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

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05948436
Collaborator
(none)
80
1
2
2.7
29.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Clamping the uterine artery bilaterally during Cesarean section
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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 :
Jul 10, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. The rate of blood loss [during C-section]

    by measuring the suction

  2. The rate of blood loss [during C-section]

    by weighting the gauze used during C-section after subtracting the tare

  3. The rate of blood loss [24 hours]

    by comparing the preoperative and postoperative hemoglobin values

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpasa Istanbul Turkey 34098

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ipek B. Ozcivit Erkan, MD, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT05948436
Other Study ID Numbers:
  • 37612
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jul 1, 2023
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, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2023