Role of Intrapartum Ultrasound in Instrumental Delivery

Not Applicable

Terminated

• Conditions: Obstetric Labor Complications

• Registration Number: NCT02899481
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-06
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-14
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-20
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 222

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal and neonatal morbidity	2 years	Severe postpartum hemorrhage, perineal trauma, prolonged hospital stay
Neonatal morbidity	2 years	low 5-minute Apgar score, umbilical artery metabolic acidosis, birth trauma and neonatal intensive care unit admission

Trial Locations

Locations (1)

Centro Hospitalar Lisboa Norte - Hospital Santa Maria; 🇵🇹 Lisbon, Portugal