Study on Immediate vs. Delayed Insertion of Levonorgestrel IUD for Women After Medical Abortion

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What is this study about?

This clinical trial is focused on studying the use of intrauterine contraception (IUC) following a medical abortion. The study aims to determine if inserting the IUC immediately after the abortion is more effective than waiting 2-4 weeks. The trial involves three types of IUCs: Mirena, Kyleena, and Jaydess, all of which contain the active substance levonorgestrel. These devices are small, T-shaped plastic systems placed inside the uterus to prevent pregnancy.

The study will follow participants for up to 12 months to observe how many women continue using the IUC as their method of contraception. Participants will be divided into two groups: one receiving the IUC immediately after the abortion and the other receiving it after a delay. Researchers will check in with participants at 3, 6, and 12 months to gather information on the use of IUC, any difficulties with insertion, pain levels, and any complications such as bleeding or infections. They will also record any pregnancies that occur during the study period.

The purpose of this study is to find out which timing for IUC insertion is more acceptable and effective for women after a medical abortion. The study will also look at how easy the insertion process is for healthcare providers and how women feel about the procedure. This information will help improve post-abortion care and provide better contraceptive options for women.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must be above 18 years old, eligible for a medical abortion, opting for post-abortion intrauterine contraception, and able and willing to comply with planned follow-up.

2 medical abortion procedure

The medical abortion procedure is conducted as per standard medical guidelines. This step is necessary before the insertion of intrauterine contraception.

3 insertion of intrauterine contraception

Participants are randomly assigned to one of two groups: immediate insertion or delayed insertion of intrauterine contraception (IUC).

Immediate insertion occurs right after the medical abortion, while delayed insertion is scheduled 2-4 weeks post-abortion.

The types of IUC used in the study include Mirena, Kyleena, and Jaydess, all of which are intrauterine delivery systems.

4 follow-up assessments

Follow-up assessments are conducted at 3, 6, and 12 months post-insertion. These assessments may be done via telephone or email.

The assessments evaluate the continued use of IUC, any discontinuation, ease of insertion, pain experienced during insertion, and any complications or adverse events.

5 final evaluation

At the end of the study period, the primary endpoint is assessed, which is the proportion of women using IUC as contraception at 6 months post-abortion.

Secondary endpoints include the acceptability of IUC, expulsion rates, and any pregnancies occurring during the follow-up period.

Who Can Join the Study?

Must be above 18 years old.
Must be eligible for medical abortion (able to have a medical procedure to end a pregnancy).
Must be opting for post abortion Intrauterine contraception (IUC) (choosing to use a device placed in the uterus to prevent pregnancy after an abortion).
Must be able and willing to comply with planned follow up (agree to attend scheduled check-ups and follow instructions).
Must be female.

Who Cannot Join the Study?

Women who are not within the age range specified for the study.
Women who are not part of the specified clinical trial group.
Women who are not considered part of the vulnerable population. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as those with limited access to healthcare or social support.
Men cannot participate in this study.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Region Dalarna	Falun	Sweden
Lund University Hospital	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Uupepbq Ufzoiowjfw Hqdgbglx	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	07.01.2020

Trial locations

Investigated drugs:

Levonorgestrel

Intrauterine Contraception (IUC) is a small device that is placed inside the uterus to prevent pregnancy. It is a long-term birth control method that can last for several years. The device works by releasing hormones or using copper to stop sperm from fertilizing an egg. In this clinical trial, researchers are studying whether inserting the IUC immediately after a medical abortion is more effective than waiting 2-4 weeks to insert it. The goal is to see how many women continue to use the IUC as their method of contraception six months after the abortion.

Post medical abortion contraception – This condition refers to the use of contraceptive methods following a medical abortion to prevent future unintended pregnancies. After a medical abortion, the body undergoes hormonal changes as it returns to its pre-pregnancy state. The timing of contraceptive initiation can influence its effectiveness and the woman’s comfort. Immediate insertion of intrauterine contraception (IUC) is one option, which can be compared to delayed insertion a few weeks later. The progression involves monitoring the use and effectiveness of the chosen contraceptive method over time. Factors such as ease of insertion, pain, bleeding, and expulsion rates are considered in evaluating the suitability of the contraceptive method.

Trial ID:

2024-517082-16-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Immediate vs. Delayed Insertion of Levonorgestrel IUD for Women After Medical Abortion

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?