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

Not Applicable
Completed
Conditions
Postpartum Hemorrhage
Cesarean Section Complications
Interventions
Procedure: Clamping the uterine artery bilaterally during Cesarean section
Registration Number
NCT05948436
Lead Sponsor
Istanbul University - Cerrahpasa (IUC)
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
99
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ClampClamping the uterine artery bilaterally during Cesarean sectionIn these patients, we clamped the uterine artery by Darmklemmen clamp after the delivery of the baby before the delivery of placenta. We released the clamp after the suturing of the uterus is finished.
Primary Outcome Measures
NameTimeMethod
The rate of blood loss24 hours

by comparing the preoperative and postoperative hemoglobin and hematocrit values

Secondary Outcome Measures
NameTimeMethod
neonatal outcomesduring C-section

APGAR scores

Operation timeduring C-section

minutes

Postoperative complicationspostoperative 48 hours

need for relaparatomy, vascular or organ injury

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa

🇹🇷

Istanbul, Turkey

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