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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hanne Willer, Holbaek Sygehus
ClinicalTrials.gov Identifier:
NCT01937546
First received: August 30, 2013
Last updated: June 27, 2014
Last verified: June 2014
  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
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: 5 minutes ] [ Designated as safety issue: No ]
    Apgar-score 5 minutes after delivery

  • neonatal birth trauma [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Neonatal birth trauma including fractures of the clavicle and humerus, and brachial plexus injury.

  • Post partum bleeding [ Time Frame: 2 hours post partum ] [ Designated as safety issue: No ]
    postpartum bleeding in millilitres evaluated 2 hours after birth

  • the perineal injury subtypes [ Time Frame: Within 1 hour after delivery ] [ Designated as safety issue: No ]
    Perineal tear grade I-IV


Estimated Enrollment: 650
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 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 posterior shoulder of the fetus
Procedure: Primary delivery posterior shoulder

  Show Detailed Description

  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
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 ClinicalTrials.gov identifier: 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

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: June 27, 2014
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 July 23, 2014