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

Istanbul University - Cerrahpasa (IUC)

Status: Completed

Conditions: Cesarean Section Complications; Postpartum Hemorrhage

Treatments: Procedure: Clamping the uterine artery bilaterally during Cesarean section

Study type: Interventional

Funder types: Other

Identifiers

NCT05948436

37612

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Clamp

Experimental group

Description:

In 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.

Treatment:

Procedure: Clamping the uterine artery bilaterally during Cesarean section

Control

No Intervention group

Description:

Routine Cesarean section is done.