All studies
AuthorisedTherapeutic confirmatory (Phase III)Interventional

Immediate versus delayed insertion of intrauterine contraception at the time of medical abortion- An open-label, randomized, multicenter study

This study is looking at the best time to fit an intrauterine contraceptive (IUC), also known as a coil, after a medical abortion. Researchers want to see if fitting the coil immediately after the abortion, or waiting a few weeks, makes a difference to how many women are still using it six months later. They are also checking how easy it is to fit the coil, how much pain women feel, and if there are any problems like the coil coming out or unexpected pregnancies. The aim is to find out which approach is better for women who choose this type of contraception.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Karolinska Institutet
Enrolment target
720
Start
09 Oct 2024

What is this study about?

When a woman has a medical abortion, she might want to start using contraception straight away to prevent another pregnancy. Intrauterine contraception, often called a coil (like Mirena, Kyleena, or Jaydess), is a very effective option. This study is trying to find out the best time to put one of these coils in after a medical abortion – should it be done right away during the same appointment, or should women wait a few weeks and have it fitted at a follow-up appointment?

The main thing the researchers want to learn is how many women in each group (those who had it fitted immediately and those who waited) are still using their coil six months after their abortion. This will help them understand which approach leads to more women successfully using this contraception long-term.

They will also be looking at other important details. For instance, they'll check how easy it is for healthcare staff to fit the coil, how much discomfort or pain women feel during the fitting, and if there are any unexpected pregnancies over the next year. They'll also find out if the coils stay in place or if any come out, and gather feedback from women about whether they would recommend the procedure to a friend. All these details will help doctors understand the benefits and challenges of each timing option, making it easier for women and their doctors to make informed choices.

Key takeaways

  • The study compares immediate vs. delayed coil fitting after medical abortion.
  • It aims to find out which timing results in more women using contraception successfully long-term.
  • Participation involves being randomly assigned to one of two groups.
  • You will have follow-up checks for up to 12 months.
  • Your feedback on pain and satisfaction is important for the study.
  • Your participation could help improve future care for other women.

Who may be eligible?

This study is open to women who are 18 years old or older. There is no upper age limit, meaning women of any age above 18 can potentially take part.

The study is specifically for women who are having a medical abortion and wish to use an intrauterine contraceptive (IUC) afterwards. If you are considering this type of contraception after a medical abortion, you might be a good candidate for this research.

Your doctor or nurse will be able to tell you if you meet all the specific requirements to join the study.

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.

  1. Are you 18 years old or older?
  2. Are you having a medical abortion?
  3. Are you considering using an intrauterine contraceptive (coil) afterwards?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups. One group would have their coil fitted immediately after their medical abortion, and the other group would have it fitted a few weeks later. You don't get to choose which group you are in; it's decided by chance, like flipping a coin.

Throughout the study, you would have follow-up appointments, which might be by phone or email, at 3, 6, and 12 months after your abortion. During these follow-ups, questions would be asked about whether you are still using your coil, if you've had any problems, or if you've become pregnant. You would also be asked about your pain levels during the coil fitting and whether you would recommend the procedure to a friend.

Potential risks and benefits

Taking part in this study could help future patients by providing valuable information about the best timing for coil insertion after an abortion, potentially making the process safer and more effective for others. For you, the potential benefits include receiving high-quality contraceptive care and close monitoring. As with any medical procedure, there are potential risks, such as discomfort during insertion, or the coil moving or coming out (expulsion). These risks are carefully monitored by the healthcare team. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is an IUC?

An IUC, or intrauterine contraceptive, is a small device fitted inside your womb to prevent pregnancy. It's often called a coil.

Will I get to choose when my coil is fitted?

No, if you join the study, you'll be randomly put into a group where the coil is fitted either immediately or at a later date. It's like drawing lots.

How long will the study follow me?

The study will follow your progress for up to 12 months, checking in with you at 3, 6, and 12 months after your abortion.

What if I experience pain during the fitting?

The study will record how much pain you feel during the fitting using a simple scale, so the researchers can understand the experience better for all women.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.