Prediction of Uterine Atony After Vaginal Delivery by Elastography

NCT ID: NCT04267783

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-05-30

Brief Summary

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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

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Conditions

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Postpartum Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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 .

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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DAVID DESSEAUVE

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Lausanne

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-02267

Identifier Type: -

Identifier Source: org_study_id

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