Dyspareunia, Perineal Tear, Sutured Laceration
Conditions
Keywords
Postpartum dyspareunia, Obestric laceration
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.
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.
Interventions
PROCEDURELaceration Repair with Polyglactin 910
Polyglactin 910 suture for laceration repair
PROCEDURELaceration Repair with poliglecaprone 25
poliglecaprone 25 suture for laceration repair
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking, patients with first and second degree spontaneous lacerations or those with midline or mediolateral epsiotomies that were uncomplicated, and hemodynamically stable paitents
Exclusion criteria
* non-english speaking, women without laceration or with more extensive third or fourth degree lacerations, and inmates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Dyspareunia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum Pain | 6 weeks postpartum | 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. |
| Overall Sexual Function | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polyglactic 910 (Vicryl Rapide) Laceration Repair with Polyglactic 910 (Vicryl Rapide): Polyglactic 910 suture for laceration repair | 145 |
| Monocryl Laceration Repair with Monocryl: Monocryl suture for laceration repair | 131 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 21 |
Baseline characteristics
| Characteristic | Total | Polyglactic 910 (Vicryl Rapide) | Monocryl |
|---|---|---|---|
| Age, Continuous | 27.4 years | 27.4 years | 27.6 years |
| Race/Ethnicity, Customized Asian | 9 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 114 Participants | 63 Participants | 51 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants | 6 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 24 Participants | 12 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 122 Participants | 60 Participants | 62 Participants |
| Region of Enrollment United States | 318 participants | 145 participants | 131 participants |
| Sex: Female, Male Female | 276 Participants | 145 Participants | 131 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 152 |
| other Total, other adverse events | 0 / 166 | 0 / 152 |
| serious Total, serious adverse events | 0 / 166 | 0 / 152 |
Outcome results
Primary
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.
Time frame: 3 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polyglactin 910 (Vicryl Rapide) | Rates of Dyspareunia | 3.6 units on a scale | Standard Deviation 1.4 |
| Poliglecaprone 25 | Rates of Dyspareunia | 3.49 units on a scale | Standard Deviation 1.47 |
p-value: 0.16Chi-squared
Secondary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polyglactin 910 (Vicryl Rapide) | Overall Sexual Function | 2.87 units on a scale | Standard Deviation 1.4 |
| Poliglecaprone 25 | Overall Sexual Function | 2.51 units on a scale | Standard Deviation 1.47 |
p-value: 0.01Chi-squared
Secondary
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.
Time frame: 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polyglactin 910 (Vicryl Rapide) | Postpartum Pain | .85 units on a scale | Standard Deviation 1.67 |
| Poliglecaprone 25 | Postpartum Pain | .83 units on a scale | Standard Deviation 1.62 |
p-value: 0.62Chi-squared