The Effect of the Modified Perineal Protection Device During Delivery

March 18, 2015 updated by: Knut Haadem

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Helsingborg, Skåne, Sweden, 20587
        • Recruiting
        • Dept Obstetrics and Gynecology, Helsingborg Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tony Lavesson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Vaginal delivery at term (week 36 - 41)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Perineal device during delivery
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.
Device: Perineal protection device.
A device used to reduce perineal tears during delivery of the baby.
Other Names:
  • The perineal protection device have no brand name.
Other: Standard care
Standard care at delivery: Manual support of the perineum
Device: Perineal protection device.
A device used to reduce perineal tears during delivery of the baby.
Other Names:
  • The perineal protection device have no brand name.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at delivery - Participants will be followed for the duration of the first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at delivery-Participants will be followed for the duration of the first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Knut Haadem

Investigators

  • Principal Investigator: Knut Haadem, M.D., PhD, Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, Helsingborg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 1, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KH-HBG-13
  • ONLY-HBG (Registry Identifier: KH-HBG-13)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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