Overview

This trial is active, not recruiting.

Condition (delivery trauma to perineum) or (perineal tear)
Sponsor University of Zurich
Start date February 2015
End date December 2016
Trial size 120 participants
Trial identifier NCT02295904, KEK-ZH-Nr.2014-0414

Summary

Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
adequate support of perineum
time frame: 12 months

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - Pregnant women, - at least 18 years of age (yoa), - term deliveries (at least 37+0 weeks of gestation), - vaginal delivery, - fetal vertex presentation, - single pregnancy Exclusion Criteria: - younger than 18 yoa, - preterm deliveries, - cesarean sections, - fetal malformations, - maternal disease in form of collagenosis, - multiples pregnancy, - vaginal/vulvar/perineal pre-operations (excluding birth trauma), - perineal birth trauma grade III+IV

Additional Information

Official title Video Analysis of Vaginal Deliveries to Evaluate the Impact of the Support of the Perineum
Principal investigator Nina Kimmich, MD
Description Documentation of support of perineum via video camera, documentation of birth trauma after delivery, record of fetal and maternal parameters as weight, hight, fetal presentation, etc.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Zurich.