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The Effect of Primary Delivery of the Anterior Compared With the Posterior Shoulder on Perineal Trauma: a Randomized Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01937546
First Posted: September 9, 2013
Last Update Posted: July 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanne Willer, Holbaek Sygehus
  Purpose
It is unknown if primary delivery of the anterior or the posterior shoulder causes less perineal tear. The objective of this trial is to evaluate the incidence and degree of perineal trauma after primary delivery of the anterior shoulder compared to primary delivery of the posterior shoulder during vaginal birth in primiparous women in a randomized controlled trial. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Primary Delivery of the Anterior Compared With the Posterior Shoulder on Perineal Trauma: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hanne Willer, Holbaek Sygehus:

Primary Outcome Measures:
  • Number of patients with perineal tears [ Time Frame: perineal tears are evaluated within 1 hour of delivery ]
    Any perineal tear requiring suturing


Secondary Outcome Measures:
  • pH in umbilical artery [ Time Frame: Evaluated within 5 minutes of delivery ]
    Arterial pH in the umbilical artery

  • apgar score [ Time Frame: 5 minutes ]
    Apgar-score 5 minutes after delivery

  • neonatal birth trauma [ Time Frame: 2 hours ]
    Neonatal birth trauma including fractures of the clavicle and humerus, and brachial plexus injury.

  • Post partum bleeding [ Time Frame: 2 hours post partum ]
    postpartum bleeding in millilitres evaluated 2 hours after birth

  • the perineal injury subtypes [ Time Frame: Within 1 hour after delivery ]
    Labia laceration, Perineal tear grade I-IV or episiotomy.


Enrollment: 650
Study Start Date: January 2013
Study Completion Date: July 2015
Primary Completion Date: March 2015 (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 posterior shoulder of the fetus
Procedure: Primary delivery posterior shoulder

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937546


Locations
Denmark
Dept. Obstetrics and Gynaecology, University of Copenhagen Holbaek Hospital
Holbaek, Denmark, 4300
Sponsors and Collaborators
Holbaek Sygehus
Investigators
Principal Investigator: Hanne Willer Dept. Obstetrics and Gynaecology, University of Copenhagen Holbaek Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanne Willer, Midwife, Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT01937546     History of Changes
Other Study ID Numbers: SJ-310
First Submitted: August 30, 2013
First Posted: September 9, 2013
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Hanne Willer, 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
Infant, Newborn, Diseases
Wounds and Injuries