Text Size

DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190320
First received: September 13, 2005
Last updated: February 16, 2011
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Fetal Macrosomia
 Procedure: Induction of labor vs waiting
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction of Labor or Waiting for Suspicion Fetal Macrosomia (DAME)

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • reduction of neonatal traumatism risk [ Time Frame: 52 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • reduction of maternal morbidity and caesarean [ Time Frame: 52 months ] [ Designated as safety issue: Yes ]

Enrollment: 1000
Study Start Date: February 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190320

Locations
France
CHI Poissy st Germain
Poissy, France, 78303
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Patrick ROZENBERG, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Christophe AUCAN, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190320     History of Changes
Other Study ID Numbers: P030417
Study First Received: September 13, 2005
Last Updated: February 16, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fetal macrosomia
Neonatal traumatism
Maternal morbidity

Additional relevant MeSH terms:
Fetal Macrosomia
Diabetes, Gestational
Pregnancy Complications
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013