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Actively Recruiting

Adnexal torsion occurs when an ovary twists around its blood supply, potentially causing tissue damage and serious complications if not treated quickly. This emergency condition affects about 3% of women of childbearing age and requires prompt surgery, ideally within 6 hours. Diagnosing adnexal torsion is challenging because symptoms like sudden pelvic pain are not specific, and current imaging tests, such as pelvic ultrasound with Doppler, have limited accuracy. No blood tests or definitive imaging exist, so diagnosis is often confirmed only during surgery, which leads to some unnecessary operations. The study is evaluating whether adding contrast-enhanced ultrasound using SonoVue®, a contrast agent injected intravenously, to the standard ultrasound improves diagnosis accuracy for suspected adnexal torsion. Participants are randomly assigned to either standard care with regular ultrasound or the experimental group receiving the contrast-enhanced ultrasound. The contrast evaluation involves a brief injection and about one minute of imaging acquisition. This trial is the second phase of a larger project and aims to reduce incorrect surgeries by improving diagnostic certainty. Women enrolled in the study will undergo clinical examination and ultrasound imaging as part of their diagnostic workup. Researchers will assess the effectiveness of this two-step diagnostic approach over a period of 38 months. They will monitor surgical outcomes to determine how often surgeries were correctly or incorrectly performed based on imaging results. Safety and health impacts are also tracked, with informed consent and social security coverage required for participation. The study focuses on female participants aged 18 and older who have a strong suspicion of adnexal torsion and are scheduled for surgery.

Age: 18Years +FEMALEPhase 3
6 locations
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Actively Recruiting

Researchers are investigating the effects of early versus late intervention for Twin Reversed Arterial Perfusion (TRAP) sequence in pregnant women. This open-label, randomized controlled trial aims to see if treating the condition earlier, between 12.0 and 14.0 weeks of pregnancy, improves outcomes compared to treatment done later, between 16.0 and 19.0 weeks. Women diagnosed with TRAP sequence between 11.6 and 13.6 weeks are randomly assigned to either early or late treatment groups, with analysis done by intention to treat and outcome assessments blinded to group assignment. The early intervention group receives ultrasound-guided intrafetal ablation using an 18 to 20 gauge needle within one week after randomization and before 14.0 weeks. The late intervention group receives either intrafetal ablation with a 17 to 20 gauge needle or fetoscopic laser coagulation of the cord or connecting vessels using specialized instruments, performed before 19.0 weeks. Procedures are done under local anesthesia or conscious sedation by experienced operators. Patients are usually discharged the same day or after one day. Participants will have follow-up scans about one week after intervention to check fetal health and exclude anemia, with detailed ultrasounds at 20 and 30 weeks to assess heart and brain anatomy. Some centers may also perform MRI scans around 30 weeks. Care during pregnancy, delivery, and after birth follows usual guidelines for single pregnancies and is decided by the referring physician. The main outcome measured is the number of babies surviving and born at or after 34 weeks.

Age: 18Years +FEMALEPhase 4
14 locations
Schiltigheim Clinical Trials | DecenTrialz