NCT05948436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

July 10, 2023

Last Update Submit

January 11, 2024

Conditions

Postpartum HemorrhageCesarean Section Complications

Keywords

postpartum hemorrhagecesarean section

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Operation time

    during C-section

  • Postoperative complications

    postoperative 48 hours

  • neonatal outcomes

    during C-section

Study Arms (2)

Clamp

EXPERIMENTAL

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

Control

NO INTERVENTION

Routine Cesarean section is done.

Interventions

Clamping the uterine artery bilaterally during Cesarean sectionPROCEDURE

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.

Clamp

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women gave birth \>37 GW
  • singleton pregnancy
  • with normal fetal development
  • Not emergency C-section

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 40495474DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ismail Cepni, Prof

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 17, 2023

Study Start

July 10, 2023

Primary Completion

September 30, 2023

Study Completion

October 2, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations

TU(1)