CHI Poissy st Germain
Poissy, 78303, France
NCT Number: NCT00190320
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.
Looking for future studies?
Notify Me18 year–48 year
Female
Interventional
Phase 4
Poissy, 78303, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 52 months
Time frame: 52 months
Assistance Publique - Hôpitaux de Paris
Other
Induction of Labor or Waiting for Suspicion Fetal Macrosomia (DAME)
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.
Published trials that share one or more normalized conditions with this study.
NCT02523222
Birth Weight, Body Weight
Houston, Texas, United States
View Trial DetailsNCT02713568
Birth Weight, Body Weight
Brussels, Belgium
View Trial DetailsNCT00826904
Birth Weight, Body Weight
Aurora, Colorado, United States
View Trial DetailsNCT03002246
Birth Weight, Body Weight
View Trial Details