Prediction of Uterine Atony After Vaginal Delivery by Elastography

Completed

• Conditions: Postpartum Hemorrhage

• Registration Number: NCT04267783
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stiffness of the myometrium	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 Outcome Measures

Name	Time	Method
Blood loss	Two hours following the childbirth	Measurement of total blood loss

Trial Locations

Locations (1)

University Hospital of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland