Clinical trials

We have developed a digital assistant based on GPT (Generative Pre-trained Transformer) technology, trained specifically to provide empathetic, medically accurate, and guideline-based responses in Hebrew, tailored to the clinical protocols used in our clinic. The goal of this interventional study is to learn about the feasibility, usability, and acceptability of a GPT-based digital assistant for patients undergoing medication abortion or treatment for missed abortion. The study aims to assess use of the digital assistant, patient-reported usability, usefulness and satisfaction, perceived support, comprehension of treatment instructions, and decisions about contacting medical staff. Participants already receiving standard care for medication abortion or missed abortion at the clinic will be offered access to the digital assistant immediately after enrollment. They may use the assistant freely at home throughout their treatment process and will complete baseline and follow-up surveys about their experience, emotional state, and any additional contacts with the clinic.

This randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Participants are randomized in a 1:1 ratio to receive either intravenous papaverine 80 mg in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo, administered one hour after initiation of oxytocin. The primary outcome is the interval from study infusion to delivery. Secondary outcomes include mode of delivery and maternal and neonatal outcomes.

Pregnancy and the postpartum period increase venous thromboembolism (VTE) risk. After cesarean section, low-molecular-weight heparin (LMWH; enoxaparin) is commonly used for short-term thromboprophylaxis, but it requires daily subcutaneous injections and can cause adverse effects. Direct oral anticoagulants (DOACs) such as rivaroxaban offer convenient once-daily oral dosing. In women who meet institutional criteria for short-term postpartum thromboprophylaxis until hospital discharge, we will compare the laboratory anticoagulant effect of rivaroxaban versus enoxaparin using thrombin generation parameters. This randomized, open-label trial will enroll women undergoing elective cesarean section who are indicated for in-hospital prophylaxis. Blood will be drawn on postoperative day 2 at trough (pre-dose) and peak (\~3 hours post-dose) to measure thrombin generation, anti-Xa activity and drug levels, and participants will complete the Anti-Clot Treatment Scale (ACTS) satisfaction questionnaire. Safety follow-up will occur by telephone at 2 days post-discharge and at 6 weeks postpartum.

This randomized controlled trial will compare two methods of providing preoperative counseling before elective cesarean delivery: counseling by an obstetrician-gynecologist and counseling delivered through an artificial intelligence (AI)-based system. The study aims to evaluate the effects of these counseling methods on patients' anxiety levels, understanding of medical information, and satisfaction with the counseling process. Women scheduled for elective cesarean delivery will be randomly assigned to receive either standard physician counseling or AI-based counseling containing the same medical information. Anxiety, knowledge, and satisfaction will be assessed using questionnaires before and after counseling.

The goal of this clinical trial is to learn whether applying topical tranexamic acid (TXA) directly to the uterine incision during cesarean delivery can reduce surgical bleeding compared to placebo. The study will include pregnant women aged 18-51 undergoing elective cesarean delivery at term (37 weeks or more). The main questions it aims to answer are: * Does topical TXA shorten uterine closure time? * Does topical TXA reduce the need for additional hemostatic sutures? Researchers will compare women receiving topical TXA to those receiving placebo (normal saline) to see if TXA reduces intraoperative bleeding and improves surgical outcomes. Participants will: * Be randomly assigned to receive either topical TXA or placebo during cesarean delivery. * Have standard surgery and postoperative care identical in both groups. * Provide routine clinical data, including hemoglobin levels and recovery outcomes, from their medical records.

This study evaluates the impact of incorporating home-ultrasound (home-US) devices into telemedicine care for patients with gestational diabetes mellitus (GDM). The study will compare satisfaction, clinical outcomes, and healthcare costs between standard high-risk pregnancy care and care augmented by home-US.

This study compares two methods for removing the fallopian tubes and ovaries during vaginal hysterectomy for pelvic organ prolapse. One method uses an energy-based surgical device called LigaSure Maryland, which seals blood vessels using electrical energy. The other method is the standard surgical approach, which involves clamping, cutting, and suturing the tissue. The purpose of the study is to determine whether the use of the LigaSure device is as safe as, or more effective than, the standard technique, in terms of procedure duration, blood loss, postoperative pain, length of hospital stay, and complication rates. Women who are scheduled to undergo vaginal hysterectomy for pelvic organ prolapse and for whom removal of the fallopian tubes and ovaries is recommended may participate in the study. Participants will be randomly assigned to one of two groups, receiving either the LigaSure technique or the standard surgical technique. The decision to perform removal of the fallopian tubes and ovaries will be made before surgery based on standard medical indications. Participants will not be informed which surgical technique is used during their operation. Surgical outcomes between the two groups will be compared to evaluate safety and effectiveness.

This interventional study evaluates whether video-based patient education regarding Trial of Labor After Cesarean (TOLAC) reduces maternal anxiety compared with standard verbal counseling. Pregnant women eligible for TOLAC will be randomized to receive either a structured educational video or routine verbal counseling. Maternal anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI).

This single-center randomized controlled trial evaluates whether a short informative video can reduce anxiety and pain before the first postpartum administration of low molecular weight heparin (LMWH, Clexane). Eligible women will be randomized to receive either standard explanation alone or standard explanation plus a short educational video. The primary outcome is anxiety level assessed via the State-Trait Anxiety Inventory (STAI). Secondary outcomes include pain, satisfaction, and treatment adherence.

This study evaluates the impact of an informative video about perineal tears on maternal anxiety during labor. Perineal trauma during childbirth, especially severe tears such as obstetric anal sphincter injuries (OASIS), is associated with significant physical and psychological consequences, including anxiety, shame, fear, and social isolation. Despite growing awareness, many women report inadequate knowledge and preparation regarding these outcomes before labor. This prospective, single-center, randomized controlled trial will be conducted at Edith Wolfson Medical Center in Holon, Israel. A total of 110 primiparous women admitted for induction or early labor will be recruited prior to the active phase of labor. Participants will be randomized into two groups in a 1:1 ratio. The intervention group will watch a 2-minute educational video explaining the types, implications, and prevention strategies related to perineal tears. The control group will receive standard care without video exposure. The primary objective is to assess change in maternal anxiety using the validated State-Trait Anxiety Inventory (STAI-S) questionnaire, measured at baseline and 2-24 hours postpartum. Secondary outcomes include satisfaction with the video (in the intervention group), rates of perineal tears, episiotomy, and OASIS. Data will be collected from the hospital's EMR system and patient-reported questionnaires, stored securely and coded. The study aims to determine whether increasing knowledge through a short educational intervention can reduce childbirth-related anxiety and improve the birth experience.

Chorioamnionitis, or intraamniotic infection, is a common condition affecting 2-5% of all term births. This condition poses well-recognized maternal and neonatal risks, and entails a series of clinical management decisions concerning both the mother and neonate. Therefore, timely detection and treatment of chorioamnionitis is of paramount importance. The occurrence of chorioamnionitis is associated with a higher risk of labor abnormalities, which increase the risk of cesarean delivery (CD) 3 to 4 fold. As recommended by current guidelines, treatment of suspected intraamniotic infection should include broad-spectrum antibiotics. In addition, the use of antipyretics is advocated. This is particularly important during the intrapartum period since fetal acidosis in the setting of fever has been associated with a marked increase in the incidence of neonatal encephalopathy. Maternal fever even in the absence of documented fetal acidosis is associated with adverse neonatal outcomes, particularly neonatal encephalopathy, though it is unclear to what extent the etiology of the fever rather than the fever itself is causative . Furthermore, treating intrapartum fever with antipyretics may also be helpful in reducing fetal tachycardia thereby avoiding the tendency to perform cesarean for a non-reassuring fetal status. Nevertheless, it remains understudied which is the most appropriate antipyretic agent in this regard, where both dipyrone and acetaminophen are safe alternatives . Antipyretic agent with a faster onset of action may be preferable in this setting.

The goal of this clinical trial is to evaluate the effect of routine activity versus rest on the risk of preterm delivery in pregnant women with a short cervix diagnosed between 24 and 34 weeks of gestation. The main questions it aims to answer are: Does routine activity influence the gestational age at delivery? How does routine activity affect secondary outcomes such as preterm labor, premature rupture of membranes, delivery mode, maternal anxiety, and satisfaction? Researchers will compare women instructed to maintain routine activity (control group) to women advised to practice maximal rest (intervention group) to see if physical activity impacts preterm birth outcomes. Participants will: Wear a smart band to monitor step counts over a two-week period. Be randomized into two groups: one encouraged to maintain routine activity and the other advised to follow strict rest protocols. Undergo regular follow-ups at a high-risk pregnancy clinic and have their data collected through hospital records and smart band tracking. This randomized controlled trial will assess gestational age at delivery as the primary outcome, along with secondary maternal and neonatal outcomes, providing insight into the role of physical activity in managing pregnancies complicated by a short cervix.

To determine whether watching a personalized video prior to medically indicated labor induction among term parturients reduces anxiety levels according to the STAI questionnaire, compared to a standard counselling.

Lubrication gels are widely used in numerous gynecologic procedures in order to ease the insertion of speculum and visualize the cervix. It was shown that applying lubricating gels significantly decreases patient pain during vaginal speculum examination. While many fertility specialists use lubrication gels to insert the speculum during embryo transfer (ET), others are strongly reluctant to use gels due to concern that they might have a detrimental effect on embryos and ET success. Similar concern was prevalent regarding the use of lubrication gel during Pap-smear for detection of cervical dysplasia. However, several studies have shown that the use of small amount of water-soluble gel does not change cervical cytology. Lubrication gels might have deleterious effect on sperm motility. However, there wasn't any study examining the effect of lubricant gel on ET success. The investigators hypothesize that using a lubrication gel will not reduce the live birth rate per transfer, but decrease patient pain during procedure.

The ReDUCE Trial is a multinational single-blinded randomized controlled trial in mild to moderate flare of Ulcerative colitis (UC) disease patients. The purpose of the study is to validate the clinical efficacy of the UCED (Ulcerative colitis Exclusion Diet) with partial enteral nutrition (PEN) using a novel formula. The investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.