Prediction of Uterine Atony After Vaginal Delivery by Elastography

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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Key information

Conditions

Postpartum Hemorrhage Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage Uterine Inertia

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shear Wave Elastography

Diagnostic 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 .

Primary outcomes

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.

Secondary outcomes

Blood loss

Time frame: Two hours following the childbirth

Measurement of total blood loss

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Feb 13, 2020
Registry last updated: Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed