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New treatment option for Preeclampsia
Official title Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies
ClinicalTrials.gov ID: NCT06700044
What this study is testing
- What it's testing
- Preeclampsia (PE) is a complication during pregnancy characterized by hypertension, organ damage, and inflammation, without an effective treatment. The underlying mechanisms causing the disease also remain partly unknown.
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnant women ≥ 18 years old
- High risk of PE (≥ 1 high-risk factor, or ≥3 moderate risk factors according to the Swedish Society of Obstetrics and Gynecology (SFOG) 2019...
- High risk factors are:
- Auto-immune diseases such as SLE or anti-phospholipid syndrome
- Previous preeclampsia or eclampsia
You likely can't join if
- Enrollment in another clinical study
- Use of other probiotic supplements in the last 2 weeks before baseline, or during the course of the study
- Use of antibiotics in the last 6 weeks
- Current treatment with metformin, progesterone, or regular medical treatment which may impact study aim (e.g. laxatives)
- Immunosuppression
- Diabetes mellitus (type I and type II)
See the full eligibility criteria
- Pregnant women ≥ 18 years old
- High risk of PE (≥ 1 high-risk factor, or ≥3 moderate risk factors according to the Swedish Society of Obstetrics and Gynecology (SFOG) 2019 guidelines); or low risk of PE (no high-risk factors, or \<3 moderate risk...
- High risk factors are:
- Auto-immune diseases such as SLE or anti-phospholipid syndrome
- Previous preeclampsia or eclampsia
- Previous hypertension of pregnancy with preterm birth before gestational week 34, growth restriction, intrauterine fetal death or ablatio
- Type 1 or 2 diabetes
- Duplex (or triplex) pregnancy
- Kidney disease
- Chronic hypertension
- IVF with egg donation
- Moderate risk factors are:
- Nulliparity
- Heredity for preeclampsia (at least one of mother, maternal grandmother, or sister)
- BMI\>30
- Age\>40
- Pregnancy interval \>10 years
- Systolic blood pressure \>130 mmHg or diastolic blood pressure \> 80 mmHg at admission in antenatal maternity care
- African descent
- Verified obstructive sleep apnea
- Ability to give written informed consent
- Enrollment in another clinical study
- Use of other probiotic supplements in the last 2 weeks before baseline, or during the course of the study
- Use of antibiotics in the last 6 weeks
- Current treatment with metformin, progesterone, or regular medical treatment which may impact study aim (e.g. laxatives)
- Immunosuppression
- Diabetes mellitus (type I and type II)
- Inflammatory bowel disease
- Celiac disease
- Bad obstetric history
- Other serious conditions that might affect gut flora or capability of the subject to participate
- Language difficulties or difficulties understanding informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lund, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.