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Prediction of Uterine Atony After Vaginal Delivery by Elastography

V

Vaud University Hospital Center

Status

Completed

Conditions

Postpartum Hemorrhage

Treatments

Diagnostic Test: Shear wave elastography

Study type

Observational

Funder types

Other

Identifiers

NCT04267783
2018-02267

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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