The Effect of the Modified Perineal Protection Device During Delivery

Phase 2

• Conditions: Perineal Tears.
• Interventions: Device: Perineal protection device.

• Registration Number: NCT02013752
• Lead Sponsor: Knut Haadem

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-12-01
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Status Verified: 2015-03
• Study Start: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Vaginal delivery at term (week 36 - 41)

Exclusion Criteria

• Age below 18
• Breech delivery
• Not understanding written and oral information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perineal device during delivery	Perineal protection device.	Delivery should be managed by using the perineal protection device when the head was crowning and 5-6 cm of it was visible. One part the "tongue" was inserted between the head and the posterior vaginal wall and the "two wings" were held against the perineum and kept in place by the delivery attendant's hand.
Standard care	Perineal protection device.	Standard care at delivery: Manual support of the perineum

Primary Outcome Measures

Name	Time	Method
Length of delivery tear measured in cm with ruler	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.

Secondary Outcome Measures

Name	Time	Method
Adverse effects of the device on mother and child	at delivery-Participants will be followed for the duration of the first 24 hours	Measure eventual adverse effects on mother and child.

Trial Locations

Locations (1)

Dept Obstetrics and Gynecology, Helsingborg Hospital; 🇸🇪 Helsingborg, Skåne, Sweden