NCT03184077

Brief Summary

To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to poliglecaprone 25 using a validated sexual function questionnaire. To assess maternal satisfaction with the laceration repair and suture material. To assess overall perineal pain using a visual analog scale. To assess the rate of wound breakdown and the need for suture removal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

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

September 2, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 8, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

April 19, 2017

Results QC Date

June 7, 2018

Last Update Submit

August 15, 2019

Conditions

DyspareuniaPerineal TearSutured Laceration

Keywords

Postpartum dyspareuniaObestric laceration

Outcome Measures

Primary Outcomes (1)

  • Rates of Dyspareunia

    To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to poliglecaprone 25 using a validated sexual function questionnaire, with higher scores indicating greater discomfort or pain. Scale used - Female Sexual Function Index -6 where 0 indicates no sexual activity, 1 indicates a worse outcome and 5 indicates a better outcome. The scale assesses sexual desire, arousal, lubrication, orgasm, sexual satisfaction and sexual pain. A score of 1 indicates very low desire, arousal, almost never or never becoming lubricated or achieving orgasm, being very dissatisfied with sexual life and almost always or always having pain with intercourse. A score of 5 indicates very high desire, arousal, almost always or always becoming lubricated or achieving orgasm, being very satisfied with sexual life and almost never or never having pain with intercourse.

    3 months postpartum

Secondary Outcomes (2)

  • Postpartum Pain

    6 weeks postpartum

  • Overall Sexual Function

    3 months

Study Arms (2)

Polyglactin 910

ACTIVE COMPARATOR
Procedure: Laceration Repair with Polyglactin 910

poliglecaprone 25

ACTIVE COMPARATOR
Procedure: Laceration Repair with poliglecaprone 25

Interventions

Laceration Repair with Polyglactin 910PROCEDURE

Polyglactin 910 suture for laceration repair

Polyglactin 910
Laceration Repair with poliglecaprone 25PROCEDURE

poliglecaprone 25 suture for laceration repair

poliglecaprone 25

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English speaking, patients with first and second degree spontaneous lacerations or those with midline or mediolateral epsiotomies that were uncomplicated, and hemodynamically stable paitents

You may not qualify if:

  • non-english speaking, women without laceration or with more extensive third or fourth degree lacerations, and inmates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Dyspareunia

Interventions

Polyglactin 910glycolide E-caprolactone copolymer

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

PolyestersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Lindsay Morrell, MD
Organization
Virginia Commonwealth University
lmorrellmcv@gmail.com
410-823-1120

Study Officials

  • Ashley W Carroll, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2017

First Posted

June 12, 2017

Study Start

September 2, 2014

Primary Completion

August 27, 2017

Study Completion

August 27, 2017

Last Updated

August 28, 2019

Results First Posted

August 8, 2018

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)