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Uterine Atony clinical trials

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NCT ID: NCT06192836 Not yet recruiting - Clinical trials for Cesarean Section Complications

Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage

Start date: January 10, 2024
Phase:
Study type: Observational

Postpartum hemorrhage is the leading cause of maternal deaths in all over the world, especially in developing and underdeveloped countries. Medical and surgical methods exist for management of bleeding. There are two surgical techniques for removal of the placenta on cesarean delivery, which are called manual removal and controlled cord traction. In manual removal group, the duration of surgery time might be shorter theoretically. Nevertheless, there are studies showing that manual removal of the placenta may increase postpartum endometritis and postpartum hemorrhage. The optimal method for removal of the placenta during the cesarean delivery remains uncertain (1). It is a known fact that uterine massage after vaginal birth lowers the risk of postpartum hemorrhage (2) However, there is no study on how effective uterine massage is during cesarean delivery. In 2018, Saccone and colleagues wanted to publish a meta-analysis on the role of uterine massage in reducing postpartum bleeding during cesarean delivery, but when they examined the literature on the subject, they could not find a study which included only the group that gave birth by cesarean section and was free from bias. In the same publication, it was mentioned that it was necessary to investigate the effectiveness of uterine massage, which is a cost-free method that can reduce maternal morbidity in underdeveloped countries where maternal deaths due to postpartum bleeding are high, in cesarean section. (3)

NCT ID: NCT05027048 Completed - Clinical trials for Cesarean Section Complications

Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery

CALBLOC
Start date: April 4, 2022
Phase: Phase 3
Study type: Interventional

Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Up to 80% of PPH is caused by uterine atony, the failure of the uterine smooth muscle to contract and compress the uterine vasculature after delivery. Laboratory and epidemiological studies show that low extracellular and serum calcium levels, respectively, decrease uterine contractility. A pilot study performed by the investigators supports the hypothesis that intravenous calcium chloride is well tolerated and may have utility in preventing uterine atony. The proposed research will establish the relationship between uterine tone and calcium through a clinical trial with an incorporated pharmacokinetic and pharmacodynamic (PK/PD) study. In a randomized, placebo-controlled, double-blind trial, investigators will establish the effect of 1 gram of intravenous calcium chloride upon quantitative blood loss and uterine tone during cesarean delivery in parturients with high risk of uterine atony. Investigators will concurrently collect serial venous blood samples to measure calcium for PK/PD modeling in this pregnant study cohort. High-quality clinical research and development of novel therapeutics to manage uterine atony are critical to reduce the high maternal morbidity and mortality from PPH.

NCT ID: NCT04690153 Completed - Uterine Atony Clinical Trials

Novel Approach of Hayman Uterine Compression Sutures for Management of Severe Atonic Postpartum Hemorrhage: Three Vertical Sutures

Start date: August 15, 2015
Phase:
Study type: Observational

Maternal deaths due to uterine atony bleeding are the leading causes of maternal death in our country and all over the world. In this respect, our clinic is among the clinics with the highest number of experience in our country and aims to reduce maternal deaths and mothers who will need intensive care due to bleeding with a hemorrhage stopping technique that will have a serious contribution to both our country and the world literature. Our primary goal, thanks to the bleeding-stopping technique, to reduce their deaths. Our secondary aim is, thanks to the bleeding-stopping technique we offer, To prevent and reduce the complications seen in mothers during the operative period.

NCT ID: NCT03867383 Completed - Clinical trials for Cesarean Section Complications

Calcium Chloride for Prevention of Uterine Atony During Cesarean

Start date: March 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT03584854 Active, not recruiting - Clinical trials for Postpartum Hemorrhage

Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial

Start date: March 1, 2019
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate in a randomized fashion the comparative efficacy of two second-line medications, methylergonovine and carboprost for treating atonic postpartum hemorrhage (PPH). The investigators hypothesize that administration of methylergonovine will produce superior uterine tone to carboprost in atonic PPH.

NCT ID: NCT03413917 Recruiting - Uterine Atony Clinical Trials

Exploration and Determination of Genomic Markers Predictive of Uterine Atony

Start date: February 2, 2018
Phase:
Study type: Observational

The primary objective of this study is to determine whether there are markers in the tissue of atonic uteri, and in the patients' plasma that would help identify patients likely to suffer postpartum hemorrhage due to uterine atony. We also will attempt to identify the cause(s) of uterine atony that might suggest mechanisms to prevent and manage it.

NCT ID: NCT03303235 Withdrawn - Clinical trials for Postpartum Hemorrhage

Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections

Start date: July 2020
Phase: Early Phase 1
Study type: Interventional

Insufficient uterine tone resulting in atony can potentiate hemorrhage and adverse outcomes for the parturient. Oxytocin is the first pharmacologic agent used, followed by methylergonovine, carboprost, and misoprostol. The American Congress of Obstetricians and Gynecologists (ACOG) recommends the sequential use of oxytocin, followed by methylergonovine, carboprost, misoprostol, then surgical intervention for cases of refractory uterine atony. Many studies have examined the effect and dosage of intravenous uterotonics, including oxytocin. Although there are anecdotal reports of using intravenous bolus or rapid infusion of methylergonovine, no randomized trial has compared efficacy and side effects of these two routes of administration. Investigators hypothesize that intravenous methylergonovine reduces the time to adequate uterine tone (the tone at which the uterus is adequately contracted to prevent atony after delivery of neonate), decreases the total dose of methylergonovine to contract the uterus, and therefore produces fewer side effects of hypertension, nausea, and vomiting. Reducing the time to achieve adequate uterine tone is likely to decrease postpartum hemorrhage.

NCT ID: NCT02910115 Enrolling by invitation - Blood Loss Clinical Trials

Cooling the Uterus in C-section After Dysfunctional Labor

Start date: September 2016
Phase: N/A
Study type: Interventional

The objective of the study is to demonstrate whether cooling the uterine smooth muscle during cesarean section (following delivery of the fetus) will promote better uterine contraction and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer hysterectomies following cesarean section for dysfunctional labor.

NCT ID: NCT02780245 Completed - Clinical trials for Postpartum Hemorrhage

Role of Tranexamic Acid Versus Uterine Cooling at Caesarean Section

Start date: June 2016
Phase: Phase 4
Study type: Interventional

This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum hemorrhage at secondary CS.

NCT ID: NCT02410655 Withdrawn - Clinical trials for Postpartum Hemorrhage

An Evidence Based Protocol for Oxytocin Administration in Vaginal Delivery

Start date: November 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.