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Postpartum Hemorrhage clinical trials

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NCT ID: NCT05948436 Completed - Clinical trials for Cesarean Section Complications

The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. In this study, we aim to decrease the amount of postpartum hemorrhage by clamping the uterine artery after the delivery of the baby during Cesarean delivery.

NCT ID: NCT05928481 Completed - Clinical trials for Postpartum Hemorrhage

The Effect Of Sımulatıon-Based Postpartum Bleedıng Management On Mıdwıfery Students

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

This study was planned to determine the effect of simulation-based postpartum hemorrhage management on the application skills, satisfaction, self-confidence and self-efficacy-competences of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department 3rd year students. The research, which was planned in a randomized controlled experimental design, will be conducted with Istanbul Health Sciences University Hamidiye Health Sciences Faculty 3rd year midwifery (N:82) students. Students participating in the study will be divided into intervention (n:41) and control (n:41) groups according to the computer-assisted simple random sampling technique. Before the application, both groups will be given 2 hours of theoretical information on the evaluation and management of postpartum hemorrhage. 41 students assigned to the intervention group will be given a high-fidelity simulator, and 41 students assigned to the control group will be given practical training accompanied by an adult standard patient care model. "Descriptive Information Form", "Evaluation of Simulation-Based Learning Scale", "Student Satisfaction and Self-Confidence in Learning Scale", "Self-Efficacy Scale" and "Early Postpartum Hemorrhage Management Skill Evaluation Form" will be applied to the students participating in the research.

NCT ID: NCT05924321 Completed - Clinical trials for Postpartum Hemorrhage

A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects

Start date: May 25, 2023
Phase: Phase 1
Study type: Interventional

Carbetocin is an oxytocin receptor agonist that selectively binds to receptors in the smooth muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterine musculature. Carbetocin is approved in >100 countries for the prevention of postpartum hemorrhage due to uterine atony in women following cesarean or vaginal delivery. Per regulatory requirements, the current trial will evaluate the effects of high clinical exposure of carbetocin on the QT interval corrected for heart rate (QTc) as measured by ECG in healthy men and women.

NCT ID: NCT05811676 Recruiting - Placenta Previa Clinical Trials

Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa

TRAPP
Start date: July 12, 2023
Phase: Phase 3
Study type: Interventional

Many RCT(randomized controlled trial) studies reported that tranexamic acid reduced blood loss in women who had elective cesareans. However, most of these elective cesareans are without high-risk factors of postpartum hemorrhage, such as placenta previa. The prophylactic use of tranexamic acid in the placenta previa is not clear. studies had poor quality and lacked adequate power to assess severe adverse events.

NCT ID: NCT05772156 Recruiting - Clinical trials for Postpartum Hemorrhage

Prophylactic Methylergonovine for Twin Cesarean

Start date: March 7, 2023
Phase: Phase 4
Study type: Interventional

Obstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity following cesarean delivery. Twin gestations (twin pregnancy) are at particularly higher risk for postpartum hemorrhage, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery. The purpose of this study is to understand the effect of prophylactic methylergonovine on blood loss in scheduled twin pregnancy cesarean deliveries. Participants will be randomized (like tossing a coin) to Methylergonovine (investigational drug) or water with salt (saline) (placebo). Methylergonovine or saline will be given as an injection immediately after delivery.

NCT ID: NCT05759156 Completed - Clinical trials for Cesarean Section Complications

Tranexamic Acid in Patients for Caesarian Delivery.

TXA; CD
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.

NCT ID: NCT05670886 Recruiting - Clinical trials for Postpartum Hemorrhage

Routine Bilateral Uterine Artery Ligation During the Cesarean Delivery of Multiple Gestation

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Multiple pregnancy is well defined to be associated with a greater risk of postpartum blood loss . Interventions to control PPH generally stepped from less to more invasive and including compression maneuvers , drugs , and further radical surgeries. Conservative management plans such as medications which cause the uterus to contract, external massage to the uterine body , and bimanual compression are overall used as 1st line interventions. PPH was defined as a cumulative blood loss of 1,000 mL or more, or blood loss that occurred within 24 hours of childbirth and was accompanied by indications or symptoms of hypervolemia. The most frequent cause of PPH, which accounted for roughly 80% of cases, is uterine atony (3). PPH is brought on by hyperexpansion, which impaired uterine myometrial contractility and caused uterine contraction fatigue , PPH were twice as high when pregnant with twins (4).The only effective surgical treatment for blood loss is a hysterectomy, but this is a risky procedure, especially for young women.(5) Due to this, a number of fertility-preserving surgical procedures have been developed, including the B-Lynch technique, internal iliac artery ligation, and uterine artery ligation (UAL) One of the most widely used surgical methods for preserving fertility is UAL. It is simple to carry out and works well to control PPH. Additionally, it permits patients to have more children in the future and is generally safe. Additionally, it has a success rate of above 90%. Concerns have been raised about its effect on women who want to become pregnant in the future regarding their ovarian reserve. The accepted practice of medicine worldwide is the prophylactic use of uterotonics. A synthetic oxytocin analogue with a lengthy half-life, carbetocin also stimulates uterine contractions . One benefit of carbetocin over oxytocin is that it is more heat-stable, which is of greater importance to low resource settings . Studies compare the effectiveness of carbetocin and oxytocin in preventing PPH and find that carbetocin is equally effective or even more effective.

NCT ID: NCT05647538 Completed - Pregnancy Outcome Clinical Trials

Bilateral Uterine Artery Ligation After Intrapartum or Postpartum Hemorrhage on Ovarian Reserve Markers and Pregnancy Outcome

Start date: June 1, 2020
Phase:
Study type: Observational

The aim of this study is to assess the possible negative effects of uterine artery ligation on ovarian reserve markers and subsequent pregnancy outcomes

NCT ID: NCT05610345 Completed - Clinical trials for Postpartum Hemorrhage

The Effect of Placental Cord Drainage on Postpartum Blood Loss

Start date: November 12, 2022
Phase: N/A
Study type: Interventional

To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery

NCT ID: NCT05598502 Recruiting - Clinical trials for Post-partum Hemorrhage

REBOA in Life-threatening Postpartum Hemorrhage (PPH) in Uganda

REBOA-PPH
Start date: January 17, 2024
Phase: N/A
Study type: Interventional

Background Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum haemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda. Large parts of the monitoring of mothers during active management of third stage of labour is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. A balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of balloon occlusion time including repeated short balloon deflations. Objective To assess the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda. Study design, setting and population A phase IIb/III, open label, 1:1 randomized clinical trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda, to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care. The inclusion criteria are: a) women with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg, b) written consent. The exclusion criterion is prior cardiac arrest or intra-abdominal pregnancy. The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 50% and 85% of the total sample size, and a final analysis with full sample size. Utility of the study It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum haemorrhage in Uganda and the rest of the world.