Prediction of Uterine Atony After Vaginal Delivery by Elastography

NCT04267783 | Completed

• 1 other identifier: 2018-02267
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhage; uterine atony; shear wave; elastography

Outcome Measures

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.

  Third labor stage to 30 minutes post placenta delivery

Secondary Outcomes (1)

• Blood loss

  Two hours following the childbirth

Interventions

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 .

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

University Hospital of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: May 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

CH (1)