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

NCT ID: NCT05948436

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2023-10-02

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.

Conditions

Postpartum Hemorrhage; Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Clamping the uterine artery bilaterally during Cesarean section

Intervention Type: PROCEDURE

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.

Control

Routine Cesarean section is done.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Ipek B. Ozcivit Erkan, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismail Cepni, Prof

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Cepni I, Hamzaoglu Canbolat K, Ozcivit Erkan IB, Sayili U, Yuksel Ozgor B, Ozak E, Mahmudova A, Madazli R, Ocal KP. The Cepni modification: using bilateral vascular clamps during caesarean section for intrapartum hemorrhage, a randomized controlled trial. J Turk Ger Gynecol Assoc. 2025 Jun 10;26(2):73-81. doi: 10.4274/jtgga.galenos.2025.2024-10-4.

Reference Type: DERIVED

PMID: 40495474 (View on PubMed)

Other Identifiers

37612

Identifier Type: -

Identifier Source: org_study_id