Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction Clinical Trial
— REDIFFOfficial title:
Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.
| Verified date | April 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | October 17, 2019 |
| Est. primary completion date | October 29, 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Armand Trousseau | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Boers 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. — View Citation
Boyer AC, Gonçalves 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. — View Citation
Jouannic 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 — 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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Poor neonatal status | Neonatal death; Apgar score < 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH < 7.10 | At birth | |
| Secondary | 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 | until 30 days of life | |
| Secondary | Neonatal status at neonatology unit discharge | Neurological status: normal / abnormal; need in O2: Yes/No | up to 20 weeks | |
| Secondary | Neurological development | Age and stages questionnaire (ASQ) | At 2 years of age (adjusted age) |