RecruitingPhase IIInterventional

A study to investigate a tailor-made device designed to insert an intrauterine contraceptive device (IUD) immediately after childbirth

This study is exploring a new way to fit an IUD (also known as a 'coil') right after a woman gives birth. An IUD is a small, T-shaped device placed inside the womb for contraception. Traditionally, fitting an IUD after birth, when the womb is still large, uses metal tongs. This study is testing a new plastic 'straw' device, specially made to reach the top of the womb at this time. Researchers want to find out if this new tool makes the IUD insertion process simpler for doctors and more comfortable for women. If successful, it could make it easier for women to choose an IUD for contraception soon after having a baby.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Accord (United Kingdom)

Enrolment target

120

Start

27 May 2026

Estimated completion

30 Nov 2026

Contraception

What is this study about?

This study is about making it easier for women to get an IUD (often called a 'coil') right after they've had a baby. An IUD is a very effective type of contraception, shaped like a small 'T', that a healthcare professional places inside your womb. There are different kinds, some release hormones and some use copper.

Normally, when an IUD is fitted, a slim plastic tube is used. However, after childbirth, your womb is much larger, and the usual plastic tube isn't long enough. So, currently, doctors often use special metal tongs to place the IUD. This study is trying out a new plastic tool, similar to a 'straw', which has been specially designed to be long enough to reach the top of the womb after birth. The idea is that this new tool might make the IUD insertion process simpler, quicker, and more comfortable for women compared to using metal tongs.

The main goal is to see if this new plastic tool works well. If it does, it could mean that more women can choose to have an IUD fitted soon after giving birth. This would offer a convenient and effective long-term contraception option during a busy time in their lives.

Key takeaways

This study tests a new plastic tool for fitting IUDs (coils) right after childbirth.
It aims to make IUD fitting easier and potentially more comfortable after birth.
Participation involves a few extra check-ups, including an ultrasound.
Risks are similar to IUD insertion at other times (e.g., infection, device movement).
Your involvement could help improve future contraception options for women.

Who may be eligible?

This study is looking for pregnant women who are at least 16 years old. You should be planning to have a natural vaginal birth and want to have an IUD (either hormonal or non-hormonal) fitted within 48 hours of giving birth.

It's important that you're considered a good candidate for an IUD in general (meaning there are no existing medical reasons why an IUD wouldn't be safe for you). You also need to be able to understand and speak English well enough to give your informed consent to take part.

You won't be able to join the study if you have certain womb issues like large growths (fibroids) or an unusual womb shape. Also, if you have certain health conditions that would make an IUD unsuitable, if you need a C-section, or if you have an infection at the time of birth, you wouldn't be able to participate.

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 16 years old or older?
Are you currently pregnant and planning a vaginal birth?
Do you want to have an IUD fitted within 48 hours after your baby is born?
Are you generally suitable for an IUD (no known medical reasons against it)?
Can you understand and speak English well enough for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a consent appointment (up to 30 minutes) during your pregnancy. You'll then be randomly chosen to either have your IUD fitted with the new plastic tool or using the standard metal tongs. Shortly after your baby is born (within 48 hours), a midwife or doctor will fit the IUD.

During the IUD fitting, you'll be asked to score any pain you feel just before and after on a chart, and complete a short satisfaction survey (about 5 minutes total). Then, about six weeks after your baby is born, you'll have an in-person follow-up appointment at a specialist clinic (up to 1 hour). This visit will include an ultrasound scan to check the IUD's position, a gentle examination to check its threads, and some questions about how you're feeling, feeding your baby, and when you started having sex again. The study ends with a phone call around 12 weeks after birth, where you'll answer similar questions (up to 20 minutes).

Potential risks and benefits

Taking part means you'll have your full IUD check-up with the research team at a specialist clinic, which includes an ultrasound scan, potentially saving you a separate trip to your GP. While there are no other direct benefits to you personally, your participation could help improve future healthcare for other women. When it comes to risks, whether the new plastic tool or metal tongs are used, the general risks of IUD insertion are similar to those if it were fitted at any other time. These include a small chance of infection (about 1 in 100), the IUD moving or coming out (about 1 in 20), pain, or changes to your bleeding pattern. A very small risk is the IUD pressing through the womb wall (1-2 in 1000). You are free to withdraw from the study at any time.

Locations (1)

NHS Lothian
Approximate
Edinburgh, Scotland

Common questions

What is an IUD?

An IUD, or 'coil', is a small, T-shaped contraceptive device placed inside the womb by a healthcare professional that helps prevent pregnancy for several years.

Why is a different method needed after childbirth?

After giving birth, your womb is larger than usual, so the standard tools normally used to fit an IUD aren't long enough. This study is testing a new tool designed for fitting IUDs at this time.

Will I know which tool was used?

You will be randomly assigned to either the new plastic tool or the standard metal tongs. This helps ensure fair results for the study.

Will I have more appointments if I join?

You will have a few extra appointments for the study's follow-ups, including an in-person check six weeks after birth and a phone call at 12 weeks. The 6-week check replaces your usual GP check-up.

Who is paying for this research?

This study is funded by the Chief Scientist Office and the Edinburgh Family Planning Trust in the UK.

How to find out more

Lauren Craig

POP-IN.trial@ed.ac.uk +44 (0)131 651 9977 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.