Prediction of Uterine Atony After Vaginal Delivery by Elastography

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267783
• Other study ID #: 2018-02267
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Uterine Inertia

Intervention

Diagnostic Test:
• Shear 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 .

Locations

Country	Name	City	State
Switzerland	University Hospital of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Third labor stage to 30 minutes post placenta delivery
Secondary	Blood loss	Measurement of total blood loss	Two hours following the childbirth