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Clinical Trials/NCT02013752
NCT02013752
Unknown
Phase 2

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

Knut Haadem1 site in 1 country100 target enrollmentMarch 2015
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ConditionsPerineal Tears.

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Perineal Tears.
Sponsor
Knut Haadem
Enrollment
100
Locations
1
Primary Endpoint
Length of delivery tear measured in cm with ruler
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Knut Haadem
Responsible Party
Sponsor Investigator
Principal Investigator

Knut Haadem

M.D., PhD

Helsingborgs Hospital

Eligibility Criteria

Inclusion Criteria

  • •Vaginal delivery at term (week 36 - 41)

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Adverse effects of the device on mother and child(at delivery-Participants will be followed for the duration of the first 24 hours)

Study Sites (1)

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