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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Postpartum Hemorrhage
• Intervention / Treatment: Procedure: Clamping the uterine artery bilaterally during Cesarean section

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34098
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clamp; 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; 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.
No Intervention: Control; Routine Cesarean section is done.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Study Director: Ismail Cepni, Prof, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cesarean section; postpartum hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 37612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, will ve shared after de identification. The data will be available immediately following publication. No end date. The data will be shared to anyone who wishes to access the data. It could be used for any purpose. Data will be available to anyone who proposes. Proposals should be directed to ipekbetulozcivit@gmail.com, and the link will be provided.
• IPD Sharing Time Frame: The data will be available immediately following publication. No end date.
• IPD Sharing Access Criteria: The data will be shared to anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No