Clinical trial NCT05830162: Oral Antibiotics After Obstetric Perineal Tear
Official title: Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstetric Trauma
Infections
Wound Dehiscence
Keywords: obstetric tear
women's health
antibiotics
infection
wound dehiscence
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Region Hovedstadens Apotek
First posted: 2023-04-26
Enrollment: 442
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: The purpose of this study is to investigate if 3 dose of oral antibiotics administrated the first day after a vaginal delivery with a second degree obstetric tear will decrease the risk of infection and/or wound dehiscence compared to women with 3 doses of placebo treatment.

Detailed description: Background:

Obstetric tear occurs in more than 90% of nulliparous women and up to 25% subsequently experience wound dehiscence and/or infection. Some data shows that intravenous antibiotics given during delivery reduces this risk. It is unknown if oral antibiotics given after delivery can reduce the risk of wound dehiscence or infection.

The study-goupe want to investigate whether three doses of antibiotics (amoxicillin 500 mg / clavulanic acid 125 mg) given after delivery can reduce the risk of wound dehiscence and infection.

Methods:

The investigators will perform a randomized, controlled, double-blinded study and plan to include 221 women in each arm with allocation 1:1 in relation to the randomization. The study is carried out at Department of Obstetrics \& Gynecology, Herlev University Hospital, Copenhagen, Denmark. The women will be included after delivery if they have had a second-degree tear or episiotomy. The first tabelt has to be taken with in 6 hours from the delivery. After inclusion, the women will have a clinical follow up visit after one week. The tear and healing will be evaluated regarding infection and/or dehiscence. The women will again be invited for a one year clinical examination including ultrasound. Questionaries exploring symptoms related to the vaginal tear and possible complications will be answered at both visits.

The primary outcome is wound dehiscence and/or wound infection, which will be calculated using χ2-tests to compare groups. Secondary outcomes are variables that relate to wound healing, for example pain, use of painkillers, need for further follow-up, as well as other outcomes that may be related to the birth or healing process; urinary or anal incontinence, symptoms of prolapse, female body image and sexual problems.

Discussion:

Reducing the risk of wound dehiscence and/or infection would decrease the number of control visits, prevent the need for longer antibiotic treatment and possibly also decrease both short-term and long-term symptoms. This would be of great importance since the period after a delivery is a crucial time for the whole family.

Eligibility criteria: Inclusion Criteria:

* Danish speaking women above 18 years
* Second degree perineal tear and/or episiotomy
* Suturing of obstetric tear at Herlev Hospital

Exclusion Criteria:

* Allergies to the treatment.
* Women who end up with a cesarean-section, including those who have obstetric tears that require stitching or have had an episiotomy
* Women who receive antibiotics intra- or postpartum for other reasons.

Primary outcomes:
measure: Infection in the obstetric tear
timeFrame: Infection will be evaluated 1-2 weeks after the delivery.
measure: Wound dehiscence
timeFrame: Wound dehiscence will be evaluated 1-2 weeks after the delivery
Secondary outcomes:
measure: Clinically Relevant Wound Dehiscence
timeFrame: 1-2 weeks post partum
measure: Pain
timeFrame: 9-12 months after delivery.
measure: Sexual problems
timeFrame: 9-12 months after delivery.
measure: Body image
timeFrame: 9-12 months after delivery.
measure: Number of patients with prolapse
timeFrame: 9-12 months after delivery.
measure: Prolapse
timeFrame: 9-12 months after delivery.
measure: incontinence
timeFrame: 9-12 months after delivery.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Maternaty ward, Herlev Hospital
Study officials:
References: