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

NCT ID: NCT01916044

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2955 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-11
• Study Completion Date: 2019-01-22

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.

Conditions

Lower Uterine Segment; Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lower Uterine Segment Ultrasound

Measure of Uterine Segment by Ultrasound

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: OTHER

Measure of Uterine Segment by Ultrasound

control

no measure of Uterine Segment Ultrasound

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ultrasound

Measure of Uterine Segment by Ultrasound

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Rozenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHI Poissy

Locations

CHI Poissy Saint Germain

Poissy, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 34384777 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29625873 (View on PubMed)

Other Identifiers

P111103

Identifier Type: -

Identifier Source: org_study_id