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54 active trials for Cesarean Section Complications

Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section. In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.

Start: February 2021

SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections

Our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. We also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to NPWT use. Additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the NPWT.

Start: May 2019

Vertical Splitting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury

Cesarean section is one of the oldest surgical interventions in the history of medicine.Many variations in cesarean section technique have been studied.The investigatory team are aiming to decrease blood loss during cesarean section by vertical splitting versus transverse cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.

Start: January 2021

Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery

The incidence of obesity parturient has been increasing worldwide. There was a report revealing one third of pregnant women in United state considered obesity. Obesity is associated with increased in maternal and neonatal complications. Also, there was an increasing in the rate of cesarean delivery. Anesthetic management of the obese parturient is differ from non-obese parturients. There were higher risk of difficult intubation, failed intubation, pulmonary aspiration and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient. The aim of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in Single University hospital, Bangkok, THAILAND.

Start: December 2020

The PartoMa Project: Enabling Best Post Possible Childbirth Care in Tanzania.

Introduction Childbirth care remains suboptimal in many low-resource settings, causing unacceptable maternal and perinatal mortality and morbidity. Realistic, context-tailored clinical support is called for to assist birth attendants in providing best possible evidence-based and respectful care. The PartoMa pilot study from Zanzibar suggested that co-created clinical practice guidelines and low-dose, high-frequency training were associated with care improvements and perinatal survival. In the present study we will modify, implement and evaluate this intervention in five urban, high-volume maternity units in Tanzania. Methods and Analysis The study design is based on a theory of change, and includes three main steps: I. A mixed-methods situational analysis will explore factors affecting care. Step II. Based on step I., the PartoMa guidelines and training will be contextually modified through discussions with birth attendants and postpartum women. III. The modified intervention will be implemented through a stepped-wedge cluster trial, with embedded qualitative and economic analyses. Women in active labour and their offspring will be followed until discharge to assess intra-hospital stillbirths, intra-facility neonatal deaths and caesarean sections without medical indications, and the incremental cost-effectiveness ratio will be measured. Central intermediate outputs include health providers' knowledge, barriers and facilitators to intervention use, and clinical performance.

Start: January 2021

Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Cesarean Section in Primigravida

The aim of the work is to compare the efficacy of preoperative IV tranexamic acid and rectal misoprostol in reducing blood loss in the elective cesarean section. Research question: In women undergoing elective cesarean section, is preoperative administration of IV tranexamic acid better than rectal misoprostol in reducing blood loss?

Start: December 2020

IV Ketorolac on Platelet Function Post-Cesarean Delivery

Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence and degree of platelet inhibition after NSAID exposure is less clear. The investigators plan to use Platelet Aggregometry and Thromboelastography (TEG) to evaluate the effect of ketorolac on platelets.

Start: January 2021

Cesarean Scar Defect (CSD); Prevalence, Risk Factors And Possible Associated Symptoms

The study aims to detect the incidence of Cesarean Scar Defect (CSD) in women undergoing CS in Women Health Hospital (WHH), assiut University, to identify risk factors for development of CSD and identify the possible gynaecological symptoms related to CSD.

Start: December 2020

The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level

The study aim is to examine the relationship between providing information to women prior to elective cesarean delivery and anxiety levels around surgery. the patients will be assigned into two groups - intervention and control. In the intervention group - the day before surgery the women will watch a pre-prepared video showing in detail the course of events around the operation. the level of anxiety, pain level and Intake of Analgesics will be compared between the two groups

Start: July 2020

Calcium Chloride for Prevention of Uterine Atony During Cesarean

In this pilot study, investigators will administer calcium chloride or placebo to pregnant women undergoing Cesarean delivery who have been identified as high risk for hemorrhage due to poor uterine muscle contraction, or atony. They will assess whether a single dose of calcium given immediately after the delivery of the fetus decreases the incidence of uterine atony and bleeding for the mother. The pharmacokinetics of calcium chloride in pregnant women will also be established. Data from this pilot study of 40 patients will be used to determine sample size and appropriateness of a larger randomized clinical trial.

Start: March 2019

Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins

Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy

Start: September 2020

Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section

To evaluate the efficacy of lidocaine patch applied around wound in reduction of postoperative pain and illus compared to intravenous lidocaine infusion and placebo after cesarean section.

Start: September 2020

Postoperative Dexamethasone on Post-Cesarean Pain

Investigating if giving post-operative dexamethasone to patients with a history of opioid use disorder on medication assisted treatment during pregnancy improves their pain scores and decreases their opioid use after cesarean section.

Start: July 2020

Traxi Panniculus Retractor for Cesarean Delivery

This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.

Start: October 2018

Spinal Anesthesia in Caesarean Section

Spinal anesthesia is a safe technique, widely used and tested in the gynecological field, so as to be considered the first choice technique in cesarean section, which allows to quickly obtain a valid sensor and motor block. Bupivacaine is one of the most widely used drug for obtaining spinal anesthesia in pregnant women undergoing caesarean section. Bupivacaine is a local anesthetic available as a racemic mixture of its two enantiomers, the R (+)- dextrobupivacaine and the S (-) - levobupivacaine, whose clinical use is widely validated. Racemic bupivacaine is available as a simple or hyperbaric solution, the latter being the most commonly used for spinal anesthesia. Levobupivacaine, which is the pure levorotatory enantiomer of racemic bupivacaine, is a slightly hypobaric solution compared to liquor and has shown less heart and nerve toxicity, probably due to its ability to bind proteins more rapidly, and a greater selectivity towards the sensory component compared to Bupivacaine, presents action and effects better predictable. Its baricity would also offer the advantage of providing a less sensitive block to the position. Hypotension is one of the most common complications of spinal anesthesia and is particularly relevant in caesarean section because, in addition to the adverse effects on the parturient, it can have repercussions on the fetus through a reduction of placental perfusion. Some studies have showed a similar incidence of hypotension in patients treated with bupivacaine compared to those treated with levobupivacaine, while others assert an equivalence between the two drugs. In most studies, however, a significantly lower incidence of hypotension and a greater hemodynamic stability were reported in pregnant patients undergoing spinal anesthesia by caesarean section with levobupivacaine. Being both hyperbaric bupivacaine and levobupivacaine routinely used at the "G. Rodolico" Universitary Hospital of Catania for the spinal anesthesia of pregnant women undergoing caesarean section and being their use decided exclusively at discretion of the treating anesthesiologist, in the light of the discrepant data in the literature about the incidence of hypotension with the two drugs, the main objective of this observational study is to evaluate the hemodynamic effects mediated by levobupivacaine on pregnant women subjected to elective cesarean section and to compare them with those mediated by hyperbaric bupivacaine in an historical court of pregnant women subjected to caesarean section in the period between April 2017 and April 2018. The hemodynamic parameters will be monitored in real time with a non-invasive hemodynamic monitoring system (EV1000® platform + Clearsight® system - Edwards LifeSciences), routinely used in the "G. Rodolico" Universitary Hospital of Catania, allowing to obtain greater accuracy and veracity of the results compared to previous studies conducted on such anesthetics.

Start: June 2018

Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control

Objective The objective of this study is to test the hypothesis that instillation of intra-abdominal chloroprocaine during cesarean deliveries is associated with decreased postoperative pain and nausea compared to placebo, without increasing intraoperative and postoperative complications. Methods The investigators plan to randomize about 150 women undergoing primary and repeat cesarean deliveries to intra-abdominal chloroprocaine versus placebo prior to abdominal closure. Women will be excluded if they have ascertained or presumptive hypersensitivity to the ester type and major anesthetics; if they have chronic pelvic pain or if they refuse to participate in the study. The investigators' primary outcome measure will be postoperative pain as measured by visual analogue scale (VAS) at 1 hour after skin closure. Secondary outcomes will include objective pain as measured by VAS at 2, 6, 24 and 48 hours at rest and during mobilization, adverse effects of chloroprocaine (gastrointestinal side effects, pruritus), concomitant analgesic requirement, hospital readmissions and length of hospital stay. Analysis will follow the intention-to-treat principle. The investigators will also be studying the concentration/effect (PKPD) relationship of chloroprocaine use for pain control in the postpartum period. The time courses of the plasma concentrations of chloroprocaine will be analyzed with mixed effects pharmacokinetic-pharmacodynamic (PKPD).

Start: June 2021

IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

The aim of this study is to evaluate the effectiveness of intramuscular (IM) 0.5 mg neostigmine for accelerating bladder emptying and preventing postoperative urine retention (POUR) after cesarean section (CS) performed under spinal anesthesia.

Start: May 2020

Management of Prelabor Rupture of the Membranes at Term

Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).

Start: May 2020

TENS and Opioid Use After Cesarean Delivery

We propose to explore the effects of Transcutaneous Electrical Nerve Stimulation (TENS) therapy in the pain management of postpartum women. A. Objectives To determine if the addition of TENS therapy to the pain management of women post-cesarean section leads to less opioid medication use. To evaluate the efficacy of TENS therapy as a means of alternative pain relief for women post-cesarean section with a history of opioid use. B. Hypotheses / Research Question(s) We hypothesize that patients that receive TENS therapy will report lower pain scores and request less opioid medication than the control group. We anticipate improved control in particular in the group of women with a history of opioid use. Additionally, we believe that the TENS therapy will show benefits in other postpartum outcomes including time to bowel movement, level of sedation, and time to out of bed. Overall, we anticipate that this pilot study will support the application of TENS therapy in postpartum pain management.

Start: November 2018

Laparoscopic Repair of Cesarean Scar Niche

Evaluation of laparoscopy repair of cesarean scar niche in resolution of symptoms related to niche as compared to expectant management.

Start: March 2020