Clinical trial NCT05948436: The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section
Official title: The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section; A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Cesarean Section Complications
Keywords: postpartum hemorrhage
cesarean section
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 99
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women gave birth \>37 GW
* singleton pregnancy
* with normal fetal development
* Not emergency C-section

Exclusion Criteria:

* C/sections with indications of plasenta prevue or placenta acrreta spectrum
* with amniotic fluid abnormalities
* multiple pregnancies
* threatened preterm labor
* who have preeclampsia or other type of obstetrical complications
* maternal obesity (BMI\>30kg/m2)
* maternal cardiovascular disease, hypertension, coagulation defects, women who use anticoagulants
* patients who underwent Cesarean section during active labor

Primary outcomes:
measure: The rate of blood loss
timeFrame: during C-section
measure: The rate of blood loss
timeFrame: during C-section
measure: The rate of blood loss
timeFrame: 24 hours
Secondary outcomes:
measure: Operation time
timeFrame: during C-section
measure: Postoperative complications
timeFrame: postoperative 48 hours
measure: neonatal outcomes
timeFrame: during C-section
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ismail Cepni, Prof
role: STUDY_DIRECTOR
References: