Ultrasound Measure of the Thickness of the Lower Segment in Women Having a History of Caesarian

Study Overview
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Brief Summary
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The rate of caesarians dramatically increased for 15 years. The main indication of caesarian became the iterative caesarian of principle because of a history of caesarian. Any attempt of reduction of the rate of caesarians should thus focus on the indications of iterative principal caesarean. Nevertheless, the main reason usually evoked to justify a reduction of the attempts of low way after caesarian is the concern generated by the risk of uterine break during the trial of labor. Yet, there is no reliable method to predict this risk of uterine break. A way of interesting research consists in estimating the potential profits of the echography of the scar lower segment. Indeed, the echography can be useful to determine the specific risk of uterine break of a patient by measuring the thickness of the lower segment of the womb. The strong negative predictive value of the echography of the lower segment on the risk of uterine break should encourage the women encircled to accept a trial of labor. That is why, this examination associated with a rule of decision could help to decrease the rate of iterative elective caesarians and especially to decrease the mortality and the foetal and maternal morbidity connected to the trial of labor among the patients having a history of caesarian.

Detailed Description
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Lower Uterine Segment Trial (LUSTrial) Evaluation of the efficiency of the ultrasound measure of the thickness of the lower segment associated with a rule of decision to reduce the foetal and maternal morbidity and mortality in the coverage of the deliveries of the women having a history of caesarian: a pragmatic randomized trial Aim Evaluation of the efficiency of the ultrasound measure of the thickness of the lower segment associated with a rule of decision to reduce the foetal and maternal morbidity and mortality in the coverage of the deliveries of the women having a history of caesarian Methodology Randomized trial, multicentric, open, in two parallel arms. Evaluated treatments: Between 36+0 and 38+6 weeks of amenorrhea, the patients will be invited to participate in the study. After agreement, the patients respecting the criteria of inclusion and not inclusion will be randomized in two groups: GROUP A (experimental group) : The ultra sound measure of the thickness of the lower segment will be realized in a way standardized by expert sonographers. The patient will be informed that in case of measure: superior at the threshold of 3.5 mm, her will be considered  a low risk  by complications and will be encouraged to try a event of the work subordinate or equal at the threshold of 3.5 mm, her will be considered  at risk  by complications and will be encouraged to give birth by iterative elective caesarian. GROUP B (control group) : The ultra sound measure of the lower segment will not be realized. The mode of delivery will be decided according to the current clinical practice.

Official Title
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Evaluation of the Efficiency of the Ultrasound Measure of the Thickness of the Lower Segment Associated With a Rule of Decision to Reduce the Foetal and Maternal Morbidity and Mortality in the Care of the Deliveries of the Women Having a History of Caesarian: a Pragmatic Randomized Trial : Lustrial

Conditions
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Lower Uterine Segment, Labor

Intervention / Treatment
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* Other: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years unique pregnancy gestational age between 36 SA and 38SA +6 days cephalic presentation lower uterine segment section's history sign consent Exclusion Criteria: age < 18 years history of longitudinal incision's caesarean iterative caesarean indication multiple pregnancy placenta praevia patient refuse trial of labor absent consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower Uterine Segment Ultrasound<br>Measure of Uterine Segment by Ultrasound | Other: Ultrasound<br>* Measure of Uterine Segment by Ultrasound<br>|
| No Intervention: control<br>no measure of Uterine Segment Ultrasound | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite criterion including maternal and neonatal parameters | rupture uterine, uterine dehiscence, hysterectomy, deep venous thromboembolic complications, transfusion, endometritis, maternal mortality, foetal mortality antepartum, intrapartum foetal mortality, ischemic hypoxic encephalopathy, neonatal mortality | at 3 days post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine rupture |  | at 3 days post partum | 
| Uterine dehiscence | Maternal morbidity | at 3 days post partum | 
| Antepartum and intrapartum mortality | Foetal mortality | 3 days post partum | 
| Hypoxic-ischemic encephalopathy | New born morbidity | at 3 days post partum | 
| Thromboembolic complications | Maternal morbidity | at 3 days post partum | 
| Hysterectomy | Maternal morbidity | at 3 days post partum | 
| Transfusion | Maternal morbidity | at 3 days post partum | 
| Endometritis | Maternal morbidity | at 3 days post partum | 
| Rate of elective caesarean sections and of caesarean sections during labor |  | at 1 day post partum | 
| Perineal tears of the 3rd and 4th degree |  | at 1 day post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarean,, trial of labor,, ultrasound