MacrosomiaNCT03355040
Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.
An observational study of Macrosomia and Induction of Labour, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced. This new protocole was introduced in Montpellier University Hospital delivery room. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Macrosomia, Induction of Labour, Non-insulin-dependent Diabetes
- What is being tested?
- induction of labour
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2016to 1 Jan 2019
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant patients non diabetic or diabetic without insulin-treatment with large for date fœtus.
Who may be able to join
- Age >18 years old Single pregnancy Cephalic presentation no contraindications to planned vaginal delivery no fœtal pathology
- Large-for-date foetus (estimated weight > 95%) :
- Clinically suspeted or estilated weight >90% at the 3 trimester ultrasound
- Estimated fœtal weight :
- > 3500g at 36 GA > 3700g at 37 GA > 3900g at 38 GA
Who cannot join
- Age <18 yeaurs old contraindications to vaginal delivery insulin-trated diabetics or imbalance diabetics. neonatal trauma or shoulder dystocia, severe urinary or faecal incontinence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.
A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced.
This new protocole was introduced in Montpellier University Hospital delivery room.
The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our results with the DAME results.
Read the detailed description
Currently, large for date fœtus need an induction of labour just if the mother is an insulin diabetic.
The DAME's protocol included the large for date feotus witch have a estimate weight >3500g at 36 GA, >3700g at 37 GA, >3900g at 38 GA.
- Being tested
- induction of labour
- Keywords
- shoulder dystocia, maternal and neonatal morbidity
- Medical subject headings
- Diabetes Mellitus, Type 2, Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction of labourOther
induction of labour
What is being measured
The primary outcome is the main question the study is designed to answer.
number of shoulder dystocia
number of shoulder dystocia
Measured: 1 day (after delivery)
number of Clavicle fracture
number of Clavicle fracture
Measured: 1 day (after delivery)
number of Brachial plexus injury
number of Brachial plexus injury
Measured: 1 day (after delivery)
number of Intracranial heamorrhage
number of Intracranial heamorrhage
Measured: 1 day (after delivery)
number of Neonatal death
number of Neonatal death
Measured: 1 day (after delivery)
Secondary outcomes (8)
Number of Cord blood pH< 7,10 for the newborn
Number of Cord blood pH< 7,10 for the newborn
Measured: 1 day (after delivery)
Number of apgar < 7 at 5 min for the newborn
Number of apgar < 7 at 5 min for the newborn
Measured: 1 day (after delivery)
Number of admission to neonatal intensive care unit for the newborn
Number of admission to neonatal intensive care unit for the newborn
Measured: 1 day (after delivery)
Number of highest bilirubin concentration for the newborn
Number of highest bilirubin concentration for the newborn
Measured: 1 day (after delivery)
Number of Caesarean for the patient
Number of Caesarean for the patient
Measured: 1 day (after delivery)
Number of Forceps or vacuum for the patient
Number of Forceps or vacuum for the patient
Measured: 1 day (after delivery)
Number of Haemorrage and blood transfusion for the patient
Number of Haemorrage and blood transfusion for the patient
Measured: 1 day (after delivery)
Number of Anal sphincter tear for the patient
Number of Anal sphincter tear for the patient
Measured: 1 day (after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Apr 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MacrosomiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- florent FUCHS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355040
- Sponsor's protocol ID
- RECHMPL17_0261
- Status last verified
- Apr 2019
- First submitted
- 12 Oct 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.
- ClinicalTrials.gov ID
- NCT03355040
- Acronym / sponsor ID
- RECHMPL17_0261
- Keywords
- shoulder dystocia, maternal and neonatal morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 28 Nov 2017 (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.
A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced.
This new protocole was introduced in Montpellier University Hospital delivery room.
The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our results with the DAME results.
Detailed description
Currently, large for date fœtus need an induction of labour just if the mother is an insulin diabetic.
The DAME's protocol included the large for date feotus witch have a estimate weight >3500g at 36 GA, >3700g at 37 GA, >3900g at 38 GA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant patients non diabetic or diabetic without insulin-treatment with large for date fœtus.
Key inclusion criteria (5 listed)
- Age >18 years old Single pregnancy Cephalic presentation no contraindications to planned vaginal delivery no fœtal pathology
- Clinically suspeted or estilated weight >90% at the 3 trimester ultrasound
- Estimated fœtal weight :
- > 3500g at 36 GA > 3700g at 37 GA > 3900g at 38 GA
Key exclusion criteria (1 listed)
- Age <18 yeaurs old contraindications to vaginal delivery insulin-trated diabetics or imbalance diabetics. neonatal trauma or shoulder dystocia, severe urinary or faecal incontinence.
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 |
|---|---|---|
| induction of labourinduction of labour | Other | – |
Primary outcome
number of shoulder dystocia
Time frame: 1 day (after delivery)
number of shoulder dystocia
number of Clavicle fracture
Time frame: 1 day (after delivery)
number of Clavicle fracture
number of Brachial plexus injury
Time frame: 1 day (after delivery)
number of Brachial plexus injury
number of Intracranial heamorrhage
Time frame: 1 day (after delivery)
number of Intracranial heamorrhage
number of Neonatal death
Time frame: 1 day (after delivery)
number of Neonatal death
8 secondary outcomes
Number of Cord blood pH< 7,10 for the newborn
Time frame: 1 day (after delivery)
Number of apgar < 7 at 5 min for the newborn
Time frame: 1 day (after delivery)
Number of admission to neonatal intensive care unit for the newborn
Time frame: 1 day (after delivery)
Number of highest bilirubin concentration for the newborn
Time frame: 1 day (after delivery)
Number of Caesarean for the patient
Time frame: 1 day (after delivery)
Number of Forceps or vacuum for the patient
Time frame: 1 day (after delivery)
Number of Haemorrage and blood transfusion for the patient
Time frame: 1 day (after delivery)
Number of Anal sphincter tear for the patient
Time frame: 1 day (after delivery)
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 18 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
florent FUCHS principal investigator
University Hospital, Montpellier
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 Macrosomia and Induction of Labour, run by University Hospital, Montpellier 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 5 inclusion and 1 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 18 Apr 2019. 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 shoulder dystocia (time frame: 1 day (after delivery)). The study lists 5 primary outcomes in all. 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 18 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.