Ongoing Clinical Trials for Habitual Abortion
Currently, there are 2 ongoing clinical trials investigating new treatment approaches for women experiencing habitual abortion. These trials are taking place in Denmark and the Netherlands, testing medications that may help improve pregnancy outcomes for women who have suffered multiple pregnancy losses without a known cause.
Clinical trial locations
- Denmark
- Netherlands
Study on Hydroxychloroquine for Women with Recurrent Pregnancy Loss
This trial is investigating whether hydroxychloroquine, a medication commonly used to treat autoimmune conditions like lupus and rheumatoid arthritis, can help improve pregnancy outcomes for women who have experienced multiple pregnancy losses.
Who can participate:
Women aged 18 to 65 years who have experienced either four or more consecutive pregnancy losses before 22 weeks of pregnancy, or three or more consecutive losses with at least one occurring in the second trimester. All losses must be confirmed, and no known cause should have been identified.
Who cannot participate:
Men cannot participate in this study. Women outside the specified age range or those who are considered part of a vulnerable population are not eligible.
What the trial involves:
The study compares hydroxychloroquine with a placebo to determine if the medication can increase the live birth rate. Participants are randomly assigned to receive either the medication or placebo in tablet form. The trial follows each woman through her pregnancy journey, ending either after a pregnancy loss or six months after a live birth. The medication works by modulating the immune system and reducing inflammation, though its exact mechanism in preventing pregnancy loss is still being investigated.
The trial aims to enroll and follow 186 women to gather comprehensive data on the effectiveness of this treatment approach.
Study on Prednisolone for Women with Unexplained Recurrent Miscarriages
This trial, known as the PREMI trial, is exploring whether prednisolone, a type of steroid medication, can help women with unexplained recurrent miscarriages achieve successful pregnancies and live births.
Who can participate:
Women aged 18 to 39 years who have experienced two or more miscarriages without an identified cause after medical examination. Molar pregnancies (where a tumor forms in the uterus at the beginning of pregnancy) and ectopic pregnancies (where pregnancy occurs outside the uterus) are not counted toward this requirement.
Who cannot participate:
Men cannot participate. Women outside the specified age range or those whose miscarriages have a known cause are not eligible. Women considered part of a vulnerable population may also be excluded.
What the trial involves:
The study compares prednisolone with a placebo to assess whether taking this medication during early pregnancy can increase the chances of a successful live birth. Prednisolone is administered orally in tablet form. This medication works by suppressing the immune system and reducing inflammation, which may help maintain pregnancy. Participants are randomly assigned to receive either prednisolone or placebo, and regular monitoring occurs throughout pregnancy to track outcomes and gather data. The study is expected to continue until July 1, 2027, or until all participants complete their final visits and all necessary data is collected.
Summary
Both ongoing trials focus on women experiencing recurrent pregnancy loss without an identified cause, representing an important area of research for a challenging condition. The trials are taking place in different European countries, with Denmark hosting the hydroxychloroquine study and the Netherlands conducting the prednisolone trial.
Interestingly, both studies are testing medications that work by modulating the immune system and reducing inflammation, suggesting that immune factors may play a role in unexplained recurrent pregnancy loss. Hydroxychloroquine is primarily known for treating autoimmune diseases, while prednisolone is a corticosteroid with anti-inflammatory properties. Both medications are administered orally, making them relatively convenient treatment options if proven effective.
The age ranges differ between the two trials, with the hydroxychloroquine study accepting women up to 65 years and the prednisolone study limiting participation to women aged 18 to 39 years. The hydroxychloroquine trial requires a higher number of previous losses (three to four or more) compared to the prednisolone trial, which requires two or more miscarriages.
These trials represent hope for women who have experienced the emotional and physical challenges of repeated pregnancy loss, potentially offering new treatment pathways for a condition that currently has limited therapeutic options.