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
Information provided by (Responsible Party):
Hanne Willer, Holbaek Sygehus Identifier:
First received: August 30, 2013
Last updated: September 4, 2013
Last verified: September 2013

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


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01937546

Contact: Hanne Willer +45 40616047
Contact: Anna Aabakke, M.D. +45 26279426

Dept. Obstetrics and Gynaecology, University of Copenhagen Holbaek Hospital Recruiting
Holbaek, Denmark, 4300
Contact: Hanne Willer    +45 40616047   
Contact: Lone Krebs, M.D.; DMSCi    +45 59484264   
Principal Investigator: Hanne Willer         
Sponsors and Collaborators
Holbaek Sygehus
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 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

Additional relevant MeSH terms:
Birth Injuries
Wounds and Injuries
Infant, Newborn, Diseases processed this record on April 17, 2014