Uterine Fundus Pressure in Reduction of Cesarean Bleeding

NCT06005831 | Completed

• 1 other identifier: 2020/14-02
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine compression methods reduce the amount of postpartum bleeding. In our study, we investigated the effect of fundal pressure, which will be created by a sandbag placed on the abdomen, on reducing post-cesarean bleeding. Material and Methods: A total of 482 patients who delivered by cesarean section (CS) in the Obstetrics Clinic of Fırat University Faculty of Medicine between January 2021 and December 2021 were included in this prospective, randomized, single-center study.

Conditions

Postoperative Bleeding

Keywords

cesarean section; fundal pressure; postoperative bleeding; sandbag

Outcome Measures

Primary Outcomes (1)

• Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.

  Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.

  24 hours

Study Arms (1)

Sandbag

OTHER

Sandbag

Other: sandbag

Interventions

sandbag OTHER

The standard sandbag used in our clinic, 20 × 20 × 3 cm3 in dimensions and 3 kg in weight

Sandbag

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Uterine compression methods reduce the amount of postpartum bleeding
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the study.

You may not qualify if:

• Invasion anomaly,
• Diagnosed with preeclampsia,
• Placenta previa cases,
• Hypertensive pregnant women receiving antihypertensive therapy,
• Diabetic pregnant women,
• Multiple pregnancies,
• Major hepatic, cardiac, renal, respiratory disorders
• Deep vein thrombosis during pregnancy,
• Receiving anticoagulant therapy
• Patients who developed atony and uterine rupture in the operating room,
• Suspected placental invasion
• Uterine balloon tamponade
• Arterial embolization
• Uterine and hypogastric artery ligation,
• Uterine compression sutures

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat University Faculty of Medicine

Elâzığ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Sehmus Pala

  University of Firat

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The 482 patients who had CS were divided into two groups, control group (n = 246), weighted group (n = 236) was randomized.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Firat University

Model Details: It is a prospective, randomized, controlled single-center study.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 23, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)