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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postpartum Hemorrhage, Cesarean Section Complications

Intervention / Treatment
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* Procedure: Clamping the uterine artery bilaterally during Cesarean section


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clamp<br>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. | Procedure: Clamping the uterine artery bilaterally during Cesarean section<br>* We 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.<br>|
| No Intervention: Control<br>Routine Cesarean section is done. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of blood loss | by measuring the suction canister | during C-section | 
| The rate of blood loss | by weighting the gauze+abdominal compress+under pads used during C-section after subtracting the tare | during C-section | 
| The rate of blood loss | by comparing the preoperative and postoperative hemoglobin and hematocrit values | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | minutes | during C-section | 
| Postoperative complications | need for relaparatomy, vascular or organ injury | postoperative 48 hours | 
| neonatal outcomes | APGAR scores | during C-section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum hemorrhage, cesarean section