The Effect of Primary Delivery of the Anterior Versus Posterior Shoulder on Perineal Tears: a Randomized Controlled Trial

This study is currently recruiting participants.
Verified September 2013 by Holbaek Sygehus
Sponsor:
Information provided by (Responsible Party):
Hanne Willer, Holbaek Sygehus
ClinicalTrials.gov Identifier:
NCT01937546
First received: August 30, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

It is unknown if primary delivery of the anterior or the posterior shoulder causes less perineal tear. The objective of this study is to compare primary delivery of either the anterior or posterior shoulder. Number of and grade of perineal tear is the primary outcome.


Condition Intervention
Birth Injuries
Procedure: Primary delivery of anterior shoulder
Procedure: Primary delivery posterior shoulder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Holbaek Sygehus:

Primary Outcome Measures:
  • Number of patients with perineal tears [ Time Frame: perineal tears are evaluated within 1 hour of delivery ] [ Designated as safety issue: No ]
    Perineal tear of grade I-IV


Secondary Outcome Measures:
  • pH in umbilical artery [ Time Frame: Evaluated within 5 minutes of delivery ] [ Designated as safety issue: No ]
    Arterial pH in the umbilical artery

  • apgar score [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    Apgar-score 10 minutes after delivery

  • fetal injury [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Fetal injury acquired during birth, eg. fractured claviculae, fractured humerus, brachial plexus injury


Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterior shoulder
Primary delivery of the anterior shoulder of the fetus
Procedure: Primary delivery of anterior shoulder
Experimental: Posterior shoulder
Primary delivery of the postterior shoulder of the fetus
Procedure: Primary delivery posterior shoulder

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • nullipara
  • primipara with previous cesarean section

Exclusion Criteria:

  • Multipara
  • Twin pregnancies
  • Nullipara with elective cesarean section
  • Preterm delivery before 35 gestational weeks
  • Breech delivery
  • Acute cesarean section
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01937546

Contacts
Contact: Hanne Willer +45 40616047 hwr@regionsjaelland.dk
Contact: Anna Aabakke, M.D. +45 26279426 aabakke@gmail.com

Locations
Denmark
Dept. Obstetrics and Gynaecology, University of Copenhagen Holbaek Hospital Recruiting
Holbaek, Denmark, 4300
Contact: Hanne Willer    +45 40616047    hwr@regionsjaelland.dk   
Contact: Lone Krebs, M.D.; DMSCi    +45 59484264    lkrb@regionsjaelland.dk   
Principal Investigator: Hanne Willer         
Sponsors and Collaborators
Holbaek Sygehus
Investigators
Principal Investigator: Hanne Willer Dept. Obstetrics and Gynaecology, University of Copenhagen Holbaek Hospital
  More Information

No publications provided

Responsible Party: Hanne Willer, Midwife, Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT01937546     History of Changes
Other Study ID Numbers: SJ-310
Study First Received: August 30, 2013
Last Updated: September 4, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Holbaek Sygehus:
Anal Canal/injuries
Delivery, Obstetric/methods
Labour Stage, Second
Lacerations/prevention & control
Obstetric Labour Complications/prevention & control
perineum/injuries

Additional relevant MeSH terms:
Birth Injuries
Wounds and Injuries
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 17, 2014