N/A
Completed N=318
Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair
Dyspareunia · Perineal Tear · Sutured Laceration
Source: ClinicalTrials.gov NCT03184077 ↗
Enrolled (actual)
318
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Rates of Dyspareunia — 3.6; 3.49 units on a scale — p=0.16
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Dyspareunia |
3.6; 3.49 | 0.16 |
| SECONDARY Postpartum Pain |
.85; .83 | 0.62 |
| SECONDARY Overall Sexual Function |
2.87; 2.51 | 0.01 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03184077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.