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DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia

Primary Purpose

Fetal Macrosomia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Induction of labor vs waiting
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Macrosomia focused on measuring Fetal macrosomia, Neonatal traumatism, Maternal morbidity

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • CHI Poissy st Germain

Outcomes

Primary Outcome Measures

reduction of neonatal traumatism risk

Secondary Outcome Measures

reduction of maternal morbidity and caesarean

Full Information

First Posted
September 13, 2005
Last Updated
February 16, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00190320
Brief Title
DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia
Official Title
Induction of Labor or Waiting for Suspicion Fetal Macrosomia (DAME)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Macrosomia
Keywords
Fetal macrosomia, Neonatal traumatism, Maternal morbidity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Induction of labor vs waiting
Primary Outcome Measure Information:
Title
reduction of neonatal traumatism risk
Time Frame
52 months
Secondary Outcome Measure Information:
Title
reduction of maternal morbidity and caesarean
Time Frame
52 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick ROZENBERG, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHI Poissy st Germain
City
Poissy
ZIP/Postal Code
78303
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25863654
Citation
Boulvain 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.
Results Reference
derived

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DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia

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