Clinical Trial: DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: reduction of neonatal traumatism risk [ Time Frame: 52 months ]

Original Primary Outcome: reduction of neonatal traumatism risk

Current Secondary Outcome: reduction of maternal morbidity and caesarean [ Time Frame: 52 months ]

Original Secondary Outcome: reduction of maternal morbidity and caesarean

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 13, 2005
Date Started: February 2005
Date Completion:
Last Updated: February 16, 2011
Last Verified: March 2007