The Effect of the Modified Perineal Protection Device During Delivery

Perineal Tears. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02013752
• Other study ID #: KH-HBG-13
• Secondary ID: ONLY-HBG
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 1, 2013
• Last updated: March 18, 2015
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Helsingborgs Hospital
• Contact: Knut Haadem, M.D. PhD
• Phone: 0046739549946
• Email: knut.haadem[@]telia.se
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Vaginal delivery at term (week 36 - 41)

Exclusion Criteria:

• Age below 18

• Breech delivery

• Not understanding written and oral information

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Perineal Tears.

Intervention

Device:
• Perineal protection device.
A device used to reduce perineal tears during delivery of the baby.

Locations

Country	Name	City	State
Sweden	Dept Obstetrics and Gynecology, Helsingborg Hospital	Helsingborg	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Knut Haadem

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of delivery tear measured in cm with ruler	The outcome measured is the occurrence of first and second degree vaginal and perineal tears during delivery.	at delivery - Participants will be followed for the duration of the first 24 hours	Yes
Secondary	Adverse effects of the device on mother and child	Measure eventual adverse effects on mother and child.	at delivery-Participants will be followed for the duration of the first 24 hours	Yes