The Effect of the Modified Perineal Protection Device During Delivery
Randomized Controlled Trial (RCT) of Primiparous Women Using the Modified Perineal Protection Device
2 other identifiers
interventional
100
1 country
1
Brief Summary
The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 17, 2013
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 19, 2015
March 1, 2015
6 months
December 1, 2013
March 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Adverse effects of the device on mother and child
at delivery-Participants will be followed for the duration of the first 24 hours
Study Arms (2)
Perineal device during delivery
ACTIVE COMPARATORDelivery 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
OTHERStandard care at delivery: Manual support of the perineum
Interventions
A device used to reduce perineal tears during delivery of the baby.
Eligibility Criteria
You may qualify if:
- Vaginal delivery at term (week 36 - 41)
You may not qualify if:
- Age below 18
- Breech delivery
- Not understanding written and oral information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Knut Haademlead
Study Sites (1)
Dept Obstetrics and Gynecology, Helsingborg Hospital
Helsingborg, Skåne County, 20587, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Knut Haadem, M.D., PhD
Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, Helsingborg, Sweden
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D., PhD
Study Record Dates
First Submitted
December 1, 2013
First Posted
December 17, 2013
Study Start
March 1, 2015
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
March 19, 2015
Record last verified: 2015-03