NCT01937546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

August 30, 2013

Last Update Submit

July 23, 2015

Conditions

Birth Injuries

Keywords

Anal Canal/injuriesDelivery, Obstetric/methodsLabour Stage, SecondLacerations/prevention & controlObstetric Labour Complications/prevention & controlperineum/injuries

Outcome Measures

Primary Outcomes (1)

  • Number of patients with perineal tears

    Any perineal tear requiring suturing

    perineal tears are evaluated within 1 hour of delivery

Secondary Outcomes (5)

  • pH in umbilical artery

    Evaluated within 5 minutes of delivery

  • apgar score

    5 minutes

  • neonatal birth trauma

    2 hours

  • Post partum bleeding

    2 hours post partum

  • the perineal injury subtypes

    Within 1 hour after delivery

Study Arms (2)

Anterior shoulder

ACTIVE COMPARATOR

Primary delivery of the anterior shoulder of the fetus

Procedure: Primary delivery of anterior shoulder

Posterior shoulder

EXPERIMENTAL

Primary delivery of the posterior shoulder of the fetus

Procedure: Primary delivery posterior shoulder

Interventions

Primary delivery of anterior shoulderPROCEDURE
Anterior shoulder
Primary delivery posterior shoulderPROCEDURE
Posterior shoulder

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • nullipara
  • primipara with previous cesarean section

You may not qualify if:

  • Multipara
  • Twin pregnancies
  • Nullipara with elective cesarean section
  • Preterm delivery before 35 gestational weeks
  • Breech delivery
  • Acute cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Obstetrics and Gynaecology, University of Copenhagen Holbaek Hospital

Holbæk, 4300, Denmark

Location

Related Publications (1)

  • Willer H, Aabakke AJ, Krebs L. The effect of primary delivery of the anterior compared with the posterior shoulder on perineal trauma: a study protocol for a randomized controlled trial. Trials. 2014 Jul 21;15:291. doi: 10.1186/1745-6215-15-291.

    PMID: 25047001DERIVED

Related Links

MeSH Terms

Conditions

Birth InjuriesWounds and InjuriesNeoplasm MetastasisLacerations

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hanne Willer

    Dept. Obstetrics and Gynaecology, University of Copenhagen Holbaek Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 9, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

DK(1)