Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01916044
Enrollment
2955
Registered
2013-08-05
Start date
2013-07-11
Completion date
2019-01-22
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Lower Uterine Segment

Keywords

caesarean,, trial of labor,, ultrasound

Brief summary

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

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.

Interventions

OTHERUltrasound

Measure of Uterine Segment by Ultrasound

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite criterion including maternal and neonatal parametersat 3 days post partumrupture uterine, uterine dehiscence, hysterectomy, deep venous thromboembolic complications, transfusion, endometritis, maternal mortality, foetal mortality antepartum, intrapartum foetal mortality, ischemic hypoxic encephalopathy, neonatal mortality

Secondary

MeasureTime frameDescription
Uterine dehiscenceat 3 days post partumMaternal morbidity
Antepartum and intrapartum mortality3 days post partumFoetal mortality
Hypoxic-ischemic encephalopathyat 3 days post partumNew born morbidity
Thromboembolic complicationsat 3 days post partumMaternal morbidity
Uterine ruptureat 3 days post partum
Transfusionat 3 days post partumMaternal morbidity
Endometritisat 3 days post partumMaternal morbidity
Rate of elective caesarean sections and of caesarean sections during laborat 1 day post partum
Perineal tears of the 3rd and 4th degreeat 1 day post partum
Hysterectomyat 3 days post partumMaternal morbidity

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026