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Postpartum Hemorrhage clinical trials

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NCT ID: NCT06431204 Not yet recruiting - Clinical trials for Cesarean Section Complications

Obstetric Comorbidity Index in Postpartum Hemorrhage

Start date: May 20, 2024
Phase:
Study type: Observational

The objective of this study is to examine the predictive capability of the Obstetric comorbidity index in the identification of severe maternal morbidity associated with postpartum hemorrhage in patients undergoing cesarean delivery.

NCT ID: NCT06358768 Not yet recruiting - Clinical trials for PPH - Postpartum Hemorrhage

Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations

PPH
Start date: May 1, 2024
Phase:
Study type: Observational [Patient Registry]

Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management

NCT ID: NCT06333340 Not yet recruiting - Clinical trials for Post Partum Hemorrhage

Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery

Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH. This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa. The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.

NCT ID: NCT06255002 Not yet recruiting - Clinical trials for Postpartum Hemorrhage

Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabs®FIB Analyzer and Its Measurement by Conventional Method (Clauss Fibrinogen) in the Context of Severe Postpartum Haemorrhage

FIB-HPPS
Start date: March 2024
Phase:
Study type: Observational

In France in 2021, 11.6% of deliveries were complicated by a postpartum haemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by the Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.

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: NCT06166771 Not yet recruiting - PPH Clinical Trials

Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage

"Alma system"
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Prospective, non-randomized, feasibility pilot study Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur immediately after vaginal birth or cesarean section. In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth. Prospective, non-randomized, feasibility pilot study The purpose of this study, clinical trial, is to obtain information on the safety and effectiveness of the investigational new medical device - Alma System,. Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage. The main questions are: 1. Rate of device related SAE up to six weeks following device treatment. 2. Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure. 3. Rate of occurrence of uterine inversion of folding during or immediately after device procedure. main tasks for participants: - sign the informed Consent form and enrolment - In case of PPH, treatment with Alma - Participate in 2 visit followup After the treatment- 1st upon discharge and 2nd after 8 weeks.

NCT ID: NCT06157307 Not yet recruiting - Clinical trials for Postpartum Hemorrhage

Four Different Methods of Performing External Aortic Compression After Caesarean Section

KEXAC
Start date: November 30, 2023
Phase: N/A
Study type: Interventional

After childbirth, bleeding from the uterus occurs, which can quickly become very profuse if the uterus does not contract. Annually, around 80000 women die because profuse bleeding associated with childbirth, mainly in low -and middle income countries. By pressing a fist on the outside of the abdomen in the umbilical plane (aortic compression) the abdominal artery is compressed, which directly reduces the bleeding from the uterus and any bleeding from the birth canal. The goal of this small clinical trial is to compare four different ways of performing aortic compression in healthy women directly after a planned uncomplicated cesarean section. The main questions aim to answer are: - Is there a difference in how well aortic compression works, defined as cessation of blood flow in the inguinal artery measured by ultrasound, when applying aortic compression with the fist positioned in the transverse plane or longitudinally, compared to the fingertips and a fist protector - Does the researcher experience a difference between the four different methods? The study takes place in the operating room immediately the cesarean sectio is complete. The participant will then still have the effect of the spinal anesthetic. The researcher begin the trial by recording vital signs: heart rate and electrical activity, blood pressure and the amount of oxygen in the blood. Ultrasound will be used to see the blood flow in the right inguinal artery. If everything is normal, the researcher will apply aortic compression in four different ways. The researcher will start aortic compression with the fingertips, then with a fist placed lengthwise. After that with the fist across the abdomen and then with a fist protector. At each occasion there will be a maximum of 5 seconds of total occlusion of the abdominal artery. Cessation of blood flow in the inguina artery becomes the criterion for total compression of the abdominal artery below the umbilicus. After the trial, the participant will be transferred to the post-operative ward, where, in addition to standard monitoring, you are also observed for 30 minutes by of the researcher. The study is carried out at Karolinska University Hospital and takes approximately 20 minutes, including preparation. There are no clinical benefits for the participants. Increased knowledge of different ways of performing aortic compression can contribute to better treatment of women with profuse bleeding after childbirth.

NCT ID: NCT06060327 Not yet recruiting - Clinical trials for Cesarean Section Complications

Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

The study will include 444 pregnant patients undergoing cesarean section in Kasr Al Aini. Following a proper medical history taking, examination will be done, investigations including laboratory tests and obstetric ultrasound will be done. Then, the patients will be divided into 4 groups, receiving Oxytocin only (Group 1), Oxytocin + Tranexamic acid (Group 2), Oxtytocin and Misoprostol (Group 3) or Oxytocin and Carbetocin (Group 4) followed by collection of necessary data.

NCT ID: NCT06033170 Not yet recruiting - Clinical trials for Postpartum Hemorrhage

Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

Start date: September 2023
Phase: N/A
Study type: Interventional

This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage (PPH).

NCT ID: NCT06010368 Not yet recruiting - Clinical trials for Cesarean Section Complications

Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent research has shown Egypt to be the third-largest country globally, with an estimated 52% cesarean sections (3). However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter of blood following a vaginal birth and losing over one thousand milliliter after the cesarean section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in poor countries, and the estimated mortality number due to postpartum bleeding is one hundred thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to diminish maternal mortality and morbidity (7). The most successful technique for decreasing PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).