Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence Among Women Who Had a Vaginal Delivery

Stockholm South General Hospital

Status: Unknown

Conditions: Wound; Perineal Rupture, Dehiscence

Treatments: Procedure: Resuturing

Study type: Interventional

Funder types: Other

Identifiers

NCT03806348

Paris2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Resuturing

Experimental group

Description:

Early resuturing of perineal wound dehiscence. Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.

Treatment:

Procedure: Resuturing

Conservative treatment

No Intervention group

Description:

Antibiotics: Amoxicillin 500 mg, Clavulanic Acid 125 mg and Metronidazole 400 mg by mouth, every 8 hours, for at least 6 Days.