DyspareuniaNCT03184077
Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair
A study testing Laceration Repair with Polyglactin 910 and Laceration Repair with poliglecaprone 25 in people with Dyspareunia and Perineal Tear, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyspareunia, Perineal Tear, Sutured Laceration
- What is being tested?
- Laceration Repair with Polyglactin 910 and Laceration Repair with poliglecaprone 25
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2014to 27 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speaking, patients with first and second degree spontaneous lacerations or those with midline or mediolateral epsiotomies that were uncomplicated, and hemodynamically stable paitents
Who cannot join
- non-english speaking, women without laceration or with more extensive third or fourth degree lacerations, and inmates
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair: A Randomized Controlled Trial
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.
Read the detailed description
This randomized controlled trial will be conducted and VCU medical center comparing 2 types of suture: rapidly absorbing polyglactin 910 (Vicryl Rapide) and poliglecaprone 25 (Monocryl) for first and second-degree lacerations requiring suture repair. Patients will be enrolled in the study immediately after vaginal delivery if a laceration occurs spontaneously. Patients will be randomized to one of the 2 sutures after enrollment.
Randomization will be obtained via computer generation in consecutively numbered, opaque sealed envelopes with the name of one of the suture materials. The envelope will be opened at the time of repair of perineal laceration once inclusion criteria have been met by the physician or midwife performing the laceration repair. Repair with the chosen suture will be performed using the continuous suture technique using a 3-0 suture, which is current standard practice. Patients will not be informed of the type of suture used, although the type of suture will be recorded in the patient's electronic medical record. Various maternal and fetal characteristics will be recorded including maternal age, gravity and parity, gestational age at delivery, birth weight, mode of vaginal delivery (spontaneous or operative).
Pain will be evaluated using a numeric pain scale at their 6 week postpartum visit and at 3 months postpartum via a telephone interview. At 3 months postpartum they will also be asked the following questions - Have you resumed sexual intercourse(yes/no)? How long after delivery was it before you resumed intercourse? Did you have pain the first time after delivery (yes/no)? Do you have continued dyspareunia (1-10)? Do you have residual perineal pain unrelated to intercourse? How satisfied are you with your laceration repair (very unsatisfied -1, neutral-3, very satisfied- 5). They will also be administered a 6 question validated Female Sexual Function Index.
- Conditions
- Dyspareunia, Perineal Tear, Sutured Laceration
- Being tested
- Laceration Repair with Polyglactin 910, Laceration Repair with poliglecaprone 25
- Keywords
- Postpartum dyspareunia, Obestric laceration
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laceration Repair with Polyglactin 910Procedure or surgery
Polyglactin 910 suture for laceration repair
Laceration Repair with poliglecaprone 25Procedure or surgery
poliglecaprone 25 suture for laceration repair
| Study group | Role | What they receive |
|---|---|---|
| Polyglactin 910 | Active comparator | Not described Receives: Procedure: Laceration Repair with Polyglactin 910 |
| poliglecaprone 25 | Active comparator | Not described Receives: Procedure: Laceration Repair with poliglecaprone 25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months postpartum
Secondary outcomes (2)
Postpartum Pain
To assess overall perineal pain using a visual analog scale on a range of 0-10, with 0 being no pain and 10 being worst imaginable pain Scale used - Pain Numeric Rating Scale. A minimal score of 0 indicates no pain whereas a maximums core of 10 indicates the worse imaginable pain.
Measured: 6 weeks postpartum
Overall Sexual Function
Level of sexual desire or interest on a scale of 1-5, with 5 being the highest level of interest
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start2 Sep 2014
- Primary completion27 Aug 2017
- Study completion27 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley W Carroll, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184077
- Sponsor's protocol ID
- HM20000992
- Status last verified
- Aug 2019
- First submitted
- 19 Apr 2017
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03184077
- Acronym / sponsor ID
- HM20000992
- Conditions
- Dyspareunia, Perineal Tear, Sutured Laceration
- Keywords
- Postpartum dyspareunia, Obestric laceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- 27 Aug 2017 (actual)
- Study completion
- 27 Aug 2017 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled trial will be conducted and VCU medical center comparing 2 types of suture: rapidly absorbing polyglactin 910 (Vicryl Rapide) and poliglecaprone 25 (Monocryl) for first and second-degree lacerations requiring suture repair. Patients will be enrolled in the study immediately after vaginal delivery if a laceration occurs spontaneously. Patients will be randomized to one of the 2 sutures after enrollment.
Randomization will be obtained via computer generation in consecutively numbered, opaque sealed envelopes with the name of one of the suture materials. The envelope will be opened at the time of repair of perineal laceration once inclusion criteria have been met by the physician or midwife performing the laceration repair. Repair with the chosen suture will be performed using the continuous suture technique using a 3-0 suture, which is current standard practice. Patients will not be informed of the type of suture used, although the type of suture will be recorded in the patient's electronic medical record. Various maternal and fetal characteristics will be recorded including maternal age, gravity and parity, gestational age at delivery, birth weight, mode of vaginal delivery (spontaneous or operative).
Pain will be evaluated using a numeric pain scale at their 6 week postpartum visit and at 3 months postpartum via a telephone interview. At 3 months postpartum they will also be asked the following questions - Have you resumed sexual intercourse(yes/no)? How long after delivery was it before you resumed intercourse? Did you have pain the first time after delivery (yes/no)? Do you have continued dyspareunia (1-10)? Do you have residual perineal pain unrelated to intercourse? How satisfied are you with your laceration repair (very unsatisfied -1, neutral-3, very satisfied- 5). They will also be administered a 6 question validated Female Sexual Function Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyglactin 910 | Active comparator | Procedure: Laceration Repair with Polyglactin 910 |
| poliglecaprone 25 | Active comparator | Procedure: Laceration Repair with poliglecaprone 25 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- English speaking, patients with first and second degree spontaneous lacerations or those with midline or mediolateral epsiotomies that were uncomplicated, and hemodynamically stable paitents
Key exclusion criteria (1 listed)
- non-english speaking, women without laceration or with more extensive third or fourth degree lacerations, and inmates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laceration Repair with Polyglactin 910Polyglactin 910 suture for laceration repair | Procedure or surgery | Polyglactin 910 |
| Laceration Repair with poliglecaprone 25poliglecaprone 25 suture for laceration repair | Procedure or surgery | poliglecaprone 25 |
Primary outcome
Rates of Dyspareunia
Time frame: 3 months postpartum
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.
2 secondary outcomes
Postpartum Pain
Time frame: 6 weeks postpartum
Overall Sexual Function
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley W Carroll, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laceration Repair with Polyglactin 910 and Laceration Repair with poliglecaprone 25 in people with Dyspareunia and Perineal Tear, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Dyspareunia (time frame: 3 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.