Dyspareunia Clinical Trial
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.
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.
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