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Postpartum Hemorrhage clinical trials

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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: NCT06025916 Recruiting - PPH Clinical Trials

Postpartum Hemorrhage Reduction With Oral Tranexamic Acid: a Clinical Trial

PROTECT
Start date: September 27, 2023
Phase: Phase 4
Study type: Interventional

This is a multicentre randomized placebo-controlled double-blinded phase IV study among 1000 women in Sweden and South Africa on the effect of oral tranexamic acid on PPH after vaginal delivery. The main purpose of the study is to evaluate the effect of orally administered tranexamic acid (TA) compared to placebo on rate of postpartum hemorrhage (PPH) after vaginal birth. Participants will be randomized to receive either 20 ml (2g) of the investigational medicinal product (TA100mg/ml) or 20ml of a placebo solution during labor. Our main endpoint, assessed at 24 hours after delivery is PPH defined as blood loss >=500ml and assessed both by weight and pre-postpartum hemoglobin (Hb) decrease >10 units difference in vaginal deliveries

NCT ID: NCT06011096 Completed - Clinical trials for Postpartum Hemorrhage

The Effect of Skin-to-skin Contact on Placental Separation Time, Type, Postpartum Hemorrhage and Comfort

Start date: November 2, 2022
Phase: N/A
Study type: Interventional

It is aimed to determine the late cord clamping with early skin-to-skin contact in primiparous pregnant women who delivered vaginally, according to placental separation time, separation method, amount of postpartum bleeding and postpartum comfort.

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).

NCT ID: NCT06002256 Completed - Clinical trials for Post-partum Hemorrhage

Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage

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

The current study aimed to investigate the effectiveness of the Mostafa Maged maneuver compared to Bimanual uterine compression in controlling postpartum hemorrhage during vaginal delivery. The study subjects were categorized into two groups. The first group was managed by the Mostafa Maged maneuver , whereas the second group was managed by routine bimanual uterine compression. investigators attempted to determine the duration of each maneuver required until the investigator became exhausted, as well as whether or not oxytocin was administered later in each maneuver .

NCT ID: NCT05979701 Not yet recruiting - Clinical trials for Postpartum Hemorrhage

Simulation for the Retention of Skills in the Management of Obstetric Hemorrhages

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

The aim of this study is to evaluate the retention of knowledge and skills after theory+simulation training versus theoretical training alone in postpartum haemorrhage immediately, 3 months and 6 months after training in South Kivu, in the east of the Democratic Republic of Congo.

NCT ID: NCT05977686 Not yet recruiting - Clinical trials for Post Partum Hemorrhage

Hemoglobin Testing in Pregnant Patients

Prosp Anemia
Start date: April 2024
Phase:
Study type: Observational

The project is a prospective observational study aimed to assess and to validate the use of point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3) provide immediate results for real-time patient counseling and intervention. However, to date, point-of-care hemoglobin testing devices have not yet been studied for use in an ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter, manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement. Participants in this study will be approached at the Obstetrics and Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin measurements will be assessed using the non-invasive Masimo device along with minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture hemoglobin testing.

NCT ID: NCT05973747 Completed - Pregnancy Related Clinical Trials

Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

Start date: August 19, 2023
Phase: Early Phase 1
Study type: Interventional

Calcium is a life saving medicine in the care of parturients. It has many important uses including treatment of hypocalcemia, treatment of magnesium toxicity, prevention of hypocalcemia during blood transfusion (of citrate containing blood products), treatment of hyperkalemia, and others. Recent clinical trials also suggest that calcium given after cord clamping may decrease blood loss in patients undergoing cesarean delivery. 2 FDA approved forms of calcium can be given intravenously: calcium chloride and calcium gluconate. Over the last decade there have been times with drug shortages of either calcium chloride or calcium gluconate. So there have been and likely will continue to be times when one formulation or the other may not be adequately available. Despite the importance of calcium and the frequency in which it is used in parturients, there are no published studies in parturients to determine dose equivalence between calcium gluconate and calcium chloride. In this study the investigators will determine the population pharmacokinetics of calcium gluconate and calcium chloride in parturients and calculate the dose equivalent ratio the two drugs. This will help clinicians select appropriate doses of calcium and provide resilience to the drug supply chain in our era of frequent drug shortages.