Prediction of Uterine Atony After Vaginal Delivery by Elastography

August 31, 2020 updated by: DAVID DESSEAUVE, Centre Hospitalier Universitaire Vaudois

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • University Hospital of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • singleton pregnancy
  • cephalic presentation
  • maternal age > 18 years old
  • nulliparous
  • healthy uncomplicated pregnancy
  • gestational age between 37-42 weeks of gestation
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Third labor stage to 30 minutes post placenta delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Two hours following the childbirth
Measurement of total blood loss
Two hours following the childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-02267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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