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Completed

NCT Number: NCT00190320

DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Induction of labor vs waiting

Procedure

Primary outcomes

  1. reduction of neonatal traumatism risk

    Time frame: 52 months

Secondary outcomes

  1. reduction of maternal morbidity and caesarean

    Time frame: 52 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Induction of Labor or Waiting for Suspicion Fetal Macrosomia (DAME)

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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