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

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ClinicalTrials.gov Identifier: NCT05948436
Recruitment Status : Completed
First Posted : July 17, 2023
Last Update Posted : January 12, 2024
Sponsor:
Information provided by (Responsible Party):
Ipek B. Ozcivit Erkan, MD, Istanbul University - Cerrahpasa (IUC)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Cesarean Section Complications Procedure: Clamping the uterine artery bilaterally during Cesarean section Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section; A Randomized-Controlled Trial
Actual Study Start Date : July 10, 2023
Actual Primary Completion Date : September 30, 2023
Actual Study Completion Date : October 2, 2023

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The rate of blood loss [ Time Frame: during C-section ]
    by measuring the suction canister

  2. The rate of blood loss [ Time Frame: during C-section ]
    by weighting the gauze+abdominal compress+under pads used during C-section after subtracting the tare

  3. The rate of blood loss [ Time Frame: 24 hours ]
    by comparing the preoperative and postoperative hemoglobin and hematocrit values


Secondary Outcome Measures :
  1. Operation time [ Time Frame: during C-section ]
    minutes

  2. Postoperative complications [ Time Frame: postoperative 48 hours ]
    need for relaparatomy, vascular or organ injury

  3. neonatal outcomes [ Time Frame: during C-section ]
    APGAR scores


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05948436


Locations
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Turkey
Istanbul University-Cerrahpasa
Istanbul, Turkey, 34098
Sponsors and Collaborators
Istanbul University - Cerrahpasa (IUC)
Investigators
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Study Director: Ismail Cepni, Prof Istanbul University - Cerrahpasa (IUC)
More Information
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Responsible Party: Ipek B. Ozcivit Erkan, MD, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier: NCT05948436    
Other Study ID Numbers: 37612
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The data will be available immediately following publication. No end date.
Access Criteria: The data will be shared to anyone who wishes to access the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ipek B. Ozcivit Erkan, MD, Istanbul University - Cerrahpasa (IUC):
postpartum hemorrhage
cesarean section
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Puerperal Disorders
Uterine Hemorrhage