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Clinical Trials/NCT02899481
NCT02899481
Terminated
Not Applicable

Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery

University of Lisbon1 site in 1 country222 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstetric Labor Complications
Sponsor
University of Lisbon
Enrollment
222
Locations
1
Primary Endpoint
Maternal and neonatal morbidity
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
March 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joana Barros

MD

University of Lisbon

Eligibility Criteria

Inclusion Criteria

  • pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound
  • live singleton pregnancy
  • fetus in a cephalic presentation
  • in the second stage of labor, after the decision to perform an instrumental delivery

Exclusion Criteria

  • fetal malformations
  • emergency situation

Outcomes

Primary Outcomes

Maternal and neonatal morbidity

Time Frame: 2 years

Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay

Neonatal morbidity

Time Frame: 2 years

low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission

Study Sites (1)

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