Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear - a double-blinded placebo controlled randomized trail

This research is investigating if taking a short course of antibiotics can help prevent infections and problems with wound healing after women experience a tear in the area between the vagina and anus during childbirth. The study will compare an antibiotic (Bioclavid) with a placebo (a dummy pill that looks the same but contains no medicine). Doctors want to find out how many women develop an infection or have their wound open up again. They will also check for other issues like pain, bladder or bowel problems, and sexual difficulties after one week and one year. This information will help improve care for women after childbirth.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Herlev Hospital

Enrolment target

442

Start

02 Feb 2023

Obstetric perineal ruptur

What is this study about?

When a woman gives birth, sometimes the skin and muscle in the area between the vagina and anus (called the perineum) can tear. Doctors often stitch these tears up, but sometimes they can get infected or the stitches can open up again. This can be painful and lead to other problems.

This study wants to find out if giving women a short course of antibiotics by mouth after a childbirth tear can help prevent these infections and healing problems. They are comparing the antibiotic with a 'placebo' – this is a pill that looks exactly like the antibiotic but doesn't contain any active medicine. This is done so researchers can fairly compare how well the antibiotic works.

By taking part, you would help doctors understand the best way to help women recover after childbirth tears. They will be looking at how many women get an infection or have their wound open up in the days and weeks after birth. They will also be checking for other issues like discomfort, problems with going to the toilet, or discomfort during sex, both in the short term and up to a year later. Your involvement could help improve care for many women in the future.

Key takeaways

New study looking at antibiotics for childbirth tears.
Compares antibiotics with a dummy pill (placebo).
Aims to prevent infections and help wounds heal.
Checks for pain, continence, and sexual health up to a year.
If you are 18+ and had a tear, you might be able to join.

Who may be eligible?

This study is looking for women who are at least 18 years old.

You might be able to join if you have recently experienced a tear in your perineum during childbirth that required stitches.

Further checks will be done by the study team to make sure it's safe and right for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Have you recently experienced a perineal tear during childbirth?
Did your tear require stitches?
Are you female?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to take either the study antibiotic or a placebo pill for a short period after you've had your baby. You wouldn't know which one you are taking. You would also have some follow-up appointments or questionnaires. These would involve checking how your wound is healing, and asking about any pain, bladder or bowel problems, or issues you might have with sex. These checks would happen about one week after birth and then again after one year. The total duration of your participation would be for one year, although the main active part (taking medicine) is only for a short time after birth.

Potential risks and benefits

Potential benefits of taking part could include helping to improve future care for women after childbirth tears. You might also find that the specific support and monitoring you receive during the study is helpful. However, like all medicines, the antibiotic has potential side effects, and some people can experience issues with placebos too. Taking part means you might be taking a medicine that doesn't work for you, or one that has side effects. There might also be a small risk of discomfort from the assessments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Denmark

Common questions

What is a perineal tear?

A perineal tear is when the skin and muscles between the vagina and anus tear during childbirth. Doctors often stitch these tears.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers compare the real medicine's effects.

Why is this study 'double-blinded'?

This means neither you nor your study doctor will know if you are taking the antibiotic or the placebo. This helps make the study as fair and unbiased as possible.

What are the possible side effects of the antibiotic?

The study team will explain all known potential side effects of the antibiotic (Bioclavid) to you in detail before you decide to take part.

How long will I be involved in the study?

Your involvement in the study will last for about one year, with checks scheduled around one week and one year after giving birth.