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

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ClinicalTrials.gov Identifier: NCT01937546
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hanne Willer, Holbaek Sygehus

Brief Summary:
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 or disease Intervention/treatment Phase
Birth Injuries Procedure: Primary delivery of anterior shoulder Procedure: Primary delivery posterior shoulder Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
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
Study Start Date : January 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. pH in umbilical artery [ Time Frame: Evaluated within 5 minutes of delivery ]
    Arterial pH in the umbilical artery

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

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

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

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



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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

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 Posted: September 9, 2013    Key Record Dates
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