DAME: Induction of Labor or Waiting for Suspicion Fetal Macrosomia
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.
Description
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
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Fetal Macrosomia
Intervention
Induction of labor vs waiting
Location
CHI Poissy st Germain
Poissy
France
78303
Status
Recruiting
Source
Assistance Publique - Hôpitaux de Paris
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00190320
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Fetal Macrosomia
A condition of fetal overgrowth leading to a large-for-gestational-age FETUS. It is defined as BIRTH WEIGHT greater than 4,000 grams or above the 90th percentile for population and sex-specific growth curves. It is commonly seen in GESTATIONAL DIABETES; PROLONGED PREGNANCY; and pregnancies complicated by pre-existing diabetes mellitus.
Labor Presentation
The position or orientation of the FETUS at near term or during OBSTETRIC LABOR, determined by its relation to the SPINE of the mother and the birth canal. The normal position is a vertical, cephalic presentation with the fetal vertex flexed on the NECK.
Appointments And Schedules
The different methods of scheduling patient visits, appointment systems, individual or group appointments, waiting times, waiting lists for hospitals, walk-in clinics, etc.
Uterine Monitoring
Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.
Labor Onset
The beginning of true OBSTETRIC LABOR which is characterized by the cyclic uterine contractions of increasing frequency, duration, and strength causing CERVICAL DILATATION to begin (LABOR STAGE, FIRST ).
Clinical Trials
Combined Agent Randomized Trial of Induction of Labor
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from...
Fetal ST Segment and T Wave Analysis in Labor
The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instr...
Misoprostol Vaginal Insert (MVI) 100, 150, 200 Mcg for Cervical Ripening and Induction of Labor
Randomized, double blind, dose ranging study to assess the efficacy and safety of up to 24 hours treatment with the MVI 100, MVI 150 and MVI 200. Oxytocin may be used after removal of the...
Exploration of the Lipid Metabolism During the Diabetic Pregnancies
Justification: Intrauterine exposure to type 1 or type 2 diabetes increase the risk of macrosomia (35 % to 50 % versus 10 % in general population) despite a good glycemic control. The con...
Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
In this research project the investigators want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.
PubMed Articles
Abstract Aims: To evaluate the efficacy of acupuncture, and sweeping of the fetal membranes, as methods for induction of labor. Methods: Four hundred and seven pregnant women with normal singleton pre...
First-Trimester Prediction of Macrosomia.
Objective: To determine if combinations of maternal characteristics and measurements of parameters used in screening for aneuploidies at 11-13 weeks provide significant prediction of macrosomia. Metho...
Prediction of successful labor induction using transvaginal sonographic cervical measurements.
PURPOSE: To predict the success of labor induction by sonographic cervical measurements, maternal/obstetrical factors, and the Bishop's score. METHODS: Between February 2008 and February 2010, 190 con...
Induction of Labor Versus Expectant Management for Pregnancies Beyond 41 Weeks.
Abstract Objective: To compare the outcome following labor induction at 41+1 weeks of gestation and after expectant management and selective induction at 42 completed weeks. Methods: A retrospective a...
Late pregnancy complications can affect risk estimates of elective induction of labor.
Objective. Multiple observational studies have emphasized the increased risk of elective induction versus spontaneous labor. We estimated the risks of elective induction before 39 weeks compared to...
