DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia

NCT00190320 | Completed Phase 4 DMC

• 1 other identifier: P030417
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Macrosomia

Keywords

Fetal macrosomia; Neonatal traumatism; Maternal morbidity

Outcome Measures

Primary Outcomes (1)

• reduction of neonatal traumatism risk

  52 months

Secondary Outcomes (1)

• reduction of maternal morbidity and caesarean

  52 months

Interventions

Induction of labor vs waiting PROCEDURE

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHI Poissy st Germain

Poissy, 78303, France

Location

Related Publications (2)

• 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.

  PMID: 36884238 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.

  PMID: 25863654 DERIVED

MeSH Terms

Conditions

Fetal Macrosomia

Condition Hierarchy (Ancestors)

Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick ROZENBERG, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 17, 2011

Record last verified: 2007-03

Locations

FR (1)