC) in some frontal cerebral territories in foetuses with intra-uterine growth restriction and poor neonatal outcome.
These changes could be associated with a transient cerebral ischemia. The study of ADC could be a useful tool in the prognostic evaluation of these foetuses.
- Being tested
- Pregnant women with intra-uterine growth restricted Foetuses
- Keywords
- intra-uterine growth restriction, MRI, apparent diffusion coefficient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant women with intra-uterine growth restricted FoetusesRadiation
Also called cerebral MRI
Diffusion-weighted cerebral MRI before 32 weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Experimental | Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight < 5th percentile (Hadlock calculator) Receives: Radiation: Pregnant women with intra-uterine growth restricted Foetuses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor neonatal status
Neonatal death; Apgar score < 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH < 7.10
Measured: At birth
Secondary outcomes (3)
Poor neonatal status
Necrositing enterocolitis with need for surgical intervention; convulsions; intraventricular haemorrhage (type I to IV); periventricular leukomalacia (diagnosed by MRI); transfer to neonatal intensive care unit
Measured: until 30 days of life
Neonatal status at neonatology unit discharge
Neurological status: normal / abnormal; need in O2: Yes/No
Measured: up to 20 weeks
Neurological development
Age and stages questionnaire (ASQ)
Measured: At 2 years of age (adjusted age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study start11 Mar 2015
- Primary completion29 Oct 2017
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnant Women With Foetuses Presenting With Intra-uterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Jouannic, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229630
- Sponsor's protocol ID
- P130915
- Other IDs
- IDRCB: 2014-A00640-47
- Acronym
- REDIFF
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2014
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/S0140-6736(04)16809-8.
PubMed 15302194Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA; DIGITAT study group. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ. 2010 Dec 21;341:c7087. doi: 10.1136/bmj.c7087.
PubMed 21177352Boyer AC, Goncalves LF, Lee W, Shetty A, Holman A, Yeo L, Romero R. Magnetic resonance diffusion-weighted imaging: reproducibility of regional apparent diffusion coefficients for the normal fetal brain. Ultrasound Obstet Gynecol. 2013 Feb;41(2):190-7. doi: 10.1002/uog.11219. Epub 2013 Jan 3.
PubMed 22744761Xu E, Jouannic JM, Alison M, Ancel PY, Friszer S, Rousseau J, Guilbaud L, Adamsbaum C, Goffinet F, Blondiaux E. Analysis of MRI brain biometrics in fetuses monitored for intra uterine growth restriction and their prognostic value: Results of a prospective multicenter study. Eur J Obstet Gynecol Reprod Biol. 2024 Jul;298:91-97. doi: 10.1016/j.ejogrb.2024.04.043. Epub 2024 Apr 30.
PubMed 38735121Jouannic JM, Blondiaux E, Senat MV, Friszer S, Adamsbaum C, Rousseau J, Hornoy P, Letourneau A, de Laveaucoupet J, Lecarpentier E, Rosenblatt J, Quibel T, Mollot M, Ancel PY, Alison M, Goffinet F. Prognostic value of diffusion-weighted magnetic resonance imaging of brain in fetal growth restriction: results of prospective multicenter study. Ultrasound Obstet Gynecol. 2020 Dec;56(6):893-900. doi: 10.1002/uog.21926.
PubMed 31765031
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.
- ClinicalTrials.gov ID
- NCT02229630
- Acronym / sponsor ID
- REDIFF / P130915
- Keywords
- intra-uterine growth restriction, MRI, apparent diffusion coefficient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- 29 Oct 2017 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 1 Sep 2014 (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 purpose of this study is to compare the apparent diffusion coefficient in the frontal lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared with foetuses with intra-uterine growth restriction and a good neonatal outcome.
Detailed description
Intra-uterine growth restriction is associated with an increased risk of perinatal morbimortality. The objective of foetal monitoring is to assess foetal growth, foetal well-being and to evaluate ability to adapt to chronic hypoxia.
The primary objective in antenatal care is to ischemic cerebral lesions. However, there is currently no relevant prenatal exam predictive for the risk of such lesions.
Foetal cerebral MRI could highlight changes in Apparent Diffusion Coefficient (ADC) in some frontal cerebral territories in foetuses with intra-uterine growth restriction and poor neonatal outcome.
These changes could be associated with a transient cerebral ischemia. The study of ADC could be a useful tool in the prognostic evaluation of these foetuses.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Radiation: Pregnant women with intra-uterine growth restricted FoetusesFoetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight < 5th percentile (Hadlock calculator) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- single pregnancy
- estimated foetal weight ≤ 5th percentile
- agreeing to participate
- women age ≥ 18 years of age, speaking and understanding French language
- covered by the French social security system
Key exclusion criteria (8 listed)
- foetal malformation or foetal karyotype abnormal
- infectious foetopathy
- multiple pregnancy
- refusal to participate
- pregnant women aged < 18 years old
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 |
|---|---|---|
| Pregnant women with intra-uterine growth restricted FoetusesAlso: cerebral MRIDiffusion-weighted cerebral MRI before 32 weeks of gestation | Radiation | Pregnant women |
Primary outcome
Poor neonatal status
Time frame: At birth
Neonatal death; Apgar score < 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH < 7.10
3 secondary outcomes
Poor neonatal status
Time frame: until 30 days of life
Neonatal status at neonatology unit discharge
Time frame: up to 20 weeks
Neurological development
Time frame: At 2 years of age (adjusted age)
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 8 Sep 2025.
- Background: PubMed 15302194Thornton 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.
- Background: PubMed 21177352Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA; DIGITAT study group. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ. 2010 Dec 21;341:c7087. doi: 10.1136/bmj.c7087.
- Background: PubMed 22744761Boyer AC, Goncalves LF, Lee W, Shetty A, Holman A, Yeo L, Romero R. Magnetic resonance diffusion-weighted imaging: reproducibility of regional apparent diffusion coefficients for the normal fetal brain. Ultrasound Obstet Gynecol. 2013 Feb;41(2):190-7. doi: 10.1002/uog.11219. Epub 2013 Jan 3.
- Results publication: PubMed 38735121Xu E, Jouannic JM, Alison M, Ancel PY, Friszer S, Rousseau J, Guilbaud L, Adamsbaum C, Goffinet F, Blondiaux E. Analysis of MRI brain biometrics in fetuses monitored for intra uterine growth restriction and their prognostic value: Results of a prospective multicenter study. Eur J Obstet Gynecol Reprod Biol. 2024 Jul;298:91-97. doi: 10.1016/j.ejogrb.2024.04.043. Epub 2024 Apr 30.
- Results publication: PubMed 31765031Jouannic JM, Blondiaux E, Senat MV, Friszer S, Adamsbaum C, Rousseau J, Hornoy P, Letourneau A, de Laveaucoupet J, Lecarpentier E, Rosenblatt J, Quibel T, Mollot M, Ancel PY, Alison M, Goffinet F. Prognostic value of diffusion-weighted magnetic resonance imaging of brain in fetal growth restriction: results of prospective multicenter study. Ultrasound Obstet Gynecol. 2020 Dec;56(6):893-900. doi: 10.1002/uog.21926.
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.
Jean-Marie Jouannic, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnant women with intra-uterine growth restricted Foetuses in people with Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 8 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 8 Sep 2025. 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?
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?
Poor neonatal status (time frame: At birth). 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 NCT02229630, which also lists 5 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 8 Sep 2025.