Role of Intrapartum Ultrasound in Instrumental Delivery

NCT02899481 | Terminated DMC

• 1 other identifier: CC-157
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Labor Complications

Outcome Measures

Primary Outcomes (2)

• Maternal and neonatal morbidity

  Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay

  2 years

• Neonatal morbidity

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

  2 years

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Transabdominal and transperineal ultrasound OTHER

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• fetal malformations
• emergency situation

Sponsors & Collaborators

• University of Lisbon: lead

Study Sites (1)

Centro Hospitalar Lisboa Norte - Hospital Santa Maria

Lisbon, Portugal

Location

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Joana Barros, MD

  University of Lisbon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: September 14, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)