Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effect of the Modified Perineal Protection Device During Delivery

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Helsingborgs Hospital
Information provided by (Responsible Party):
Knut Haadem, Helsingborgs Hospital Identifier:
First received: December 1, 2013
Last updated: December 11, 2013
Last verified: December 2013

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
Endpoint Classification: Efficacy Study
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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Measure eventual adverse effects on mother and child.

Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT02013752

Contact: Knut Haadem, M.D. PhD 0046739549946
Contact: Tony Lavesson, M.D 0046424062205

Dept Obstetrics and Gynecology, Helsingborg Hospital Recruiting
Helsingborg, Skåne, Sweden, 20587
Contact: Knut Haadem, MD, PhD    0046739549946   
Contact: Tony Lavesson, MD    0046424062205   
Principal Investigator: Tony Lavesson, MD         
Sponsors and Collaborators
Knut Haadem
Principal Investigator: Knut Haadem, M.D., PhD Campus Helsingborg, Clinical Science Faculty of Medicine, Lund University, Helsingborg, Sweden
  More Information

No publications provided

Responsible Party: Knut Haadem, M.D., PhD, Helsingborgs Hospital Identifier: NCT02013752     History of Changes
Other Study ID Numbers: KH-HBG-13, ONLY-HBG
Study First Received: December 1, 2013
Last Updated: December 11, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Helsingborgs Hospital:
Delivery tears
Birth injuries
Perineal protection device processed this record on March 03, 2015