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Role of Intrapartum Ultrasound in Instrumental Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02899481
Recruitment Status : Terminated (Data Safety Monitoring Committee recommended stopping the trial due to futility.)
First Posted : September 14, 2016
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Joana Barros, University of Lisbon

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.

Condition or disease Intervention/treatment Phase
Obstetric Labor Complications Other: Transabdominal and transperineal ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Study group
The study group will be constituted by pregnant women in whom the operative delivery will be preceded by a transabdominal and transperineal ultrasound to evaluate fetal head position and fetal head station, by means of determination of the 'angle of progression'.
Other: Transabdominal and transperineal ultrasound
Transabdominal ultrasound, for determining fetal head position, is performed with the pregnant women in supine position after bladder emptying, with the transducer placed transversely on the suprapubic region of the maternal abdomen. For the sonographic determination of the fetal descent we will perform a transperineal ultrasound achieved by placing the ultrasound transducer on the perineum in a mid sagittal position between the labia below the pubic symphysis.

No Intervention: Control group
The control group will be constituted by pregnant women in whom the operative delivery will be carried out based solely on clinical criteria, namely transvaginal digital examination.



Primary Outcome Measures :
  1. Maternal and neonatal morbidity [ Time Frame: 2 years ]
    Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay

  2. Neonatal morbidity [ Time Frame: 2 years ]
    low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899481


Locations
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Portugal
Centro Hospitalar Lisboa Norte - Hospital Santa Maria
Lisbon, Portugal
Sponsors and Collaborators
University of Lisbon
Investigators
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Principal Investigator: Joana Barros, MD University of Lisbon
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Responsible Party: Joana Barros, MD, University of Lisbon
ClinicalTrials.gov Identifier: NCT02899481    
Other Study ID Numbers: CC-157
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications