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NCT ID: NCT06452498 Not yet recruiting - Pre-Eclampsia Clinical Trials

Preeclampsia Intervention Netherlands

PI-NL
Start date: August 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child. Preterm PE affects about 1 in 100 pregnant individuals in the Netherlands. Signs of preterm PE can be high blood pressure and protein in the urine in the second half of pregnancy (but before 32-34 weeks of pregnancy). Other symptoms can develop, such as problems with blood clotting and how well the blood cells, liver, lungs, and brain work. The disease can lead to serious complications for both the mother and child. The only way to cure preterm PE is to make sure the child is born, and many times, children have to be delivered (very) early (before 37 weeks). Children born (very) early can suffer from infections, breathing difficulties, and problems in their development. Metformin is a medicine used to treat high blood sugar during and outside of pregnancy. In a previous study in South Africa, women with preterm PE that used metformin were able to safely remain pregnant for an extra week. Similarly, the main goal of the Preeclampsia Intervention NetherLands (PI-NL) study is to see if patients with preterm PE in the Netherlands that use metformin can remain pregnant for a longer time than patients taking a placebo. A placebo is a look-a-like capsule that contains no active ingredients. Researchers, the treating medical team, and participants will not know which participant gets which treatment. In addition, all participants will receive the standard care that all preterm PE patients get.

NCT ID: NCT06074601 Active, not recruiting - Preterm Birth Clinical Trials

MIRACLE of LIFE Study

MoL
Start date: August 1, 2021
Phase:
Study type: Observational

The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?

NCT ID: NCT04725812 Terminated - Pregnancy Related Clinical Trials

Complement Regulation to Undo Systemic Harm in Preeclampsia

CRUSH
Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II, single arm, open-label study to determine if treatment with eculizumab prolongs pregnancy compared to historical controls in women with preeclampsia between 23-30 weeks gestation.

NCT ID: NCT02765906 Completed - Hypertension Clinical Trials

Comparing Different Methods of Patient Education on Preeclampsia

Start date: May 2016
Phase: N/A
Study type: Interventional

Preeclampsia is a life-threatening condition unique to pregnancy which occurs in 5-8% of all pregnancies. It contributes to a large proportion of maternal mortality worldwide and these deaths largely result from delayed diagnosis. A number of studies have shown that patient knowledge about preeclampsia is poor and that patient education can improve patient awareness. The investigators would like to find out what type of patient education is most effective. The investigators propose a three arm randomized controlled trial (RCT) where the first arm will receive a graphic card depicting signs and symptoms of preeclampsia, the second arm will watch an educational video on preeclampsia, and the third arm will have no visual form of patient education; they will be exposed only to the counseling they receive with their routine prenatal care. The card and video were both developed by the Preeclampsia Foundation and in a prior RCT the card was shown to be a useful educational intervention. This study would expand on this previous data by comparing the graphic card to an informational video available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant -woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an educational tool. Patients in the arm receiving the graphic card for educational intervention will be allowed to keep this card. Primiparous patients seen in the ambulatory prenatal clinic and Maternal Fetal Medicine (MFM) clinic will be enrolled at 18w0d-24w6d gestation. At the time of enrollment baseline preeclampsia knowledge, demographics, and patient anxiety before and after initial exposure to the educational interventions will be assessed. A follow up assessment of knowledge of preeclampsia will be obtained at 32-36 weeks gestation to measure retention of knowledge. Patient medical records will be reviewed for delivery outcomes which will be recorded and compared.