Status:
COMPLETED
DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Fetal Macrosomia
Eligibility:
FEMALE
18-48 years
Phase:
PHASE4
Brief 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 ...
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 prese...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00190320
Start Date
February 1 2005
End Date
February 1 2009
Last Update
February 17 2011
Active Locations (1)
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1
CHI Poissy st Germain
Poissy, France, 78303