Wound; Perineal Rupture, Dehiscence Clinical Trial
Official title:
Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence: a Randomised Controlled Trial
Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after being sutured sometimes dehisced after days up to a few weeks and this study will investigate whether it is better to resuture early or leave the rupture for secondary healing.
140 women will be included in the trial, 70 women will be randomized to resuturing and 70
women will be randomized to expectant management. The investigators will follow the women
with clinical investigations after 2 and 4 weeks. After two weeks the healing will be
measured using the REEDA scale and the women will be asked whether they breastfeed or not.
The psychological wellbeing will be measured using the EPDS (Edinburgh Postnatal Depression
Scale).
After four weeks the above will be done again as well as collecting of the daily pain diary
that the women have filled in since being included in the trial.
After one year the women will be seen again and the investigators will do a clinical
investigation including ultrasound of the perineal body, measurement of the perineal body,
POP-Q ( Pelvic Organ Prolapse Quantification System) as well as multiple validated scales as
EPDS, FSFI ( Female Sexual Function Index), PFIQ (Pelvic Floor Impact Questionnaire) and PFDI
(Pelvic Floor Distress Inventory). These scales will help the investigators to find out if
the women have moderate to much trouble with vaginal wideness and/ or moderate to much
problems during defecation and therefore, if the perineal body is palpated smaller than 2 cm,
there will be indication for a perineal reconstruction.
The primary outcome will be to investigate whether early resuturing is reducing the need of a
later secondary reconstruction of the perineal body compared with conservative management
concerning dehisced perineal wounds.
The secondary outcomes will be to investigate whether early resuturing is reducing the risk
of having symptoms from the perineum and/or sexual problems one year after delivery.
The healing of the wound and the estimated pain will be compared between the two groups.
Certain questions concerning secondary fear of childbirth will also be asked and compared
between the two groups.
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