Clinical Research Directory

Predictors of Severe Postoperative Pain Within 24 Hours After Elective Cesarean Delivery Under Spinal Anesthesia

This prospective observational study aims to identify predictors of severe postoperative pain during the first 24 hours after elective cesarean delivery under spinal anesthesia. Preoperative, intraoperative, and postoperative factors will be evaluated to determine their association with severe postoperative pain.

Effect of Video-Based Versus Verbal Preoperative Information on Anxiety and Cortisol Levels in Elective Cesarean Section

Preoperative anxiety is a common problem in patients undergoing elective cesarean section and may negatively affect perioperative outcomes through activation of the stress response, including increased cortisol levels. Effective preoperative information is considered a key non-pharmacological strategy to reduce anxiety; however, the optimal method of information delivery remains unclear. This prospective randomized controlled trial aims to compare the effects of video-based versus verbal preoperative information on anxiety levels and serum cortisol response in patients scheduled for elective cesarean delivery under spinal anesthesia. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), and serum cortisol levels will be measured before and after the intervention. The findings of this study are expected to provide evidence for improving patient-centered preoperative education strategies in obstetric anesthesia."

Effect of Oxytocin Bolus Versus Slow Infusion on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia

This study compares two standard ways of giving oxytocin (a medicine that helps the uterus contract) after the baby is born during a planned caesarean section performed under spinal anaesthesia. One group of women will receive oxytocin as a quick injection into the vein. The other group will receive the same dose of oxytocin as a slow infusion over 15 minutes. The researchers want to find out which method causes less drop in blood pressure and other heart-related changes, while still providing good contraction of the uterus and preventing excessive bleeding.

The Impact of Fasting Duration on Quality of Recovery After Cesarean Section

This study will evaluate the effect of fasting duration and elective c-section start time on the overall quality of recovery. Patients will be seen 24 hours after surgery to answer 11 questions on their overall recovery after surgery. Several factors will be tracked to determine their effect on recovery, with the primary variable of interesting

Post-operative Emesis and Pain Outcomes After Cesarean Delivery

Approximately 20% women who undergo cesarean delivery would suffer from severe post-operative pain, which may further increase their risks from developing postpartum depression. Predictive factors such as pre-operative pain, age and anxiety could significantly contribute to post-operative nausea and vomiting (PONV) and pain in general surgery, however little information is available with regards to cesarean delivery. The investigators would investigate the risk factors of causing post-operative emesis after cesarean delivery, and to reaffirm that there is a positive correlation between pain on local anesthetic injection, presence of mechanical temporal summation (MTS) and post-Cesarean pain scores.

Abdominopelvic Fascial Release for Post-Cesarean Menstrual Pain and Scar Mobility

The goal of this randomized controlled clinical trial is to determine whether adding abdominopelvic fascial release to a standardized stretching exercise program is more effective than stretching exercises alone in reducing menstrual pain in women following cesarean section. The study will enroll women aged 20 to 35 years with moderate to severe dysmenorrhea after cesarean delivery. Researchers will compare the effects of abdominopelvic fascial release combined with stretching exercises with stretching exercises alone on menstrual pain and scar mobility. Participants will be randomly assigned to one of two treatment groups, undergo assessments before and after the intervention period, and receive the assigned treatment according to the study protocol.

Association Between Cesarean Scar Mobility and Menstrual Pain in Post-Cesarean Women

The aim of this observational cross-sectional study is to investigate the association between cesarean scar mobility and menstrual pain severity in women following cesarean section. The study will enroll women aged 20 to 35 years with a history of cesarean delivery who experience menstrual pain. Baseline assessments will be performed to evaluate cesarean scar mobility, menstrual pain severity, pressure pain threshold, and related clinical characteristics. The findings will help clarify whether reduced cesarean scar mobility is associated with greater menstrual pain severity and may provide evidence supporting the clinical assessment of cesarean scars in women with post-cesarean menstrual pain.

Development of a Risk Prediction Model for Post-Spinal Anesthesia Hypotension During Cesarean Delivery Using Heart Rate, Blood Pressure, Perfusion Index, ECG Waveforms, and SpO₂ Waveforms

Spinal anesthesia is the preferred anesthetic technique for patients undergoing cesarean section. Compared with general anesthesia, spinal anesthesia offers multiple advantages. However, a common adverse effect of this technique is hypotension following spinal anesthesia, which is induced by sympathetic blockade and has an incidence rate as high as 70%. Hypotension can lead to maternal nausea and vomiting, reduced fetal Apgar scores, and acidosis, exerting adverse effects on both the mother and the fetus. Furthermore, prolonged duration of hypotension may adversely impact the fetal neurological prognosis. Therefore, predicting which patients are at high risk for developing hypotension facilitates the implementation of preventive measures-such as the administration of vasoactive agents and intensified monitoring through frequent blood pressure measurements-to improve clinical outcomes in these high-risk patients. Patients undergoing cesarean section who met the inclusion criteria were prospectively observed. A standardized anesthesia protocol was uniformly applied to investigate the incidence of hypotension following spinal anesthesia. Based on dynamic changes in preoperative and intraoperative heart rate, blood pressure, perfusion index, and waveform characteristics of electrocardiography and pulse oximetry, a prognostic model was developed to predict the occurrence of hypotension after spinal anesthesia.

Enhanced Recovery Protocol After Cesarean Section

This study aims to evaluate the effectiveness of implementing the Enhanced Recovery After Cesarean (ERAC) protocol on maternal and neonatal outcomes. Research hypotheses To fulfill the aim of the study, the following research hypotheses are formulated: Hypothesis I: Women who receive the ERAC protocol experience faster recovery compared to those who receive routine hospital nursing care. Hypothesis II: Women who receive the ERAC protocol experience fewer maternal and neonatal complications than those who receive routine hospital nursing care.

Nociception Level Index Monitoring During Cesarean Section

This prospective randomized controlled trial evaluated the effect of nociception level (NOL) index-guided intraoperative analgesia on postoperative pain management in patients undergoing elective cesarean section under general anesthesia. Sixty patients were randomly assigned to either NOL-guided analgesia or standard intraoperative monitoring. The primary outcome was postoperative pain intensity assessed using the visual analog scale (VAS) during the first 24 hours after surgery. Secondary outcomes included postoperative opioid requirements and time to first breastfeeding. The study aimed to determine whether objective intraoperative nociception monitoring could improve postoperative analgesia and enhance early maternal recovery.

Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

This single-center randomized controlled trial evaluates whether donor-derived fecal microbiota transplantation (FMT) administered within 6 hours after birth can improve gut microbiota development and reduce the risk of immune-mediated and metabolic diseases in infants born by elective cesarean delivery. Newborns are randomized 1:1 to receive either donor-derived FMT or standard postnatal care. Participants are followed through 36 months of age with stool samples, questionnaires, growth assessments, and health data collection, with registry-based follow-up continuing until 10 years of age.

Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity

This randomized controlled trial aims to evaluate the efficacy of preoperative vaginal cleansing with 5% povidone-iodine in reducing postoperative infectious morbidity among women undergoing cesarean section. The primary outcomes include wound-related complications, while secondary outcomes include postoperative fever, endometritis, wound infection, and white blood cell count.

Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions

This study is evaluating whether Steri-Strips® provide additional benefits when used after cesarean section (C-section) surgery. Steri-Strips are adhesive strips that are commonly placed over a surgical incision to provide support while the wound heals. At our hospital, Steri-Strips are routinely used after C-sections in addition to standard wound closure techniques, although they are not considered part of the standard recommended closure method. Researchers want to determine whether adding Steri-Strips actually reduces wound complications such as infection, fluid collection under the skin, or reopening of the incision. Previous studies have shown mixed results, with some suggesting little difference in wound healing outcomes while others reported differences in scar appearance. Steri-Strips may also increase costs, add time to the surgery, and occasionally cause skin irritation or allergic reactions. Participants in this study will be randomly assigned to one of two groups. One group will receive standard cesarean wound closure with Steri-Strips, while the other group will receive standard wound closure without Steri-Strips. Researchers will compare wound healing, complications, patient outcomes, and costs between the two groups. The goal of this study is to determine whether Steri-Strips improve recovery after cesarean delivery and whether their routine use is beneficial and cost-effective. The findings may help guide future recommendations for cesarean wound care and improve outcomes for patients undergoing C-section delivery.

Ultrasound-guided Versus Landmark-based Spinal Anesthesia in Obese Parturients Undergoing Cesarean Section

Spinal anesthesia is the most commonly used anesthetic technique for cesarean section. However, in obese parturients, identification of the optimal puncture site using anatomical landmark palpation can be challenging because of altered anatomy. Preprocedural ultrasound has been proposed as a tool to improve localization of the puncture site and facilitate neuraxial access. This is a prospective comparative study included 100 obese parturients undergoing cesarean section under spinal anesthesia. Participants were allocated to one of two comparison groups according to the puncture site localization technique: a preprocedural ultrasound group and an anatomical landmark palpation group. The primary outcome is the first-attempt success rate, defined as successful cerebrospinal fluid return after the first needle insertion without needle redirection or a new skin puncture. Secondary outcomes include the number of puncture attempts, needle redirections, need for rescue interventions, incidence of paresthesia and vascular puncture during the procedure, and procedural times.

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section

This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).

Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine

The goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment).

Intrathecal Dexmedetomidine vs Epinephrine

Several studies have shown that adding dexmedetomidine or epinephrine to single-dose spinal analgesia preparations improves the length and/or speed of onset of the sensory block and post-operative pain management without increased negative side effects. To date, however, no study has compared adjunctive intrathecal dexmedetomidine to adjunctive intrathecal epinephrine in single-dose spinal analgesia. The purpose of this study is to determine if adjunctive intrathecal dexmedetomidine is non-inferior to adjunctive intrathecal epinephrine in providing better single-dose spinal analgesia during cesarean section.

Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term

Labor induction is a common medical technique. There is no consensus on which technique is better than the others. Misoprostol is an analogue of Prostaglandin E1 previously used off-label in labor induction. Its low cost, room-temperature storage, and diverse route options have made it an alternative to PGE2 in labor induction. As of 2018, oral misoprostol 25 μg tablet was licensed for labor induction. Very few studies have been performed on oral misoprostol 25 μg and none compared it with the PGE2s mostly used in induction on unfavorable cervix at term. The investigators compared the safety and the efficacy between the oral misoprostol 25 μg Angusta® used since 20/02/2020 and the vaginal dinoprostone previously used in gel or diffuser over two consecutive periods from 01/01/2019 to 19/02/2020 for the dinoprostone and from 20/02/2020 to 07/04/2021 for the misoprostol.

Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study

Some patients who undergo cesarean section under spinal or epidural anesthesia can experience severe pain. Some patients who experience this kind of pain can experience symptoms of post-traumatic stress disorder (PTSD) after pregnancy. Currently, the two main options for treating this pain are general anesthesia (full medically induced unconsciousness) and using intravenous medications to reduce the pain and decrease anxiety. The EAGLET-CS Pilot is a pilot randomized trial that will test the feasibility of comparing the impact of these two options for preventing PTSD in a rigorous way for those patients who experience pain during their cesarean section after the baby is out.

Skin-to-Skin Contact and Lavender Aromatherapy After Elective Cesarean: Effects on Cortisol and Early Breastfeeding

This single-center randomized controlled clinical trial will evaluate the effects of structured early postpartum mother-infant skin-to-skin contact, with or without maternal lavender aromatherapy, after elective cesarean section on maternal stress biomarkers and early breastfeeding outcomes. The study will enroll 150 term pregnant women scheduled for elective cesarean section under spinal anesthesia at Ataturk University Research Hospital. Participants will be randomized into three groups: routine postoperative care, structured skin-to-skin contact, and structured skin-to-skin contact combined with inhalational lavender aromatherapy. The primary outcome is the change in maternal salivary cortisol level from immediately after birth to 60 minutes postpartum. Secondary outcomes include maternal salivary IgA levels, state anxiety scores, postoperative pain and nausea, time to first analgesic requirement, early breastfeeding initiation and success, LATCH scores, neonatal axillary temperature, cumulative duration and continuity of skin-to-skin contact, maternal satisfaction, and the need for mother-infant separation within the first 2 hours postpartum.

Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone

During standard cesarean deliveries, there are two ways that obstetricians repair the incision on the uterus (hysterotomy after delivery of the baby. One method involves lifting the uterus out of its regular place in the abdomen to repair the incision (uterine exteriorization for repair). The second method involves leaving the uterus inside the abdomen to repair the uterus (in situ repair). Both of these methods are regularly used by obstetricians during cesarean deliveries, and it is not currently known if one has benefits over the other. Currently, surgeons use both methods, but lifting the uterus out of its place is slightly more common. In this study, participants will be randomly assigned to have one of these techniques performed during their surgery. Researchers will be investigating whether one technique or the other leads to better contraction of the uterus after delivery, less bleeding, less intra-operative nausea/vomiting, or a better patient experience than another.

Determining the Optimal Dose of Intrathecal Morphine for Post-Cesarean Analgesia

Using spinal or epidural anesthesia (known as neuraxial blocks) is the gold standard for pain control during childbirth, especially in cesarean sections (C-sections). However, many women experience moderate to severe pain after a C-section, which can affect both their physical and emotional well-being, and even impact their ability to care for their newborn. Unfortunately, this pain is often not treated effectively, which can lead to increased sensitivity to pain or even chronic postoperative pain. One effective way to manage this pain is by giving opioids directly into the spinal fluid (subarachnoid space). This method allows doctors to use much smaller doses than would be needed if the same medication were given through a vein, which also helps avoid many of the common side effects of opioids like respiratory depression, nausea, pruritus, and constipation. Common opioids used in this setting include fentanyl, sufentanil, and morphine. These drugs behave differently depending on their chemical properties. For example, drugs that are more fat-soluble work faster, while those that are less fat-soluble tend to last longer. Morphine, which is less fat-soluble than the others, provides strong and long-lasting pain relief. When injected spinally, its effect can last 18-24 hours, with the pain relief starting 1-2 hours after the injection. Its performance is comparable to that of epidural anesthesia or nerve blocks. Researchers have studied a wide range of spinal morphine doses (from 20 to 500 micrograms) to find the most effective and safest dose. Most of these studies are small or use set doses without clear reasoning. Recently, a method called sequential allocation has become popular for finding the best dose more accurately. About the Study This research aims to find the ideal dose of spinal morphine when it's given with a fixed amount of fentanyl and varying doses of ropivacaine (a local anesthetic) during spinal anesthesia for C-section in healthy full-term parturients. The goal is to find the dose that provides adequate analgesia (pain score under 3 out of 10) for at least 12 hours after surgery. This is a prospective, non-randomized, double-blind study. The study follows ethical standards and all participants sign an informed consent form. Two anesthesiologists are involved in each case: one handles the spinal injection and dose decision (based on the previous patient's response), while the other monitors the patient and collects the data without knowing the dose used. Anesthetic Technique Spinal anesthesia is done using standard procedures. A very fine needle (25 or 27 gauge) is used to inject a mixture of fentanyl (15 mcg), a variable dose of ropivacaine (based on somatometrics), and a variable dose of morphine (based on the algorithm). The mixture is injected slowly (1 ml every 10 seconds), with the needle facing toward the head. After surgery, all women receive additional pain medications like paracetamol and NSAIDs as part of a multimodal pain relief approach. How the Morphine Dose is Decided The dose of morphine changes based on whether the previous participant had effective pain relief. Pain relief is considered successful if the pain score stays at or below 3 (on a 0-10 scale) for at least 12 hours after the spinal injection. For the first woman in the study, the starting dose is chosen based on published research. Then: * If the previous participant had good pain control (NRS ≤3 for 12 hours), the dose for the next woman is reduced by 20 micrograms. * If pain control was poor (NRS \>3 within the first 12 hours), the dose is increased by 40 micrograms. This up-and-down adjustment continues for each new participant.

Intra-abdominal Pressure, Abdominal Circumference, and Spinal Block Level in Cesarean Section

Spinal anesthesia is commonly used for cesarean section and provides effective anesthesia with rapid onset. However, the spread of spinal anesthesia may vary among pregnant women due to physiological and anatomical changes during pregnancy. Increased intra-abdominal pressure and abdominal circumference may influence cerebrospinal fluid dynamics and affect the level of sensory block achieved after spinal anesthesia. This prospective observational study aims to evaluate the relationship between intra-abdominal pressure, abdominal circumference, and the maximum sensory block level following spinal anesthesia in pregnant women undergoing cesarean section. Intra-abdominal pressure and abdominal circumference will be measured before surgery, and sensory block levels and hemodynamic parameters will be assessed after spinal anesthesia. The findings of this study may help to better understand factors affecting spinal block spread in pregnant patients.

Effects of Music Therapy, Breathing Exercises, and Virtual Reality on Obstetric Recovery, Pain, and Gastrointestinal Symptoms After Cesarean Section

Cesarean section is a common surgical procedure performed to deliver a baby when vaginal birth may pose risks to the mother or infant. Although it is often life-saving, recovery after cesarean section is frequently associated with multiple physical and psychological challenges, including postoperative pain, delayed gastrointestinal function, reduced mobility, fatigue, and decreased overall well-being. These factors may negatively affect a woman's ability to care for her newborn, initiate breastfeeding, and adapt to the postpartum period. In recent years, there has been increasing interest in non-pharmacological interventions that can safely support postoperative recovery without causing additional side effects. Among these, music therapy, breathing exercises, and virtual reality applications have been identified as promising approaches. Music therapy may promote relaxation and reduce pain and anxiety through auditory stimulation and emotional regulation. Breathing exercises may enhance parasympathetic activity, improve oxygenation, reduce stress, and support gastrointestinal motility. Virtual reality applications, by providing immersive audiovisual experiences, may reduce pain perception, decrease anxiety, and improve overall comfort through distraction and relaxation mechanisms. Although these interventions have individually demonstrated beneficial effects in postoperative care, the existing literature is limited in directly comparing their relative effectiveness within the same study design. Furthermore, most studies have primarily focused on pain outcomes, while other important aspects of recovery, such as obstetric recovery quality and gastrointestinal symptoms, have received less attention. This randomized controlled trial aims to comparatively investigate the effects of music therapy, breathing exercises, and virtual reality application on obstetric recovery, pain, and gastrointestinal symptoms in women following cesarean section. Participants will be randomly assigned to one of three intervention groups or a control group receiving routine care. Standardized protocols will be applied for each intervention to ensure consistency. The primary outcomes of this study include obstetric recovery, pain intensity, and gastrointestinal symptoms. By evaluating these outcomes simultaneously, the study aims to provide a more comprehensive understanding of post-cesarean recovery. The findings of this study are expected to contribute to evidence-based clinical practice by identifying effective, safe, and feasible non-pharmacological interventions that can be integrated into routine post-cesarean care. Ultimately, this research may help improve maternal comfort, accelerate recovery, and enhance the overall postpartum experience for women undergoing cesarean section.