Fetal Growth RetardationRECRETNCT01594463
Routine Ultrasound Screening in the Third Trimester
A study testing ultrasound examination in people with Fetal Growth Retardation and High-Risk Pregnancy, run by University Hospital, Rouen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fetal Growth Retardation, High-Risk Pregnancy
- What is being tested?
- ultrasound examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,760 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Mar 2016
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction
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.
- Conditions
- Fetal Growth Retardation, High-Risk Pregnancy
- Being tested
- ultrasound examination
- Keywords
- Intrauterine growth restriction, Screening, Ultrasound, Perinatal morbidity, Maternal complications
- 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.
ultrasound examinationOther
ultrasound examination between week 30+1 weeks to 31+6 weeks
ultrasound examinationOther
ultrasound examination between 34+1 weeks to 35+6 weeks
| Study group | Role | What they receive |
|---|---|---|
| late ultrasound examination | Experimental | late examination between 34+1 weeks to 35+6 weeks. Receives: Other: ultrasound examination |
| early ultrasound examination | Experimental | early examination between 30+1 weeks to 31+6 weeks Receives: Other: ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
SGA infant and intrauterine growth restriction are defined using a threshold below the tenth percentile for customized birth weight or customized estimated birth weight.
Measured: At birth
Secondary outcomes (3)
Number of neonate with a customized birth weight upper the tenth percentile adequately screened by a routine ultrasound in the third trimester (specificity).
Measured: At birth
Number of prenatal consultations, ultrasound scans performed, maternal hospitalization, labor induction, and caesarean section induced by the third trimester routine ultrasound
Measured: After the delivery
Maternal complications and neonatal outcomes.
Measured: In the postpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric VERSPYCK, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594463
- Sponsor's protocol ID
- 2010/090/HP
- Acronym
- RECRET
- Status last verified
- May 2016
- First submitted
- 27 Apr 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT01594463
- Acronym / sponsor ID
- RECRET / 2010/090/HP
- Conditions
- Fetal Growth Retardation, High-Risk Pregnancy
- Keywords
- Intrauterine growth restriction, Screening, Ultrasound, Perinatal morbidity, Maternal complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,760 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 May 2012 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| late ultrasound examination | Experimental | Other: ultrasound examinationlate examination between 34+1 weeks to 35+6 weeks. |
| early ultrasound examination | Experimental | Other: ultrasound examinationearly examination between 30+1 weeks to 31+6 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| ultrasound examinationultrasound examination between week 30+1 weeks to 31+6 weeks | Other | early ultrasound examination |
| ultrasound examinationultrasound examination between 34+1 weeks to 35+6 weeks | Other | late ultrasound examination |
Primary outcome
Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity).
Time frame: At birth
SGA infant and intrauterine growth restriction are defined using a threshold below the tenth percentile for customized birth weight or customized estimated birth weight.
3 secondary outcomes
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
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
Maternal complications and neonatal outcomes.
Time frame: In the postpartum period
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 12 May 2016.
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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.
Eric VERSPYCK, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound examination in people with Fetal Growth Retardation and High-Risk Pregnancy, run by University Hospital, Rouen 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 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: finished, as of the sponsor's last update on 12 May 2016. 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?
Number of small for gestational age infant screened by a routine ultrasound in the third trimester (sensitivity). (time frame: At birth). 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 12 May 2016.