Clinical Research Directory

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.

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)

Post-Operative Cesarean Section Cosmesis

Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block

To assess the effect of intraoperative transversus abdominis plane (TAP) blocks on the amount of opioid pain medications expressed as morphine milliequivalents (MME) used postoperatively in patients who have undergone cesarean delivery (CD) in the setting of complex obstetric surgery (COS).

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.

Prophylactic Tranexamic Acid in Low-Risk Repeat Cesarean Delivery: A Randomized Controlled Trial

Postpartum hemorrhage remains a leading cause of maternal morbidity following cesarean delivery. Tranexamic acid (TXA) has been shown to reduce blood loss when used for the treatment of postpartum hemorrhage; however, its routine prophylactic use during cesarean delivery, particularly in low-risk women, remains controversial. Large randomized trials have demonstrated limited benefit on major maternal outcomes, and data regarding clinically meaningful blood loss reduction and neonatal safety are still inconclusive. This randomized controlled trial aims to evaluate the effect of prophylactic tranexamic acid administered after fetal delivery on perioperative blood loss in women undergoing low-risk repeat cesarean delivery. Secondary objectives include the assessment of neonatal outcomes to further evaluate the safety of routine TXA administration in this population. The results of this study are expected to provide evidence to inform clinical decision-making regarding the routine use of tranexamic acid in low-risk repeat cesarean deliveries, balancing potential maternal benefits against neonatal safety considerations.

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.

Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine

Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another group.

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.

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.

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.

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.

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.

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.

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.

Comparison of Intrathecal Bupivacaine With and Without Morphine for Post-operative Analgesia in Parturients Undergoing Elective Cesarean Section: A Randomized Controlled Trial

The goal of this clinical trial is to compare intrathecal bupivacaine with or without morphine for postoperative analgesia in patients undergoing elective cesarean section. The main questions it aims to answer are: Is intrathecal bupivacaine with morphine superior to intrathecal bupivacaine alone for postoperative analgesia for parturients undergoing cesarean section? What is the duration of analgesia in the two groups? Researchers will compare drug intrathecal bupivacaine with morphine to a iintrathecal bupivacaine alone to see if intrathecal morphine has benefits for psotoperative analgesia . Participants will: Get intrathecal bupivacaine with Morphine or intrathecal bupivacaine alone during spinal anesthesia for cesarean section. They will be followed up for NRS pain scores and side effects for 24 hours. Time to need of first rescue analgesic will be noted

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.

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.

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.

Frequency of Occurrence and Risk Factors of Postoperative Nausea and Vomiting During Elective C-section Under Spinal Anesthesia With Preventive Medication

The aim of this study is to learn about the incidence and risk factors of nausea and vomiting during planned caesarean section under spinal anesthesia. The main question it aims to answer is : What are the incidence and risks factors of postoperative nausea and vomiting (NV) during planned caesarean section under spinal anesthesia with administration of intrathecal morphine and multimodal antiemetic prophylaxis ? Patients who will be managed according to the standard protocol in use in the department will have to answer specific questions about NV in the post-interventional recovery room and on 2 further visits in the first 24 hours post-caesarean section.

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.

The Effectiveness of a Care Bundle to Prevent Postpartum Hemorrhage After Cesarean Delivery

Delays in the detection or inconsistent use of effective interventions of postpartum hemorrhage can result in complications or death. We designed a cluster-randomized trial to assess a multi-component strategy for the detection and treatment of postpartum hemorrhage after cesarean delivery.

The Effect of Intrathecal Morphine and Erector Spina Plan Block on Serum Cytokine Levels and Chronic Pain in Caesarean Section Surgery

Working Title The Effect of Intrathecal Morphine and Erector Spina Plan Block on Serum Cytokine Levels and Chronic Pain in Caesarean Section Surgery Study Description This study aims to evaluate the effects of intrathecal morphine added as an adjuvant to local anesthesia during spinal anesthesia and the erector spinae plane block applied at the end of cesarean surgery on postoperative serum cytokine levels, pain intensity, need for rescue analgesia, hospital anxiety and depression levels, quality of obstetric recovery, and the development of chronic postoperative pain. Study Type Study Design: Observational Model: Two parallel groups Time Perspective: Prospective Interventions Intervention Type: Drug and Block Procedure Details: In patients included in the study, intrathecal morphine is administered as an adjuvant to local anesthesia during spinal anesthesia first group. At the end of surgery, an erector spinae plane block is performed other group. Primary Outcome Measures Serum Cytokine Levels Time Frame: 0., 6. and 24. Hours Assessment Method: Serum biochemical analyses Pain Intensity and Need for Rescue Analgesia Time Frame: 2., 4., 6., 12. and 24. hours, assessed using the Numeric Rating Scale(NRS) Hospital Anxiety and Depression Levels Time Frame: Preoperative and at 24 hours postoperatively Assessment Method: Hospital Anxiety and Depression Scale (HADS) Quality of Obstetric Recovery Score Time Frame: At 24 hours postoperatively Chronic Postoperative Pain Development Time Frame: Evaluated at 4 months postoperatively Assessment Method: Short Form McGill Pain Questionnaire-2