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Prediction of Uterine Atony After Vaginal Delivery by Elastography

Prediction of Uterine Atony After Vaginal Delivery by Shear Wave Elastography: a Feasibility Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04267783
Enrollment
30
Registered
2020-02-13
Start date
2019-05-01
Completion date
2020-05-30
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhage, uterine atony, shear wave, elastography

Brief 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.

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 .

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Stiffness of the myometriumThird labor stage to 30 minutes post placenta deliveryDifference in median myometrial shear wave velocity between each time point: after fetal delivery, after placental delivery and 30 minutes after placental delivery.

Secondary

MeasureTime frameDescription
Blood lossTwo hours following the childbirthMeasurement of total blood loss

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026