Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05830162
Status:
RECRUITING
Last Update Posted:
2023-04-28
First Post:
2023-03-29
Brief Title:
Oral Antibiotics After Obstetric Perineal Tear
Sponsor:
Hanna Jangö
Organization:
Herlev Hospital
Study Overview
Official Title:
Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAIR
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 andor 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 andor 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 11 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 andor 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 andor 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 andor 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
Obstetric tear occurs in more than 90 of nulliparous women and up to 25 subsequently experience wound dehiscence andor 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 11 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 andor 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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None