CompletedPhase 4

Oral Antibiotics After Obstetric Perineal Tear

Denmark442 participantsStarted 2023-03-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Infection in the obstetric tear

Timeframe: Infection will be evaluated 1-2 weeks after the delivery.

Wound dehiscence

Timeframe: Wound dehiscence will be evaluated 1-2 weeks after the delivery

Trial details

NCT IDNCT05830162

SponsorHanna Jangö

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-04

View on ClinicalTrials.gov More Obstetric Trauma trials