PregnancyUSmacroNCT04443205
Relevance of Ultrasound Screening for Foetal Macrosomia
An observational study of Pregnancy, run by CHU de Reims at 1 site in France.
Trial summary
Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Data record
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2020to Dec 2021
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women
Who may be able to join
- Women pregnant Women followed in the gynaecology and obstetrics department of the CHU of Reims, the CHG of Charleville Mézières or the CHG of Chalons en Champagne.
- Women for which the delivery is planned in the gynaecology and obstetrics department of the Reims University Hospital, the Charleville Mézières General Hospital or the Chalons en Champagne General Hospital.
- Non-inclusion criteria Women without ultrasound dating scan in the first trimester. Women having a contraindication to labour or vaginal delivery Women with a scarred uterus Women having a history of shoulder dystocia or obstetric trauma Women having a history of urinary or fecal incontinence Women having a history of bad birth experience with high psychological impact Women with maternal pathologies (excluding gestational diabetes) Women whose fetus is breech Women with twin pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Damien JOLLY
Reims
Uzma ISHAQUE, 03 10 73 62 88 ext. 0033, uishaque@chu-reims.fr
About this study
Official title: Relevance of Ultrasound Screening for Foetal Macrosomia and Description of Its Management in Champagne-Ardenne
Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.
Read the detailed description
The aim of the study is to describe management of women whose child is macrosomal but has not been screened g using ultrasound during the third trimester of pregnancy.
- Conditions
- Pregnancy
- Being tested
- Data record
- Keywords
- Fetal Macrosomia, Ultrasound, Shoulder Dystocia, induction of labour, Cesarean
- Medical subject headings
- Fetal Macrosomia, Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recordOther
Data record
| Study group | Role | What they receive |
|---|---|---|
| no macrosomy | pregnant women whose child is not macrosomal Receives: Other: Data record | |
| screened macrosomy | pregnant women whose child is macrosomal and have been screened g using ultrasound during the third trimester of pregnancy Receives: Other: Data record | |
| no screened macrosomy | pregnant women whose child is macrosomal and havenot been screened g using ultrasound during the third trimester of pregnancy Receives: Other: Data record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foetal macrosomia
estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443205
- Sponsor's protocol ID
- PO20090
- Acronym
- USmacro
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Ultrasound Screening for Foetal Macrosomia and Description of Its Management in Champagne-Ardenne
- ClinicalTrials.gov ID
- NCT04443205
- Acronym / sponsor ID
- USmacro / PO20090
- Conditions
- Pregnancy
- Keywords
- Fetal Macrosomia, Ultrasound, Shoulder Dystocia, induction of labour, Cesarean
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Jun 2020 (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.
Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.
Detailed description
The aim of the study is to describe management of women whose child is macrosomal but has not been screened g using ultrasound during the third trimester of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no macrosomy | – | Other: Data recordpregnant women whose child is not macrosomal |
| screened macrosomy | – | Other: Data recordpregnant women whose child is macrosomal and have been screened g using ultrasound during the third trimester of pregnancy |
| no screened macrosomy | – | Other: Data recordpregnant women whose child is macrosomal and havenot been screened g using ultrasound during the third trimester of pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (3 listed)
- Women pregnant Women followed in the gynaecology and obstetrics department of the CHU of Reims, the CHG of Charleville Mézières or the CHG of Chalons en Champagne.
- Women for which the delivery is planned in the gynaecology and obstetrics department of the Reims University Hospital, the Charleville Mézières General Hospital or the Chalons en Champagne General Hospital.
- Non-inclusion criteria Women without ultrasound dating scan in the first trimester. Women having a contraindication to labour or vaginal delivery Women with a scarred uterus Women having a history of shoulder dystocia or obstetric trauma Women having a history of urinary or fecal incontinence Women having a history of bad birth experience with high psychological impact Women with maternal pathologies (excluding gestational diabetes) Women whose fetus is breech Women with twin pregnancy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Data recordData record | Other | no macrosomy, no screened macrosomy, screened macrosomy |
Primary outcome
Foetal macrosomia
Time frame: Baseline
estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
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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.
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 Pregnancy, run by CHU de Reims 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 3 inclusion and 0 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 23 Jun 2020. 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 Uzma ISHAQUE (03 10 73 62 88 ext. 0033, uishaque@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foetal macrosomia (time frame: Baseline). 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 23 Jun 2020.