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Clinical Trials/NCT04267783
NCT04267783
Completed
Not Applicable

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

Centre Hospitalier Universitaire Vaudois1 site in 1 country30 target enrollmentStarted: May 1, 2019Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Stiffness of the myometrium

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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
  • pre-eclampsia

Outcomes

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(Two hours following the childbirth)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

DAVID DESSEAUVE

Principal investigator

Centre Hospitalier Universitaire Vaudois

Study Sites (1)

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