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

Primary Purpose

Postpartum Hemorrhage, Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Clamping the uterine artery bilaterally during Cesarean section
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring postpartum hemorrhage, cesarean section

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Clamp

Control

Arm 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.

Routine Cesarean section is done.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Operation time
minutes
Postoperative complications
need for relaparatomy, vascular or organ injury
neonatal outcomes
APGAR scores

Full Information

First Posted
July 10, 2023
Last Updated
October 2, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05948436
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
October 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Cesarean Section Complications
Keywords
postpartum hemorrhage, cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clamp
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine Cesarean section is done.
Intervention Type
Procedure
Intervention Name(s)
Clamping the uterine artery bilaterally during Cesarean section
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of blood loss
Description
by measuring the suction canister
Time Frame
during C-section
Title
The rate of blood loss
Description
by weighting the gauze+abdominal compress+under pads used during C-section after subtracting the tare
Time Frame
during C-section
Title
The rate of blood loss
Description
by comparing the preoperative and postoperative hemoglobin and hematocrit values
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Operation time
Description
minutes
Time Frame
during C-section
Title
Postoperative complications
Description
need for relaparatomy, vascular or organ injury
Time Frame
postoperative 48 hours
Title
neonatal outcomes
Description
APGAR scores
Time Frame
during C-section

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Cepni, Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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