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The Effect of the Modified Perineal Protection Device During Delivery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Knut Haadem, Helsingborgs Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Knut Haadem, Helsingborgs Hospital
ClinicalTrials.gov Identifier:
NCT02013752
First received: December 1, 2013
Last updated: March 18, 2015
Last verified: March 2015
  Purpose
The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.

Condition Intervention Phase
Perineal Tears. Device: Perineal protection device. Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial (RCT) of Primiparous Women Using the Modified Perineal Protection Device

Resource links provided by NLM:


Further study details as provided by Knut Haadem, Helsingborgs Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: March 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: The perineal protection device have no brand name.
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 Name: The perineal protection device have no brand name.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vaginal delivery at term (week 36 - 41)

Exclusion Criteria:

  • Age below 18
  • Breech delivery
  • Not understanding written and oral information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013752

Contacts
Contact: Knut Haadem, M.D. PhD 0046739549946 knut.haadem@telia.se
Contact: Tony Lavesson, M.D 0046424062205 tony.lavesson@skane.se

Locations
Sweden
Dept Obstetrics and Gynecology, Helsingborg Hospital Recruiting
Helsingborg, Skåne, Sweden, 20587
Contact: Knut Haadem, MD, PhD    0046739549946    knut.haadem@telia.com   
Contact: Tony Lavesson, MD    0046424062205    tony.lavesson@skane.se   
Principal Investigator: Tony Lavesson, MD         
Sponsors and Collaborators
Knut Haadem
Investigators
Principal Investigator: Knut Haadem, M.D., PhD Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, Helsingborg, Sweden
  More Information

Responsible Party: Knut Haadem, M.D., PhD, Helsingborgs Hospital
ClinicalTrials.gov Identifier: NCT02013752     History of Changes
Other Study ID Numbers: KH-HBG-13
ONLY-HBG ( Registry Identifier: KH-HBG-13 )
Study First Received: December 1, 2013
Last Updated: March 18, 2015

Keywords provided by Knut Haadem, Helsingborgs Hospital:
Delivery tears
Birth injuries
Perineal protection device

ClinicalTrials.gov processed this record on June 26, 2017