Four Different Methods of Performing External Aortic Compression After Caesarean Section

NCT06157307 | Unknown DMC

• 1 other identifier: AAronsson
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

After childbirth, bleeding from the uterus occurs, which can quickly become very profuse if the uterus does not contract. Annually, around 80000 women die because profuse bleeding associated with childbirth, mainly in low -and middle income countries. By pressing a fist on the outside of the abdomen in the umbilical plane (aortic compression) the abdominal artery is compressed, which directly reduces the bleeding from the uterus and any bleeding from the birth canal. The goal of this small clinical trial is to compare four different ways of performing aortic compression in healthy women directly after a planned uncomplicated cesarean section. The main questions aim to answer are:

• Is there a difference in how well aortic compression works, defined as cessation of blood flow in the inguinal artery measured by ultrasound, when applying aortic compression with the fist positioned in the transverse plane or longitudinally, compared to the fingertips and a fist protector
• Does the researcher experience a difference between the four different methods? The study takes place in the operating room immediately the cesarean sectio is complete. The participant will then still have the effect of the spinal anesthetic. The researcher begin the trial by recording vital signs: heart rate and electrical activity, blood pressure and the amount of oxygen in the blood. Ultrasound will be used to see the blood flow in the right inguinal artery. If everything is normal, the researcher will apply aortic compression in four different ways. The researcher will start aortic compression with the fingertips, then with a fist placed lengthwise. After that with the fist across the abdomen and then with a fist protector. At each occasion there will be a maximum of 5 seconds of total occlusion of the abdominal artery. Cessation of blood flow in the inguina artery becomes the criterion for total compression of the abdominal artery below the umbilicus. After the trial, the participant will be transferred to the post-operative ward, where, in addition to standard monitoring, you are also observed for 30 minutes by of the researcher. The study is carried out at Karolinska University Hospital and takes approximately 20 minutes, including preparation. There are no clinical benefits for the participants. Increased knowledge of different ways of performing aortic compression can contribute to better treatment of women with profuse bleeding after childbirth.

Conditions

Postpartum Hemorrhage

Keywords

Aortic compression

Outcome Measures

Primary Outcomes (1)

• Femoral blood flow

  The primary endpoint is the cessation of pulsation in the femoral artery measured by ultrasound.

  60 seconds

Secondary Outcomes (1)

• investigator experience

  60 seconds

Study Arms (1)

Test subjects

EXPERIMENTAL

Four different hand placements for aortic compression.

Device: Aortic compression

Interventions

Aortic compression DEVICE

Aortic compression with four different methods on each participants

Test subjects

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal pregnancy
• No ongoing medication
• BMI 18.5-30
• Proficient Swedish language skills
• Uncomplicated caesarean sectio

You may not qualify if:

• Tobacco/Nicotine use
• Any ongoing medication
• Any chronic disease except seasonal allergy
• Previous abdominal surgery
• Complicated caesarean section

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annette Aronsson, MD,PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Lindblad Wollmann, MD, PhD

CONTACT

+46707912068; charlotte.lindblad-wollmann@regionstockholm.se

Clara Brandkvist, MD

CONTACT

+46702252726; clara.brandkvist@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: November 30, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 8, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share