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Cesarean Section Complications clinical trials

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NCT ID: NCT03710317 Completed - Clinical trials for Cesarean Section Complications

Carbetocin Versus Buccal Misoprostol Plus IV Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond our reach unless we prioritize the prevention and treatment of postpartum hemorrhage(PPH) in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) and in the third stage of labor for vaginal delivery has become essential to diminish the risk of PPH and improve maternal safety. Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated as much. The buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min. A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection. The aim of this study was to compare the effectiveness of combined buccal misoprostol and IV tranexamic acid (TA)with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.

NCT ID: NCT03710304 Completed - Clinical trials for Cesarean Section Complications

Tranexamic Acid Plus Buccal Misoprostol on Blood Loss During and After Cesarean Delivery

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. The risk of PPH is much higher for women undergoing cesarean delivery (CD). In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond our reach unless we prioritize the prevention and treatment of PPH in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) and in the third stage of labor for vaginal delivery has become essential to diminish the risk of PPH and improve maternal safety. Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CD has not been investigated as much. The buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. Tranexamic acid(TA) is a synthetic analog of the amino acid lysine,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analog; ε-aminocaproic acid. The aim of this study was to compare the effectiveness of combined buccal misoprostol and intravenous TA with intravenous oxytocin for the prevention of PPH in patients with risk factors during cesarean section.

NCT ID: NCT03706755 Completed - Anesthesia Clinical Trials

Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia

Start date: May 3, 2018
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine the more effective intravenous bolus of norepinephrine for maintaining blood pressure during a spinal anesthesia for a cesarean delivery with the fewer side effects. Low blood pressure has been shown to decrease uterine perfusion and foetal outcomes during cesarean delivery under spinal anesthesia. For elective or semi-urgent cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and either sufentanil or fentanyl. This study plans to enroll 124 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

NCT ID: NCT03706339 Completed - Clinical trials for Cesarean Section Complications

Reducing Blood Loss During Cesarean Section by Topical Versus IV Tranexamic Acid

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Tranexamic (TXA)acid is an inexpensive, antifibrinolytic drug long used to control bleeding due to surgery, menorrhagia, or trauma. Additionally, tranexamic acid has been shown to reduce bleeding during cesarean delivery as well as the need for additional uterotonic agents, albeit to a minimal degree. However, previous studies have been performed only in women with a standard risk for postpartum hemorrhage( PPH) and have not focused on assessing the effects of tranexamic acid in high‐risk women. The aim of this study is to evaluate the efficacy of IV versus topical application of tranexamic acid in reducing blood loss during and after elective C.S. The Research Question Is topical application of Tranexamic acid effective in reducing blood loss during and after an elective Caesarean section? The Research Hypothesis the TXA could be able to reduce blood loss during and after elective Caesarean section. The null hypothesis will, therefore, state that: There will be no difference between topical and IV TXA and placebo in reducing blood loss during and after elective Caesarean section.

NCT ID: NCT03701048 Completed - Clinical trials for Cesarean Section Complications

Rectus Musle Reapproximation During Cesarean Section

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

NCT ID: NCT03678675 Completed - Clinical trials for Cesarean Section Complications

Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial

Start date: May 30, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.

NCT ID: NCT03668535 Completed - Clinical trials for Cesarean Section Complications

Filling of the Urinary Bladder During Difficult Cesarean Section

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Risk factors for bladder injury during Cesarean Section are well known. Most of cases of bladder injury occur in presence of previous Cesarean Sections, morbidly adherent placenta, or previous bladder injury. limited evidence suggest that bladder filling may decrease the incidence of bladder injury. n our study, we compared the outcome of urinary bladder filling during Cesarean Section in cases at high risk of bladder injury.

NCT ID: NCT03640702 Completed - Clinical trials for Cesarean Section Complications

The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes

Start date: August 1, 2017
Phase:
Study type: Observational

The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes. The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.

NCT ID: NCT03629028 Completed - Clinical trials for Cesarean Section Complications

Single or Double-layer Uterine Closure Techniques

Start date: August 18, 2018
Phase: N/A
Study type: Interventional

There are different surgical techniques of uterine closure during cesarean. A growing data has suggested that the closure technique has an effect on uterine scar healing. Residual myometrium thickness and uterine scar defect (niche) development seems to be related to the single or double layer closure of uterus. In that study, investigators will search for the effect of single or double layer closure of uterus during cesarean on the uterine scar defect.

NCT ID: NCT03598764 Completed - Clinical trials for Cesarean Section Complications

External Pop-out and Classic Fetal Head Extract During Cesarean Section

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Cesarean section is the delivery of the fetus through a surgical incision in the abdominal wall (laparotomy) and uterine wall (hysterotomy). The rate of cesarean delivery has increased progressively in the last decades until it becomes the most common operation performed all over the world. A multitude of efforts had been done aiming at a reduction of cesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions. The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8%. Delivery of the fetal head through the uterine incision is one of the major technical problems during elective cesarean section, especially when the presenting part is non-engaged. All of the previously described procedures, alternative to the classic manual head extraction, were inconclusive and not convincing to the obstetricians for routine use. Also, no reported well-designed trials favor one of them over other. Application of vacuum cup, use of forceps blade, increasing fundal pressure and making additional uterine incisions were previously reported as alternative techniques. None of them gain any popularity or proved to be used as a basic step during cesarean section, besides many complications were reported due to their use on mothers and infants. The vulnerability of the lower uterine segment for tears is related to the stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively. As with any surgical operation, anticipating difficulties during cesarean delivery and avoiding these difficulties is always the greatest practice. Although much has been written about techniques for managing difficult head extraction during vaginal deliveries, the reports addressed the management of difficult head delivery during cesarean section in literature are scarce. The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment. This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection, adhesion and blood transfusion. Adherence to the available the generated good quality evidence bases practice in cesarean section is anticipated to decrease such morbidities. The idea of the present technique was derived from the fact that during vaginal delivery the main task of the obstetrician is to support the perineum while the fetal head extends to get out through birth canal.