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Postpartum Hemorrhage clinical trials

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NCT ID: NCT06253832 Completed - Placenta Accreta Clinical Trials

Conservative Management of Placenta Accreta Spectrum

Start date: January 4, 2020
Phase:
Study type: Observational

The resective-constructive surgery, detailed in prior research by Palacios-Jaraquemada JM, involves excising the placenta and its attachment on the myometrium, with modifications including the systematic use of a double JJ probe, omitting arterial ligation, and prioritizing careful dissection and reconstruction. A prospective single-center study conducted from January 4, 2020, to August 17, 2022, at the Tunisian maternity center included cases of placenta accreta and increta, excluding placenta percreta. Data on operative metrics, complications, transfusions, and ICU admissions were recorded. Diagnosis of placenta accreta spectrum (PAS) relied on imaging and histopathology, with exclusion criteria applied. Surgeons attained proficiency through supervised surgeries. Blood loss calculation incorporated total blood volume and hematocrit changes.

NCT ID: NCT06219538 Not yet recruiting - Clinical trials for Cesarean Section Complications

DAISY Uterine Drain Device Evaluation

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

The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction. This study defines the obstetrical surgeons as "users" and the patients in whom the drain is placed as "participants." Participants are pregnant women who are undergoing cesarean delivery (CD), who have not entered active labor, who have consented to drain placement and who have met all the inclusion/exclusion criteria. Users are staff or fellow obstetrical surgeons who will use the drain and provide the evaluation.

NCT ID: NCT06217354 Completed - Clinical trials for Post Partum Hemorrhage

Efficacy of Carbetocin in Prevention of Postpartum Hemorrhage in Obese Versus Non Obese Women

Start date: July 6, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Postpartum hemorrhage [PPH] can have serious consequences and is the leading cause of maternal mortality globally. Uterine contractility plays an important role in post-delivery uterine involution; impaired contractility can contribute to PPH. Should contractility be impaired among obese women, there would be implications for management. Therefore, the investigators sought to investigate whether obese women would also experience a need for more uterine agents during the management of an obstetric hemorrhage.

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: NCT06179147 Completed - Clinical trials for Postpartum Hemorrhage

Cervical Traction and Postpartum Hemorrhage

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

The purpose of the research conducted within the scope of the doctoral thesis study is to evaluate the effect of cervical traction applied at the end of the third stage of childbirth on the oxytocin level and postpartum bleeding (hemoglobin level, estimated blood loss, and amount of bleeding measured with a bleeding tracking bag). The study included 100 women in the intervention group and 100 women in the control group, all of whom met the inclusion criteria. Data were collected throughout the research via an Introduction Information Form, Hemoglobin and Hematocrit Measurement, Calculation of Estimated Blood Loss (modified formula of Gross (1983)), Oxytocin Measurement, and Measurement of bleeding amount with the Bleeding Tracking Bag. Blood was drawn twice from all participating women. The hemoglobin levels of the women were determined with these collected blood samples, and the change before and after the application was identified. Additionally, the oxytocin hormone in the blood was also examined. The change in oxytocin hormone levels before and after application, the difference between groups, and the change within the women themselves were identified. Besides this, the Bleeding Tracking Bag was placed under the women after the birth of the fetus and the amount of bleeding was measured. The Bleeding Tracking Bag was placed under the woman after the placenta was expelled, left for 15 minutes, and the amount of blood accumulated in the bag was recorded in "ml". "Hemoglobin and Hematocrit measurement" was performed when the woman was in the obstetrics ward, when cervical dilatation was 10 cm, and at the end of the 6th hour after birth. Blood taken into the purple cap EDTA tube was delivered daily to an external special laboratory. For determining the "oxytocin" level, 5 ml of blood was taken into the gel blood collection tube when cervical dilatation was 10 cm. After placing the bleeding tracking bag under the woman, cervical traction was applied to the intervention group for 90 seconds. To determine the effect on the oxytocin level after 15 minutes (990 seconds) of applying traction, a second 5 ml blood was taken into the gel blood collection tube. The blood taken was centrifuged by the researcher (PhD student) for 10 minutes and separated into its serum. The separated serums were pipetted into a 1.5 ml Eppendorf tube and stored at -80°C after labeling the tubes.

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: NCT06164236 Recruiting - Clinical trials for Postpartum Hemorrhage

Study of Predictors of Failure of Sulprostone Treatment in Postpartum Hemorrhage

NALAPOST
Start date: October 19, 2020
Phase:
Study type: Observational

The investigators wish to identify potential factors predicting failure of second-line drug treatment (sulproston (Nalador®)): risk factors and factors linked to a failure to take initial care for PPH. A better understanding of the aggravating factors of HPP and more particularly the factors inherent to the initial care would make it possible to think of ways to improve practices.

NCT ID: NCT06159959 Completed - Clinical trials for Post Partum Hemorrhage

Carbetocin in the Prevention of Primary Postpartum Haemorrhage

Start date: January 1, 2023
Phase:
Study type: Observational

Postpartum haemorrhage (PPH) ranks as the first cause of maternal mortality in developing countries and it is the cause of 25% of maternal deaths worldwide. Carbetocin is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions and increased uterine tone.

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.