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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02899481
Other study ID # CC-157
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date March 2019

Study information

Verified date June 2020
Source University of Lisbon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 222
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Portugal Centro Hospitalar Lisboa Norte - Hospital Santa Maria Lisbon

Sponsors (1)

Lead Sponsor Collaborator
University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maternal and neonatal morbidity Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay 2 years
Primary Neonatal morbidity low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission 2 years
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