Role of Intrapartum Ultrasound in Instrumental Delivery

Obstetric Labor Complications Clinical Trial

Official title:

Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02899481
• Other study ID #: CC-157
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Obstetric Labor Complications

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