NCT02545218

Brief Summary

The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. The aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

September 7, 2015

Last Update Submit

August 22, 2018

Conditions

Perineal Tear Resulting From Childbirth

Keywords

Perineum. Perineorraphy. Pelvic floor exercise.

Outcome Measures

Primary Outcomes (1)

  • Patient Global Impression of Improvement (PGI-1)

    Patients own assessment of improvement 6 months after intervention using a seven grade assessment tool called PGI-1

    6 months after intervention (operation or start of pelvic floor training)

Secondary Outcomes (8)

  • POP-Q (Pelvic organ Quantification System)

    6 months after intervention (operation or start of pelvic floor training)

  • Ultrasound of perineum

    6 months after intervention (operation or start of pelvic floor training)

  • Pelvic floor distress inventory (PFDI 20)

    6 months after intervention (operation or start of pelvic floor training)

  • Pelvic Floor Impact Questionnaire (PIFQ-7)

    6 months after intervention (operation or start of pelvic floor training)

  • Prolapse Incontinence Sexual Questionnaire (PISQ)

    6 months after intervention (operation or start of pelvic floor training)

  • +3 more secondary outcomes

Study Arms (2)

Perineorraphy.

ACTIVE COMPARATOR

Secondary surgical repair of the perineal body. Operation is performed by a urogynecologist in an operation theater in local anesthesia. The operation aims to re-create the anatomy in the injured perineum using 2-4 sutures.

Procedure: Perineorraphy

Pelvic floor exercise.

ACTIVE COMPARATOR

Tutored pelvic floor exercise. A trained physio therapist evaluate the pelvic floor musculature and helps the patient to perform proper pelvic floor exercises using biofeedback. The patient receives a training scheme and meets the therapist regularly every second week during 4 months.

Other: Pelvic floor exercise

Interventions

PerineorraphyPROCEDURE

Surgery for improperly healed perineal tear

Perineorraphy.
Pelvic floor exerciseOTHER

Pelvic floor exercise tutored by physio therapist.

Pelvic floor exercise.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor
  • height of perineum 2 cm or less.
  • A least 6 months post partum
  • stopped "exclusive breastfeeding"
  • no indication for other gynecological surgical procedure

You may not qualify if:

  • history of 4th degree laceration
  • connective tissue disorder (Systemic lupus erythematosus, Sjögrens syndrome, Polymyalgia rheumatica, Marfans syndrome, Ehlers-Danlos syndrome)
  • current use of systemic corticosteroids
  • diabetes mellitus
  • suspect occult sphincter tear on ultrasound
  • history of previous urogynecological operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Södersjukhuset

Stockholm, 11861, Sweden

Location

Related Publications (3)

  • Woodman PJ, Graney DO. Anatomy and physiology of the female perineal body with relevance to obstetrical injury and repair. Clin Anat. 2002 Aug;15(5):321-34. doi: 10.1002/ca.10034.

    PMID: 12203375BACKGROUND

  • Harvey MA. Pelvic floor exercises during and after pregnancy: a systematic review of their role in preventing pelvic floor dysfunction. J Obstet Gynaecol Can. 2003 Jun;25(6):487-98. doi: 10.1016/s1701-2163(16)30310-3.

    PMID: 12806450RESULT

  • Bergman I, Westergren Soderberg M, Ek M. Perineorrhaphy Compared With Pelvic Floor Muscle Therapy in Women With Late Consequences of a Poorly Healed Second-Degree Perineal Tear: A Randomized Controlled Trial. Obstet Gynecol. 2020 Feb;135(2):341-351. doi: 10.1097/AOG.0000000000003653.

    PMID: 31923073DERIVED

Study Officials

  • Marion Ek, M.D., Ph.D.

    Stockholm South General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Ph.D.

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 9, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2019

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

SE(1)