Clinical Trials Directory

Trials / Completed

CompletedNCT05948436

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

The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section; A Randomized-Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
99 (actual)
Sponsor
Istanbul University - Cerrahpasa · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

Summary

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.

Detailed description

Obstetrical hemorrhage, is the most common cause of maternal mortality and morbidity that could be prevented. It can appear at early and late stage of delivery and after delivery. It Is defined as loss of more than 500 mL of blood in vaginal deliveries, whereas more than 1L of blood during C-section. The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. The incidence of postpartum anemia in Europe is 50% while in developing countries like Turkey it rises up to 50-80%. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. To preserve the hemoglobin concentrations and hemostasis and to optimize the patient's results, evidence-based methods should be performed. Given these circumstances, interventions using pharmacological, mechanical and surgical methods are necessary to minimize the blood loss. Uteroronics are the first line treatment options followed by fundal massage, controlled traction of cord and delivery of placenta, bimanual compression, intrauterine hydrostatic balloon. After these interventions, surgical interventions such as compression sutures, bilateral uterine artery ligation, hysterectomy and pelvic tamponade could be performed. In this study, we aim to decrease the amount of preoperative part of postpartum hemorrhage by clamping the uterine artery by Darmklemmen clamp after the delivery of the baby before the delivery of placenta during Cesarean delivery.

Conditions

Interventions

TypeNameDescription
PROCEDUREClamping the uterine artery bilaterally during Cesarean sectionWe clamped the uterine artery by Darmklemmen clamp, which grasps the tissue delicately without damage, after the delivery of the baby before the delivery of placenta. The clamp is released after the suturing of Munro-Kerr incision is finished, before bleeding control. The duration of clamping time is recorded.

Timeline

Start date
2023-07-10
Primary completion
2023-09-30
Completion
2023-10-02
First posted
2023-07-17
Last updated
2024-01-12

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05948436. Inclusion in this directory is not an endorsement.

The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section (NCT05948436) · Clinical Trials Directory