Clinical Research Directory

U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.

This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery. The U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.

Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery

This prospective observational cohort study investigates whether pre-anesthetic pupillary light reflex (PLR) parameters can predict the risk of hypotension following spinal anesthesia in women undergoing elective cesarean section. Spinal anesthesia-induced hypotension is common, with reported incidence rates of 50-90%, and current predictors such as baseline blood pressure and BMI have limited accuracy. PLR, a sensitive marker of autonomic nervous system balance, may offer a simple, objective, and non-invasive tool for identifying patients at higher risk. The study evaluates pupillary reaction latency and other PLR parameters and correlates them with post-spinal blood pressure changes to determine their predictive value.

BUprenorphine Versus Morphine for Postcesarean Analgesia (BUMP)

In this study the researchers are randomizing pregnant patients coming for elective cesarean delivery to receive either intrathecal buprenorphine or morphine for their analgesia.

Tranexamic Acid for Reducing Blood Loss in High-Risk Cesarean Delivery

This randomized study evaluated whether prophylactic tranexamic acid (TXA) reduces perioperative blood loss in women at increased risk of postpartum hemorrhage undergoing elective cesarean delivery. Women aged 18-45 years with at least one risk factor for postpartum hemorrhage were included. The anesthesia technique, spinal or general anesthesia, was selected before randomization based on clinical considerations and patient preference. Within each anesthesia group, participants were randomized to receive either 1 g intravenous TXA after umbilical cord clamping or no TXA. The main outcome was estimated blood loss calculated from perioperative hematocrit values. Other outcomes included postpartum hemorrhage, blood transfusion, changes in hemoglobin and hematocrit, need for additional uterotonic medications, adverse events, and thromboembolic events during follow-up.

TAP Block Versus ESP Block in Patients Undergoing Elective Cesarean Section: a Randomized Controlled Trial

This study is comparing two types of pain relief techniques-TAP block and ESP block-for women having an elective cesarean section. Both techniques involve injecting local anesthetic under ultrasound guidance to numb nerves and reduce pain after surgery. The TAP block mainly relieves pain in the abdominal wall, while the ESP block may reduce both abdominal wall and deeper, organ-related pain. The main goal is to see if there's a difference in pain at rest six hours after surgery. The study will also look at pain at later time points, the amount of opioid medication needed, how quickly women can walk, and when they start breastfeeding. A total of 156 women will be randomly assigned to receive one of the two blocks after standard spinal anesthesia. Pain will be measured using a simple 0-10 scale at 6, 12, and 24 hours, both at rest and during movement. The study follows strict ethical rules, ensures patient privacy, and all results-whether positive or negative-will be shared to help improve pain management after cesarean delivery.

Cesarean Anesthesia Blood Gas

This prospective observational cohort study will evaluate maternal and fetal blood gas parameters in women undergoing cesarean delivery under spinal or general anesthesia. Maternal venous blood samples will be obtained immediately before anesthesia induction, and umbilical arterial blood samples will be obtained after delivery and cord clamping. Blood gas parameters, including pH, pCO2, pO2, bicarbonate, base excess, lactate, and fetal carboxyhemoglobin levels, will be compared between the spinal and general anesthesia groups. The study will also evaluate maternal-fetal blood gas gradients, Apgar scores, neonatal intensive care requirements, and the relationship between smoking exposure and fetal carboxyhemoglobin levels.

Duration of Urinary Catheterization Following Cesarean Deliveries Under Neuraxial Anesthesia

In cesarean deliveries, urinary catheters are often used to help empty the bladder while patients have limited mobility. These catheters typically stay in during early recovery because certain pain medications can make it hard for patients to urinate. Recently, the Society of Obstetric Anesthesia and Perinatology (SOAP) recommended removing catheters within 6-12 hours after delivery to aid recovery. However, at BC Women's Hospital, a review found that catheters stayed in for an average of 19 to 19.4 hours, even when patients were mobile. Leaving catheters in too long can increase the risk of urinary tract infections (UTIs), pain, and urination issues, which can delay recovery and extend hospital stays. An internal review showed that factors like patient anxiety may affect when catheters are removed. Postpartum anxiety affects around 9.9% to 20.7% of new mothers in the first year and is an important factor in recovery after a cesarean delivery. The main goal of this study is to look at how long urinary catheters stay in patients who had a cesarean delivery under spinal or epidural anesthesia, and what the score is from a questionnaire used to measure anxiety called the State Trait Anxiety Inventory (STAI-S), to see if there is a link between them.

IC-CS Risk: Patient Outcomes

This study is looking at the impact of the implementation of a cesarean risk calculator on cesarean delivery and maternal morbidity rates.

Video Versus Verbal Preoperative Education in Elective Cesarean Delivery

This prospective randomized controlled trial aims to evaluate the effects of verbal and video-based preoperative education on anxiety levels and serum cortisol response in women scheduled for elective cesarean delivery under spinal anesthesia. Eligible participants will be randomly assigned to receive either standard verbal education or a standardized video-based educational intervention before surgery. Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI-S), and serum cortisol levels will be measured before and after the educational intervention. The primary objective is to compare the effectiveness of the two educational methods in reducing preoperative anxiety and physiological stress response.

Effect of Gestational Weight Gain on Spinal Anesthesia in Elective Cesarean Delivery

This prospective, observational, non-interventional study aims to evaluate the effect of gestational weight gain on regional anesthesia characteristics in pregnant women undergoing elective cesarean delivery. No additional intervention, medication, or procedure beyond routine clinical care will be performed. Participants will be classified according to gestational weight gain categories based on the Institute of Medicine (IOM) 2009 guidelines, and spinal anesthesia block characteristics, hemodynamic responses, and perioperative outcomes will be assessed.

Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin

A randomized trial of patients undergoing a term (≥37 weeks) induction of labor with a history of one prior Cesarean delivery, wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing Foley alone with concurrent Foley and Oxytocin use at the start of the induction. With this trial, the investigators aim to test our central hypothesis that concurrent Foley and Oxytocin will decrease time to delivery without increasing risks, compared to Foley alone.

Aromatherapy and Massage After Cesarean Delivery

Cesarean delivery is a common surgical procedure associated with postoperative pain, anxiety, and reduced maternal comfort during the early postpartum period. Non-pharmacological interventions such as aromatherapy and massage have been suggested as supportive approaches for improving maternal well-being; however, further evidence is needed regarding their effectiveness after cesarean delivery. This randomized controlled trial aims to evaluate the effects of aromatherapy inhalation and aromatherapy-assisted back massage on postoperative pain, anxiety, and postpartum comfort in women after cesarean delivery. Participants who meet the eligibility criteria will be randomly assigned to three groups: an aromatherapy inhalation group, an aromatherapy-assisted back massage group, and a placebo group receiving sterile water inhalation as a simulation. Interventions will be initiated after cesarean delivery, and outcomes will be assessed using the Visual Analog Scale for pain intensity, the State-Trait Anxiety Inventory for anxiety level, and the Postpartum Comfort Scale for comfort level. This study is expected to provide information about the potential contribution of complementary non-pharmacological interventions to maternal recovery after cesarean delivery.

Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies

Cesarean delivery is a commonly performed surgical procedure associated with worse postpartum pain when compared to vaginal birth. Uncontrolled postpartum pain is associated with increased neonatal and maternal risks. Multimodal non-opioid pain medications, including acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are the preferred first-line therapies. There is no standard practice, however, on best dosing schedules (ie staggered or different time v. simultaneous or same time). This protocol describes a randomized clinical trial aimed to determine whether staggered dosing of acetaminophen and NSAIDs in superior to simultaneous dosing in controlling post-cesarean pain.

Restrained vs Gripping String Techniques in Patients Undergoing Cesarean Delivery

This randomized controlled trial will compare two upper-extremity restraint techniques in patients undergoing elective cesarean delivery under neuraxial anesthesia. Participants will be randomly assigned to either standard forearm restraint placement or wrist-level gripping restraint placement. The study will evaluate whether the position of the restraint affects maternal anxiety during and after cesarean delivery. Anxiety will be measured at several perioperative time points using the State-Trait Anxiety Inventory (STAI-6). Secondary outcomes include pain, patient satisfaction, physiological measures such as heart rate and blood pressure, postpartum distress and mood, and restraint-related safety events. The study aims to determine whether wrist-level gripping restraints may reduce anxiety and improve the patient experience compared with standard forearm restraints.

Comparison of Non-Invasive Mean Arterial Blood Pressure Measurements at the Arm and Ankle During Elective Cesarean Delivery.

This observational study aims to compare mean arterial pressure measurements obtained using an ankle blood pressure cuff with those obtained using a standard upper-arm cuff in pregnant individuals undergoing elective cesarean delivery under spinal anesthesia. The primary objective is to determine the level of agreement between the two measurement sites.The main question\[s\] it aims to answer \[is/are\]: Demonstrate that the mean arterial pressure is similar between arm and ankle with the blood pressure cuff Every participant will be their own control. (Measurements will be taken at both sites on every participant)

Dexamethasone for Post-operative Pain After Cesarean Delivery Under Neuraxial Anesthesia.

After surgery pain in women who have had a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Insufficient pain relief can lead to longer hospitalization and long term pain, which can result in long term use of pain medication. A classic method to alleviate pain after cesarean delivery is by injecting morphine into the spinal fluid, in the women's back, in addition to prescribing morphine by mouth as needed after the surgery. However, the negative effects associated with morphine and morphine-like drugs, limit the doses used, their pain relief capacity, and can negatively affect the after surgical experience of women. An approach which uses pain relief that acts on different pain pathways to treat after surgery pain helps limit the negative effects of different drugs. The potential benefit of dexamethasone as pain relief in women who have had a cesarean delivery is all the more interesting because of its minimal negative effects compared to morphine-like drugs. Its low cost, its effectiveness to prevent nausea, and its impact on the general condition of patients make dexamethasone even more attractive.

A RCT of Labor Induction at 39 Weeks in Low - Risk Women in China

The investigators are committed to identifying the optimal timing of delivery for low-risk pregnancies. While current guidelines typically recommend induction at 41 weeks, emerging evidence suggests that elective induction at 39 weeks may lead to improved maternal and neonatal outcomes. The U.S.-based ARRIVE trial demonstrated that induction at 39 weeks significantly reduced cesarean delivery rates compared to expectant management, and a similar randomized controlled trial (French-ARRIVE) is ongoing in France. However, population-specific evidence for the Chinese population remains lacking. This study is designed to establish a prospective cohort of low-risk pregnant women in China, comparing the effects of induction at 39 weeks, induction at 41 weeks, and expectant management on cesarean section rates and other maternal and neonatal outcomes. In addition, multi-omics technologies will be employed to analyze cord blood samples-including metabolomics and proteomics-to identify early biomarkers potentially associated with long-term child health. The study will begin with a pilot phase to assess feasibility and inform operational strategies for large-scale implementation. The ultimate goal of this project is to generate evidence tailored to the Chinese population to support more individualized decision-making, improve clinical outcomes, and enhance maternal and neonatal safety.

An Observational Study Measuring in a Non-invasive Approach the Nociception Level Index and Its Association With Pain and Anxieiy Perception Evaluated by Questionnaires, in Awake Women During Elective Cesarean Delivery Under Spinal Anesthesiaanxiety

The Nociception Level (NOL) Index is a multiparametric, non-invasive monitor that objectively assesses nociception by integrating several autonomic physiological signals. Although the NOL Index has been extensively validated during general anesthesia, its performance in awake patients undergoing regional anesthesia remains poorly understood. During cesarean delivery (CD) under spinal anesthesia, autonomic responses may be influenced not only by nociceptive stimulation but also by anxiety, uterine contractions, hemodynamic changes, uterotonic medications, and other non-nociceptive factors. Understanding the relative contribution of these factors is essential before the NOL Index can be reliably applied in awake surgical patients. This prospective observational study aims to characterize the behavior of the NOL Index throughout elective CD performed under spinal anesthesia and to evaluate its relationship with subjective pain intensity, anxiety, uterine activity, perioperative autonomic responses, and routine physiological variables. Approximately 100 women undergoing elective CD under spinal anesthesia will be enrolled at Carmel Medical Center. Continuous NOL monitoring using the PMD-200 system will be performed from before spinal anesthesia until the early postoperative period. Subjective pain (Visual Analog Scale), anxiety (Visual Analog Scale for Anxiety), uterine activity, hemodynamic variables, perioperative medications, and predefined surgical events will be prospectively recorded and synchronized with continuous NOL measurements. Potential confounding factors, including vasopressor administration, uterotonic drugs, nausea, shivering, patient movement, and supplemental analgesia, will also be documented. This study will provide one of the first comprehensive evaluations of continuous NOL monitoring during CD under spinal anesthesia. The results are expected to improve the understanding of objective nociception monitoring in awake patients, clarify the influence of non-nociceptive autonomic activation on the NOL Index, and help define the clinical role and limitations of NOL monitoring during regional anesthesia, and may contribute to the future development of objective pain assessment strategies in obstetric anesthesia and other clinical settings involving awake patients.

Topical Tranexamic Acid to Reduce Blood Loss During Cesarean Delivery

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.

Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control

we aim to compare the analgesic efficacy of two intravenous ketorolac dosing regimens as part of a multimodal analgesic protocol that includes local wound infiltration for postoperative pain management after elective cesarean delivery.

The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry

The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery.

Dose-to-block Level Relation in Single Shot Spinal Anesthesia for Cesarean Section.

The study is designed to support or deny relation between the dose of hyperbaric bupivacaine given intrathecally and extent of spinal block level. There is ongoing debate whether anesthetists should adjust the dose in the range of conventional doses in order to achieve appropriate coverage of anesthesia which would be suitable for cesarean section. Two strategies are predominantly used: low dose strategy, which is focused on safety, and conventional dose approach, which is more effective in terms of success of anesthesia, with markedly higher rate of spinal block - related complications. It is hypothesized that there may be no relation between block level and the dose if conventional doses are used. For that purpose anesthetic charts of cesarean sections will be reviewed to gather information on the doses of anesthetic used and the level of spinal block they produced.

Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section

This study is designed to assess possible relation between the anthropometric data of pregnant women at term, as well as their babies, and the maximal level of sensory blockade following spinal anesthesia for cesarean section. The debate regarding this relation is ongoing. Although there is some relevant data in favor of both lack and the presence of significant relation between these variables, it is still not clear whether the same dose of local anesthetic is similarly effective, regardless of parturient's and fetal size.

Intrathecal Morphine vs Transversalis Fascia Plane Block After Cesarean Delivery

This prospective single-center study compares intrathecal morphine and ultrasound-guided bilateral transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean delivery under spinal anesthesia. The primary outcome is the number of parturients requiring rescue analgesia within the first 24 hours postoperatively. The secondary outcomes include postoperative pain scores, rescue analgesia requirement, nausea/vomiting, pruritus, and obstetric quality of recovery (ObsQoR-11).