NCT05830162

Oral Antibiotics After Obstetric Perineal Tear

Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Hanna Jangö · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstetric Trauma
• Infections
• Wound Dehiscence

Interventions

Type	Name	Description
DRUG	Placebo	We will evaluate how many women gets an infection and/or wound dehiscence after a second degree obstetric tear or episiotomy
DRUG	Bioclavid (Amoxicillin and Clavulanic acid)	We will evaluate how many women gets an infection and/or wound dehiscence after a second degree obstetric tear or episiotomy

Timeline

• Start date: 2023-03-21
• Primary completion: 2024-01-04
• Completion: 2024-12-09
• First posted: 2023-04-26
• Last updated: 2024-12-12

Locations

1 site across 1 country: Denmark