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

NCT01916044 | Completed

• 1 other identifier: P111103
• Study Type: interventional
• Target: 2,955
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Uterine Segment; Labor

Keywords

caesarean,; trial of labor,; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Uterine rupture

  at 3 days post partum

• Uterine dehiscence

  at 3 days post partum

• Antepartum and intrapartum mortality

  3 days post partum

• Hypoxic-ischemic encephalopathy

  at 3 days post partum

• Thromboembolic complications

  at 3 days post partum

Study Arms (2)

Lower Uterine Segment Ultrasound

EXPERIMENTAL

Measure of Uterine Segment by Ultrasound

Other: Ultrasound

control

NO INTERVENTION

no measure of Uterine Segment Ultrasound

Interventions

Ultrasound OTHER

Measure of Uterine Segment by Ultrasound

Lower Uterine Segment Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• unique pregnancy
• gestational age between 36 SA and 38SA +6 days
• cephalic presentation
• lower uterine segment section's history
• sign consent

You may not qualify if:

• age \< 18 years
• history of longitudinal incision's caesarean
• iterative caesarean indication
• multiple pregnancy
• placenta praevia
• patient refuse trial of labor
• absent consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

CHI Poissy Saint Germain

Poissy, France

Location

Related Publications (2)

• 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.

  PMID: 34384777 BACKGROUND

• 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.

  PMID: 29625873 DERIVED

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Patrick Rozenberg, MD, PhD

  CHI Poissy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 5, 2013
• Study Start: July 11, 2013
• Primary Completion: May 11, 2018
• Study Completion: January 22, 2019
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)