Routine Ultrasound Screening in the Third Trimester (RECRET)
This study is currently recruiting participants.
Verified June 2012 by University Hospital, Rouen
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01594463
First received: April 27, 2012
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. The investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.
| Condition | Intervention |
|---|---|
|
Fetal Growth Retardation High-Risk Pregnancy |
Other: ultrasound examination |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction |
Further study details as provided by University Hospital, Rouen:
Primary Outcome Measures:
- Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity). [ Time Frame: At birth ] [ Designated as safety issue: No ]SGA infant and intrauterine growth restriction are defined using a threshold below the tenth percentile for customized birth weight or customized estimated birth weight.
Secondary Outcome Measures:
- Number of neonate with a customized birth weight upper the tenth percentile adequately screened by a routine ultrasound in the third trimester (specificity). [ Time Frame: At birth ] [ Designated as safety issue: No ]
- Number of prenatal consultations, ultrasound scans performed, maternal hospitalization, labor induction, and caesarean section induced by the third trimester routine ultrasound [ Time Frame: After the delivery ] [ Designated as safety issue: No ]
- Maternal complications and neonatal outcomes. [ Time Frame: In the postpartum period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4134 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: late ultrasound examination
late examination between 34+1 weeks to 35+6 weeks.
|
Other: ultrasound examination
ultrasound examination between 34+1 weeks to 35+6 weeks
|
|
Experimental: early ultrasound examination
early examination between 30+1 weeks to 31+6 weeks
|
Other: ultrasound examination
ultrasound examination between week 30+1 weeks to 31+6 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Accurate gestational dating using crown-rump length at 11-14 weeks
- Singleton pregnancy
- Primiparity
- Normal First trimester (11-14 weeks) and second trimester (20-25 weeks) scans
- Maternal age > 18 years
- No maternal opposition for the study
Exclusion Criteria:
- Maternal diseases i.e. chronic renal disease, hypertension, diabetes, collagen vascular disease, antiphospholipid syndrome
- Pregnancies with congenital anomalies or foetal growth restriction diagnosed before 30 weeks of gestation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594463
Contacts
| Contact: Eric VERSPYCK, MD, PhD | 00332888745 | eric.verspyck@chu-rouen.fr |
Locations
| France | |
| Rouen University Hospital | Recruiting |
| Rouen, France, 76031 | |
| Contact: Eric Verspyck, MD, PhD 00332888745 eric.verspyck@chu-rouen.fr | |
| Principal Investigator: Eric VERSPYCK, MD PhD | |
| Sub-Investigator: Gérard LABADIE, MD | |
| Sub-Investigator: Marie BRASSEUR-DAUDRUY, MD | |
| Sub-Investigator: Véronique WILMORT, MD | |
| Sub-Investigator: Sophie DEGRE, MD | |
| Sub-Investigator: Marie-Noëlle PLAGNOL, MD | |
| Sub-Investigator: Caroline BLONDEL-MEUNIER, MD | |
| Sub-Investigator: Philippe LEBOULLENGER, MD | |
| Sub-Investigator: Stéphanie HARDEMAN, MD | |
Sponsors and Collaborators
University Hospital, Rouen
More Information
No publications provided
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT01594463 History of Changes |
| Other Study ID Numbers: | 2010/090/HP |
| Study First Received: | April 27, 2012 |
| Last Updated: | June 13, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Rouen:
|
Intrauterine growth restriction Screening Ultrasound Perinatal morbidity Maternal complications |
Additional relevant MeSH terms:
|
Fetal Growth Retardation Fetal Diseases Pregnancy Complications Growth Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013