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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction of labor vs waiting | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of neonatal traumatism risk | 52 months |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of maternal morbidity and caesarean | 52 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick ROZENBERG, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Poissy st Germain | Poissy | 78303 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36884238 | Derived | Boulvain M, Thornton JG. Induction of labour at or near term for suspected fetal macrosomia. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD000938. doi: 10.1002/14651858.CD000938.pub3. | |
| 25863654 | Derived | 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. |
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| ID | Term |
|---|---|
| D005320 | Fetal Macrosomia |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D005315 | Fetal Diseases |
| D011254 | Pregnancy in Diabetics |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001724 | Birth Weight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |