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CompletedNCT04267783Updated Sep 2, 2020

Prediction of Uterine Atony After Vaginal Delivery by Elastography

An observational study in Postpartum Hemorrhage, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by Centre Hospitalier Universitaire Vaudois · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 35 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Postpartum Hemorrhage

Keywords

  • postpartum hemorrhage
  • uterine atony
  • shear wave
  • elastography
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In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 30 is below the median of 150 across 91 observational studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testShear wave elastography

    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 .

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Third labor stage to 30 minutes post placenta delivery

Secondary outcomes

  1. Blood loss

    Measurement of total blood loss

    Time frame: Two hours following the childbirth

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Study locations

1 site
  • University Hospital of Lausanne
    Lausanne, Vaud 1011, Switzerland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04267783
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Responsible party
DAVID DESSEAUVE (Principal investigator, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Feb 13, 2020
Start date
May 1, 2019
Primary completion
Apr 30, 2020
Completion
May 30, 2020
Last update
Sep 2, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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