Fetal MacrosomiaPhase 4NCT00190320
DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia
A Phase 4 study testing Induction of labor vs waiting in people with Fetal Macrosomia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Aim of the study :The major aim is to evaluate the effectiveness of the induction of labor in case of fetal macrosomia on the reduction of neonatal traumatism risk. The secondary aims are to evaluate maternal morbidity and the risk of Caesarean in case of induction of labor, compared to a spontaneous labor. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Fetal Macrosomia
- What is being tested?
- Induction of labor vs waiting
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2005to Feb 2009
- Phase
- Phase 4
- 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 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Agreed women Sonographic estimation of begin of pregnancy <20GW Single pregnancy in cephalic presentation Macrosomic fetus :
- clinical estimation : 36GW : ≥3350g or 34cm 37GW : ≥3550gor34cm 38GW : ≥3750g or 35cm
- sonographic estimation : 36GW : ≥ 3500g 37GW : ≥ 3700g 38GW : ≥ 3900g
Who cannot join
- Typical diabetes I or typifies II or diabetes gestational treated by insulin.
- Antecedents of tear of the anal sphincter or severe urinary or faecal presence of an incontinence.
- Antecedent of dystocia of the shoulders or neonatal traumatism.
- Antecedents of caesarian or uterine scar.
- contraindication in the release of the work or in the childbirth by low way.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction of Labor or Waiting for Suspicion Fetal Macrosomia (DAME)
Aim of the study :The major aim is to evaluate the effectiveness of the induction of labor in case of fetal macrosomia on the reduction of neonatal traumatism risk. The secondary aims are to evaluate maternal morbidity and the risk of Caesarean in case of induction of labor, compared to a spontaneous labor.
Read the detailed description
A clinical trial multicentric randomized controlled will be organized. A total of 1000 women will be recruited between 36 and 38 weeks of amenorrhoea (GW) if the pregnancy is single, in cephalic presentation and the fetus is estimated macrosomic for the gestational age (> 90e percentile clinically and >95° percentile sonographically).All agreeing patients will be randomized in one of the two following groups: - 1. Induction of labor between 37+0 and 38+6 GW and within 3 day after the randomization. - 2. Expectancy until the spontaneous beginning of labor or up to 41 GW.The measurement of principal exit is the neonatal traumatism (criterion composite associating: dystocia of the shoulders, fractures osseous, paralysis/paresis of the plexus brachial or intracerebral haemorrhage).The secondary criteria are neonatal asphyxiation (arterial pH < 7.10 or Apgar < 7 to 5 minutes), the maternal traumatism (tear of 3rd or 4th degree) and the Caesarean. The long-term after-effects for the mother and her child will be also evaluated
- Conditions
- Fetal Macrosomia
- Being tested
- Induction of labor vs waiting
- Keywords
- Fetal macrosomia, Neonatal traumatism, Maternal morbidity
- Medical subject headings
- Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of labor vs waitingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of neonatal traumatism risk
Measured: 52 months
Secondary outcomes (1)
reduction of maternal morbidity and caesarean
Measured: 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal MacrosomiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Patrick ROZENBERG, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190320
- Sponsor's protocol ID
- P030417
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boulvain M, Thornton JG. Induction of labour at or near term for suspected fetal macrosomia. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD000938. doi: 10.1002/14651858.CD000938.pub3.
PubMed 36884238Boulvain M, Senat MV, Perrotin F, Winer N, Beucher G, Subtil D, Bretelle F, Azria E, Hejaiej D, Vendittelli F, Capelle M, Langer B, Matis R, Connan L, Gillard P, Kirkpatrick C, Ceysens G, Faron G, Irion O, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial. Lancet. 2015 Jun 27;385(9987):2600-5. doi: 10.1016/S0140-6736(14)61904-8. Epub 2015 Apr 8.
PubMed 25863654
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labor or Waiting for Suspicion Fetal Macrosomia (DAME)
- ClinicalTrials.gov ID
- NCT00190320
- Acronym / sponsor ID
- P030417
- Conditions
- Fetal Macrosomia
- Keywords
- Fetal macrosomia, Neonatal traumatism, Maternal morbidity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Sep 2005 (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.
Aim of the study :The major aim is to evaluate the effectiveness of the induction of labor in case of fetal macrosomia on the reduction of neonatal traumatism risk. The secondary aims are to evaluate maternal morbidity and the risk of Caesarean in case of induction of labor, compared to a spontaneous labor.
Detailed description
A clinical trial multicentric randomized controlled will be organized. A total of 1000 women will be recruited between 36 and 38 weeks of amenorrhoea (GW) if the pregnancy is single, in cephalic presentation and the fetus is estimated macrosomic for the gestational age (> 90e percentile clinically and >95° percentile sonographically).All agreeing patients will be randomized in one of the two following groups: - 1. Induction of labor between 37+0 and 38+6 GW and within 3 day after the randomization. - 2. Expectancy until the spontaneous beginning of labor or up to 41 GW.The measurement of principal exit is the neonatal traumatism (criterion composite associating: dystocia of the shoulders, fractures osseous, paralysis/paresis of the plexus brachial or intracerebral haemorrhage).The secondary criteria are neonatal asphyxiation (arterial pH < 7.10 or Apgar < 7 to 5 minutes), the maternal traumatism (tear of 3rd or 4th degree) and the Caesarean. The long-term after-effects for the mother and her child will be also evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Agreed women Sonographic estimation of begin of pregnancy <20GW Single pregnancy in cephalic presentation Macrosomic fetus :
- clinical estimation : 36GW : ≥3350g or 34cm 37GW : ≥3550gor34cm 38GW : ≥3750g or 35cm
- sonographic estimation : 36GW : ≥ 3500g 37GW : ≥ 3700g 38GW : ≥ 3900g
Key exclusion criteria (5 listed)
- Typical diabetes I or typifies II or diabetes gestational treated by insulin.
- Antecedents of tear of the anal sphincter or severe urinary or faecal presence of an incontinence.
- Antecedent of dystocia of the shoulders or neonatal traumatism.
- Antecedents of caesarian or uterine scar.
- contraindication in the release of the work or in the childbirth by low way.
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 labor vs waiting | Procedure or surgery | – |
Primary outcome
reduction of neonatal traumatism risk
Time frame: 52 months
1 secondary outcome
reduction of maternal morbidity and caesarean
Time frame: 52 months
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 17 Feb 2011.
- Derived from this study: PubMed 36884238Boulvain M, Thornton JG. Induction of labour at or near term for suspected fetal macrosomia. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD000938. doi: 10.1002/14651858.CD000938.pub3.
- Derived from this study: PubMed 25863654Boulvain M, Senat MV, Perrotin F, Winer N, Beucher G, Subtil D, Bretelle F, Azria E, Hejaiej D, Vendittelli F, Capelle M, Langer B, Matis R, Connan L, Gillard P, Kirkpatrick C, Ceysens G, Faron G, Irion O, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial. Lancet. 2015 Jun 27;385(9987):2600-5. doi: 10.1016/S0140-6736(14)61904-8. Epub 2015 Apr 8.
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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.
Patrick ROZENBERG, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Induction of labor vs waiting in people with Fetal Macrosomia, run by Assistance Publique - Hôpitaux de Paris 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 5 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 17 Feb 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
reduction of neonatal traumatism risk (time frame: 52 months). 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 NCT00190320, which also lists 2 linked publications.
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 17 Feb 2011.