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

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.

Study Overview

• Status: Completed
• Conditions: Labor; Lower Uterine Segment
• Intervention / Treatment: Other: Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 2955
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poissy, France
    • CHI Poissy Saint Germain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower Uterine Segment Ultrasound; Measure of Uterine Segment by Ultrasound	Other: Ultrasound; Measure of Uterine Segment by Ultrasound
No Intervention: control; no measure of Uterine Segment Ultrasound

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Unité de Recherche Clinique Necker Cochin, France
• Investigators: Principal Investigator: Patrick Rozenberg, MD, PhD, Chi Poissy

Publications and helpful links

General Publications

• Rozenberg P, Deruelle P, Senat MV, Desbriere R, Winer N, Simon E, Ville Y, Kayem G, Boutron I; Groupe de recherche en obstetrique et gynecologie. [Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial]. Gynecol Obstet Fertil Senol. 2018 Apr;46(4):427-432. doi: 10.1016/j.gofs.2018.03.005. Epub 2018 Apr 4. French.
• Rozenberg P, Senat MV, Deruelle P, Winer N, Simon E, Ville Y, Kayem G, Porcher R, Perrodeau E, Desbriere R, Boutron I; Groupe de Recherche en Obstetrique et Gynecologie. Evaluation of the usefulness of ultrasound measurement of the lower uterine segment before delivery of women with a prior cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2022 Feb;226(2):253.e1-253.e9. doi: 10.1016/j.ajog.2021.08.005. Epub 2021 Aug 9.

Study record dates

Study Major Dates

• Study Start: July 11, 2013
• Primary Completion (Actual): May 11, 2018
• Study Completion (Actual): January 22, 2019

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimated): August 5, 2013

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; caesarean,; trial of labor,
• Additional Relevant MeSH Terms: Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID Numbers: P111103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO