Clinical trial NCT03806348: Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence Among Women Who Had a Vaginal Delivery
Official title: Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound; Perineal Rupture, Dehiscence
Lead sponsor: Stockholm South General Hospital
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Woman over 18 years old who had a vaginal delivery and suffered from a perineal rupture, grade 2 (spontaneous or episiotomy).
* No longer than two weeks has passed since delivery.
* The woman must be able to give informed consent.

Exclusion Criteria:

* Perineal rupture grade 3 and 4.
* Woman suffering from connective tissue disease.
* Ongoing treatment with oral cortisone or other immunosuppressive disease.
* Diabetes treated with insulin.
* Suspicion of occult damage of the anal sphincter.
* Earlier surgery of the perineum.

Primary outcomes:
measure: Need of late perineal reconstruction
timeFrame: One year
Secondary outcomes:
measure: Pelvic floor symptoms and the impact on quality of life
timeFrame: One year
measure: Pelvic floor symptoms and the impact on quality of life
timeFrame: One year
measure: Sexual function
timeFrame: One year
measure: Wound healing
timeFrame: 2 weeks
measure: Wound healing
timeFrame: 4 weeks
measure: Pain intensity measure: NRS
timeFrame: From randomization to 4 weeks after.
measure: Secondary fear of childbirth
timeFrame: One year.
measure: Affected breastfeeding
timeFrame: 2 weeks
measure: Affected breastfeeding
timeFrame: 4 weeks
measure: Psychological wellbeing
timeFrame: 4 weeks
measure: Psychological wellbeing
timeFrame: One year.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Obstetrics and Gynecology, Stockholm South General Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Stockholm South General Hospital
name: Marion Ek, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: