Skip to main content
OpenTrials
Completed

NCT Number: NCT01916044

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Uterine Segment Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHI Poissy Saint Germain

Poissy, France

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound

Other

Measure of Uterine Segment by Ultrasound

Primary outcomes

  1. Composite criterion including maternal and neonatal parameters

    Time frame: at 3 days post partum

    rupture uterine, uterine dehiscence, hysterectomy, deep venous thromboembolic complications, transfusion, endometritis, maternal mortality, foetal mortality antepartum, intrapartum foetal mortality, ischemic hypoxic encephalopathy, neonatal mortality

Secondary outcomes

  1. Uterine rupture

    Time frame: at 3 days post partum

  2. Uterine dehiscence

    Time frame: at 3 days post partum

    Maternal morbidity

  3. Antepartum and intrapartum mortality

    Time frame: 3 days post partum

    Foetal mortality

  4. Hypoxic-ischemic encephalopathy

    Time frame: at 3 days post partum

    New born morbidity

  5. Thromboembolic complications

    Time frame: at 3 days post partum

    Maternal morbidity

  6. Hysterectomy

    Time frame: at 3 days post partum

    Maternal morbidity

  7. Transfusion

    Time frame: at 3 days post partum

    Maternal morbidity

  8. Endometritis

    Time frame: at 3 days post partum

    Maternal morbidity

  9. Rate of elective caesarean sections and of caesarean sections during labor

    Time frame: at 1 day post partum

  10. Perineal tears of the 3rd and 4th degree

    Time frame: at 1 day post partum

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Aug 5, 2013
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.