Birth WeightMACROMODANCT06198881
Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study
An observational study of Birth Weight and Macrosomia, Fetal, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
The rising prevalence fof fetal macrosomia represents a significant challenge in obstetrics, affecting both maternal and neonatal outcomes. Such challenges include complications like perineal tears and postpartum hemorrhage. Read more about this study
- Who is it for?
- Ages 12 to 50 years, women only
- Conditions the study is for
- Birth Weight, Macrosomia, Fetal
- Type of treatment
- Pill or oral medicine
- How many people
- 4,500 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Oct 2023to 1 Jan 2024
- 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 12 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The selected patients are thoses who gave birth at term (>37 weeks) of a macrosome fetus (>4000g) in one of the maternity wards of the civil hospices of Lyon (Hospital de la Croix Rousse, Hopital Femme Mere Enfant or Hopital Lyon Sud). Patients are subsequently categorized based on whether their labor was induced or not. The characteristics of the pregnancy, the route of delivery and the fetal outcome are then collected in the computerized medical records and analyzed.
Who may be able to join
- Full-term deliveries (≥ 37 weeks of gestation)
- Singleton
- Birth weight > 4000g
- Complete medical records available for analysis
Who cannot join
- Delivery < 37 weeks
- Uterus > bi-scarred
- Presentation of the headquarters
- Maternal or fetal pathology modifying the route/time of delivery (pre-eclampsia, fetal heart rate abnormalities, cholestasis, chorioamnionitis, metrorrhagia, covering placenta, etc.)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Femme-Mère-Enfant
Bron, 69500
Croix Rousse Hospital
Lyon, 69004
Hôpital Lyon Sud
Pierre-Bénite, 69495
About this study
The rising prevalence fof fetal macrosomia represents a significant challenge in obstetrics, affecting both maternal and neonatal outcomes. Such challenges include complications like perineal tears and postpartum hemorrhage. Concurrently, the frequency of labor induction practices on the rise, yet the implications for neonatal weight are inadequately understood. To address this gap, our study aims to evaluate the association between labor induction and neontal birth weight through a population-based cohort study. The findings have the potential to inform more accurate clinical guidelines, thereby enhancing the quality of maternity care.
- Conditions
- Birth Weight, Macrosomia, Fetal
- Keywords
- macrosomia, labor induction, perineal tears, hemorrhage, full-term deliveries, singleton
- Medical subject headings
- Birth Weight, Fetal Macrosomia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| induction of labor | Patient having been induced by cervical ripening (prostin gel (2mg/24h), intravaginal prostaglandin (10mg/24h), balloon (<12h exposure time) or oral misoprostole (50µg/4h until induction of labor) or induction of contractions by oxytocin (gradual increase in dose) for suspected ultrasound macrosomia (according to the criteria of the DAME study) | |
| natural labor | Patient presenting with spontaneous labor after 37 weeks of gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of vaginal deliveries among the population studied
Number of vaginal deliveries among the population studied
Measured: during Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Oct 2023
- Primary completion1 Nov 2023
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth WeightStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198881
- Sponsor's protocol ID
- 23-5317
- Acronym
- MACROMODA
- Status last verified
- Dec 2023
- First submitted
- 27 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mazard A, Desseauve D, Boulvain M, Atallah A, Massoud M, Gaucher L, de la Fourniere B. Mode of delivery for confirmed macrosomia: a real-life multicentric observational study. BMC Pregnancy Childbirth. 2026 Apr 27;26(1):640. doi: 10.1186/s12884-026-09090-5.
PubMed 42045843
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study
- ClinicalTrials.gov ID
- NCT06198881
- Acronym / sponsor ID
- MACROMODA / 23-5317
- Conditions
- Birth Weight, Macrosomia, Fetal
- Keywords
- macrosomia, labor induction, perineal tears, hemorrhage, full-term deliveries, singleton
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
The rising prevalence fof fetal macrosomia represents a significant challenge in obstetrics, affecting both maternal and neonatal outcomes. Such challenges include complications like perineal tears and postpartum hemorrhage. Concurrently, the frequency of labor induction practices on the rise, yet the implications for neonatal weight are inadequately understood. To address this gap, our study aims to evaluate the association between labor induction and neontal birth weight through a population-based cohort study. The findings have the potential to inform more accurate clinical guidelines, thereby enhancing the quality of maternity care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| induction of labor | – | –Patient having been induced by cervical ripening (prostin gel (2mg/24h), intravaginal prostaglandin (10mg/24h), balloon (<12h exposure time) or oral misoprostole (50µg/4h until induction of labor) or induction of contractions by oxytocin (gradual increase in dose) for suspected ultrasound macrosomia (according to the criteria of the DAME study) |
| natural labor | – | –Patient presenting with spontaneous labor after 37 weeks of gestation. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The selected patients are thoses who gave birth at term (>37 weeks) of a macrosome fetus (>4000g) in one of the maternity wards of the civil hospices of Lyon (Hospital de la Croix Rousse, Hopital Femme Mere Enfant or Hopital Lyon Sud). Patients are subsequently categorized based on whether their labor was induced or not. The characteristics of the pregnancy, the route of delivery and the fetal outcome are then collected in the computerized medical records and analyzed.
Key inclusion criteria (4 listed)
- Full-term deliveries (≥ 37 weeks of gestation)
- Singleton
- Birth weight > 4000g
- Complete medical records available for analysis
Key exclusion criteria (4 listed)
- Delivery < 37 weeks
- Uterus > bi-scarred
- Presentation of the headquarters
- Maternal or fetal pathology modifying the route/time of delivery (pre-eclampsia, fetal heart rate abnormalities, cholestasis, chorioamnionitis, metrorrhagia, covering placenta, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of vaginal deliveries among the population studied
Time frame: during Delivery
Number of vaginal deliveries among the population studied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 42045843Mazard A, Desseauve D, Boulvain M, Atallah A, Massoud M, Gaucher L, de la Fourniere B. Mode of delivery for confirmed macrosomia: a real-life multicentric observational study. BMC Pregnancy Childbirth. 2026 Apr 27;26(1):640. doi: 10.1186/s12884-026-09090-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Weight and Macrosomia, Fetal, run by Hospices Civils de Lyon at 3 sites 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 4 inclusion and 4 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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 vaginal deliveries among the population studied (time frame: during Delivery). 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 NCT06198881, which also lists 1 linked publication.
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 10 Jan 2024.