Clinical Trial: The Effect of the Modified Perineal Protection Device During Delivery

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Controlled Trial (RCT) of Primiparous Women Using the Modified Perineal Protection Device

Brief Summary: The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.

Detailed Summary: RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.
Sponsor: Knut Haadem

Current Primary Outcome: Length of delivery tear measured in cm with ruler [ Time Frame: at delivery - Participants will be followed for the duration of the first 24 hours ]

The outcome measured is the occurrence of first and second degree vaginal and perineal tears during delivery.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse effects of the device on mother and child [ Time Frame: at delivery-Participants will be followed for the duration of the first 24 hours ]

Measure eventual adverse effects on mother and child.


Original Secondary Outcome: Same as current

Information By: Helsingborgs Hospital

Dates:
Date Received: December 1, 2013
Date Started: March 2015
Date Completion: December 2015
Last Updated: March 18, 2015
Last Verified: March 2015