Lower Uterine SegmentNCT01916044
Ultrasound Measure of the Thickness of the Lower Segment in Women Having a History of Caesarian
A study testing Ultrasound in people with Lower Uterine Segment and Labor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lower Uterine Segment, Labor
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,955 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2013to 22 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- unique pregnancy
- gestational age between 36 SA and 38SA +6 days
- cephalic presentation
- lower uterine segment section's history
- sign consent
Who cannot join
- age < 18 years
- history of longitudinal incision's caesarean
- iterative caesarean indication
- multiple pregnancy
- placenta praevia
- patient refuse trial of labor
- absent consent
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Ultrasound
- Keywords
- caesarean,, trial of labor,, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Measure of Uterine Segment by Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Lower Uterine Segment Ultrasound | Experimental | Measure of Uterine Segment by Ultrasound Receives: Other: Ultrasound |
| control | No intervention | no measure of Uterine Segment Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 3 days post partum
Secondary outcomes (10)
Uterine rupture
Measured: at 3 days post partum
Uterine dehiscence
Maternal morbidity
Measured: at 3 days post partum
Antepartum and intrapartum mortality
Foetal mortality
Measured: 3 days post partum
Hypoxic-ischemic encephalopathy
New born morbidity
Measured: at 3 days post partum
Thromboembolic complications
Maternal morbidity
Measured: at 3 days post partum
Hysterectomy
Maternal morbidity
Measured: at 3 days post partum
Transfusion
Maternal morbidity
Measured: at 3 days post partum
Endometritis
Maternal morbidity
Measured: at 3 days post partum
Rate of elective caesarean sections and of caesarean sections during labor
Measured: at 1 day post partum
Perineal tears of the 3rd and 4th degree
Measured: at 1 day post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start11 Jul 2013
- Primary completion11 May 2018
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Uterine SegmentStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,955 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Patrick Rozenberg, MD, PhD, Principal investigator, CHI Poissy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916044
- Sponsor's protocol ID
- P111103
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2013
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34384777Rozenberg 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.
PubMed 29625873
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01916044
- Acronym / sponsor ID
- P111103
- Conditions
- Lower Uterine Segment, Labor
- Keywords
- caesarean,, trial of labor,, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,955 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Jul 2013
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Uterine Segment Ultrasound | Experimental | Other: UltrasoundMeasure of Uterine Segment by Ultrasound |
| control | No intervention | –no measure of Uterine Segment Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- unique pregnancy
- gestational age between 36 SA and 38SA +6 days
- cephalic presentation
- lower uterine segment section's history
Key exclusion criteria (7 listed)
- age < 18 years
- history of longitudinal incision's caesarean
- iterative caesarean indication
- multiple pregnancy
- placenta praevia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundMeasure of Uterine Segment by Ultrasound | Other | Lower Uterine Segment Ultrasound |
Primary outcome
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
10 secondary outcomes
Uterine rupture
Time frame: at 3 days post partum
Uterine dehiscence
Time frame: at 3 days post partum
Antepartum and intrapartum mortality
Time frame: 3 days post partum
Hypoxic-ischemic encephalopathy
Time frame: at 3 days post partum
Thromboembolic complications
Time frame: at 3 days post partum
Hysterectomy
Time frame: at 3 days post partum
Transfusion
Time frame: at 3 days post partum
Endometritis
Time frame: at 3 days post partum
Rate of elective caesarean sections and of caesarean sections during labor
Time frame: at 1 day post partum
Perineal tears of the 3rd and 4th degree
Time frame: at 1 day post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 34384777Rozenberg 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.
- Derived from this study: PubMed 29625873Rozenberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Rozenberg, MD, PhD principal investigator
CHI Poissy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Lower Uterine Segment and Labor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite criterion including maternal and neonatal parameters (time frame: at 3 days post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916044, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.