Postpartum HemorrhageNCT04267783
Prediction of Uterine Atony After Vaginal Delivery by Elastography
An observational study of Postpartum Hemorrhage, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Prospective study evaluating the feasibility of shear-wave elastography of the uterus during the third stage of labour and following placental delivery. The investigators hypothesize that the stiffness of the myometrium can be measured by using shear-wave technology. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Shear wave elastography
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2019to 30 May 2020
- Phase
- Observational
- 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 to 35 years
- Women only
- Adult
Study population: Women above 37 weeks of gestation without known risk factors for postpartum hemorrhage who have vaginal births in our centre will be eligible for this study
Who may be able to join
- singleton pregnancy
- cephalic presentation
- maternal age > 18 years old
- nulliparous
- healthy uncomplicated pregnancy
- gestational age between 37-42 weeks of gestation
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- spontaneous labour and delivery
- uncomplicated progression of labour (cervical dilatation at >1 cm/h)
- administration of less than 3 units of oxytocin during the second stage of labour
- patient having read, accepted and signed the consent form
Who cannot join
- antepartum hemorrhage in the present pregnancy
- protracted second stage of labour (more than two hours from full dilatation to delivery)
- more than 30 minutes of active pushing
- BMI > 35 kg/m2
- distance from skin to uterus > 8 cm
- age > 35 years old
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- instrumental deliveries
- bleeding disorders
- polyhydramnios
- diabetes
- pre-eclampsia
- high blood pressure
- use of anticoagulant medications
- clinical chorioamnionitis
- placental abnormality (low-lying or abruption)
- fetal macrosomia
- uterine fibroids
- uterine anomalies
- previous uterine scar
- multiple pregnancy
- placental retention
- inability to follow procedures or insufficient knowledge of project language
- inability to give consent
- refusal to participate
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Prediction of Uterine Atony After Vaginal Delivery by Shear Wave Elastography: a Feasibility Study
Prospective study evaluating the feasibility of shear-wave elastography of the uterus during the third stage of labour and following placental delivery. The investigators hypothesize that the stiffness of the myometrium can be measured by using shear-wave technology. This study involves 30 patients with a healthy pregnancy and spontaneous vaginal delivery. One co-investigator will carry out measurements at the uterine fundus, at three different time points: after fetal delivery, after placental delivery and 30 minutes after placental delivery.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Shear wave elastography
- Keywords
- postpartum hemorrhage, uterine atony, shear wave, elastography
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastographyDiagnostic test
Investigate the feasibility of use of shear-wave elastography of the uterus during the third stage of labour and following placental delivery in order to predict uterine atony .
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness of the myometrium
Difference in median myometrial shear wave velocity between each time point: after fetal delivery, after placental delivery and 30 minutes after placental delivery.
Measured: Third labor stage to 30 minutes post placenta delivery
Secondary outcomes (1)
Blood loss
Measurement of total blood loss
Measured: Two hours following the childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 May 2019
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID DESSEAUVE, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267783
- Sponsor's protocol ID
- 2018-02267
- Other IDs
- 2018
- Status last verified
- Aug 2020
- First submitted
- 11 Feb 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Uterine Atony After Vaginal Delivery by Shear Wave Elastography: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04267783
- Acronym / sponsor ID
- 2018-02267
- Conditions
- Postpartum Hemorrhage
- Keywords
- postpartum hemorrhage, uterine atony, shear wave, elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 13 Feb 2020 (actual)
- 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.
Prospective study evaluating the feasibility of shear-wave elastography of the uterus during the third stage of labour and following placental delivery. The investigators hypothesize that the stiffness of the myometrium can be measured by using shear-wave technology. This study involves 30 patients with a healthy pregnancy and spontaneous vaginal delivery. One co-investigator will carry out measurements at the uterine fundus, at three different time points: after fetal delivery, after placental delivery and 30 minutes after placental delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women above 37 weeks of gestation without known risk factors for postpartum hemorrhage who have vaginal births in our centre will be eligible for this study
Key inclusion criteria (10 listed)
- singleton pregnancy
- cephalic presentation
- maternal age > 18 years old
- nulliparous
- healthy uncomplicated pregnancy
Key exclusion criteria (24 listed)
- antepartum hemorrhage in the present pregnancy
- protracted second stage of labour (more than two hours from full dilatation to delivery)
- more than 30 minutes of active pushing
- BMI > 35 kg/m2
- distance from skin to uterus > 8 cm
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 |
|---|---|---|
| Shear wave elastographyInvestigate the feasibility of use of shear-wave elastography of the uterus during the third stage of labour and following placental delivery in order to predict uterine atony . | Diagnostic test | – |
Primary outcome
Stiffness of the myometrium
Time frame: Third labor stage to 30 minutes post placenta delivery
Difference in median myometrial shear wave velocity between each time point: after fetal delivery, after placental delivery and 30 minutes after placental delivery.
1 secondary outcome
Blood loss
Time frame: Two hours following the childbirth
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 2 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 10 inclusion and 24 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 2 Sep 2020. 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 Switzerland. 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?
Stiffness of the myometrium (time frame: Third labor stage to 30 minutes post placenta delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.