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Comparing hysteroscopic surgery to mifepristone and misoprostol treatment for early pregnancy loss in women under 10 weeks of pregnancy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves women who have experienced an early pregnancy loss, which means a miscarriage that happens before 10 weeks of pregnancy. When a pregnancy loss occurs, the tissue from the pregnancy needs to be removed from the womb. There are different ways to do this, and this study compares two of these methods. The first method is called hysteroscopic resection, which is a procedure where a thin tube with a camera is inserted through the vagina into the womb to remove the pregnancy tissue. The second method is medical management, which uses medications to help the body expel the pregnancy tissue naturally. The medications used in this study are mifepristone, which is taken by mouth, and misoprostol, which is placed in the vagina.

The purpose of this study is to compare these two treatment methods to see which one works better at completely removing the pregnancy tissue, and to look at any problems that might happen either soon after treatment or later on. The study will also look at whether women are able to get pregnant again after treatment and how satisfied they feel with their care. Women who take part will be randomly assigned to receive either the surgical procedure or the medication treatment. After the treatment, they will have follow-up visits that include an ultrasound scan, which uses sound waves to create pictures of the inside of the womb, and a diagnostic hysteroscopy, which is an examination of the womb using a thin camera.

During the follow-up period, which happens about one to two months after treatment, doctors will check whether all the pregnancy tissue has been removed or if any tissue remains in the womb. They will also look for any scarring inside the womb that might have formed after treatment. Women in the study will be asked to complete questionnaires about how they are feeling and their quality of life at different times after their treatment. The study will also collect information about any complications that occur within 30 days of treatment and will track whether women become pregnant again in the year following their participation in the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    After joining the study, you will be randomly assigned to one of two treatment groups. One group will receive hysteroscopic resection, which is a procedure where a thin telescope-like instrument is used to remove pregnancy tissue through the vagina. The other group will receive medical management, which involves taking medications to help the body expel the pregnancy tissue naturally.

    The assignment is done randomly, similar to flipping a coin, to ensure fair comparison between the two treatment methods.

  2. Step 2

    Treatment administration

    If you are assigned to the medical management group, you will receive two types of medications: mifepristone and misoprostol.

    Mifepristone is available as 200 mg tablets and is taken by mouth. Misoprostol is available as 200 microgram tablets and can be administered either by mouth or inserted into the vagina, depending on the specific treatment protocol.

    The exact dosage, timing, and method of administration will be determined by the treatment protocol assigned to you.

    If you are assigned to the hysteroscopic resection group, you will undergo a surgical procedure to remove the pregnancy tissue.

  3. Step 3

    Follow-up ultrasound and examination

    Approximately 1 to 2 months after your treatment, you will have a follow-up appointment that includes an ultrasound examination and a diagnostic hysteroscopy.

    The ultrasound uses sound waves to create images of your uterus. The diagnostic hysteroscopy involves inserting a thin viewing instrument through the vagina to examine the inside of the uterus directly.

    These examinations are performed to check whether all pregnancy tissue has been completely expelled and to look for any retained products of conception, which means tissue that remains in the uterus.

    The examinations will also check for intra-uterine adhesions, which are bands of scar tissue that can form inside the uterus.

  4. Step 4

    Quality of life assessments

    You will be asked to complete questionnaires about your well-being and quality of life at two time points: 1 month after your treatment and 3 months after your treatment.

    These questionnaires help assess how you are feeling and recovering after the treatment.

  5. Step 5

    Monitoring for complications

    Any complications that occur within 30 days after your treatment will be recorded and monitored.

    This monitoring period helps ensure your safety and tracks any issues that may arise following the treatment.

  6. Step 6

    Long-term follow-up

    You will be followed for up to one year after joining the study to track pregnancy rates and the time needed to conceive if you attempt pregnancy during this period.

    This information helps evaluate the impact of the different treatment methods on future reproductive outcomes.

Who can join the trial?

3 criteria

  • You must have experienced an early pregnancy loss, which means a miscarriage that occurred before 10 weeks of pregnancy
  • You must be between 18 and 50 years old
  • You must be willing and able to sign an informed consent form, which is a document that explains the study and confirms you agree to take part

Who cannot join the trial?

4 criteria

  • The patient is younger than 18 years old or older than 64 years old
  • The patient is male (this study is only for women)
  • The pregnancy loss occurred at 10 weeks of gestation or later (gestation means the length of pregnancy counted from the first day of the last menstrual period)
  • The patient has not experienced an early pregnancy loss (early pregnancy loss means losing a pregnancy before 10 weeks)
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Investigated drugs

Misoprostol is a medication used to help the body pass pregnancy tissue after an early miscarriage. It works by causing the uterus to contract and expel the tissue naturally, similar to a natural miscarriage process.

What is already known about the treatment

This clinical trial does not specify any particular medications by trade name in the provided data. The trial compares hysteroscopic resection (a surgical procedure) versus medical management as treatment approaches for early pregnancy loss, but no specific medication names are listed in the source information. Therefore, no medication descriptions can be provided in the requested format.

Investigated diseases

Early Pregnancy Loss – Early pregnancy loss, also known as early miscarriage, refers to the spontaneous loss of a pregnancy before 10 weeks of gestation. This condition occurs when the embryo stops developing and the pregnancy tissue is expelled from the uterus. Women may experience vaginal bleeding, cramping, and passing of tissue. The pregnancy hormone levels decline after the loss occurs. Sometimes the tissue does not expel completely on its own, requiring medical intervention. This condition can have emotional and physical impacts on women who experience it.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-520166-63-00Estimated enrolment152 patientsSponsorUZ Brussel

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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