Aortic Compression Trial to Reduce Blood Loss at Cesarean Section

NCT05312658 | Enrolling By Invitation DMC

• 1 other identifier: 2021-06579
• Study Type: interventional
• Target: 2,246
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test if manual external aortic compression can prevent heavy blood loss in cesarean section. The main question\[s\] it aims to answer are:

1. 1.Is external aortic compression effective?
2. 2.Is external aortic compression safe?

Conditions

Post Partum Hemorrhage; Cesarean Section Complications; Anemia

Keywords

Aortic compression; Post partum hemorrhage; Anemia; Cesarean section

Outcome Measures

Primary Outcomes (1)

• Calculated peripartum hemorrhage

  Calculated estimated blood loss greater than 1000 ml or a red-cell transfusion within 48 hours after delivery. The calculated estimated blood loss = the estimated blood volume × (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. The estimated blood volume in milliliters is calculated as the admission body weight in kilograms × 85.

  0-2 days postpartum

Secondary Outcomes (5)

• Gravimetrically estimated peripartum hemorrhage (g) or blood transfusion

  0-2 hours postpartum

• Total blood loss

  0-1 days postpartum

• Transfusion

  0-2 days postpartum

• Maternal higher-level care

  0-7 days postpartum

• Severe maternal morbidity

  0-42 days postpartum

Other Outcomes (32)

• Blood loss, exploratory outcome B-Hb

  0-7 days postpartum

• Blood loss, exploratory outcome B-EVF (hematocrit)

  0-7 days postpartum

• Blood loss, exploratory outcome Anemia

  0-7 days postpartum

Study Arms (2)

Routine external aortic compression

EXPERIMENTAL

The assistant surgeon or nurse places heel of the hand or fist over the abdominal aorta immediately after the baby is born while the surgeon helps the baby out, the placenta is expulsed or fetched, and the surgeon gains control over bleeding. The compression should be held until controlled bleedning, for example until the first layer of the uterine incision is sutured. Maximum time of aortic compression is 20 minutes, then a 5 minute break is required, after which compression may be reapplied.

Procedure: External aortic compression

No external aortic compression

NO INTERVENTION

No routine aortic compression. If deemed vital to the mother, aortic compression should be exerted. Aortic compression may be exerted if bleeding exceeds 1000 ml.

Interventions

External aortic compression PROCEDURE

External aortic compression by assistant in cesarean section.

Routine external aortic compression

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned cesarean delivery
• Live fetus/fetuses if multiple pregnancy
• Gestational week 34+0 or more

You may not qualify if:

• Preoperative B-Hemoglobin \<100 g/l
• Planned hysterectomy in the same procedure as the planned cesarean delivery
• Other condition as deemed by attending surgeon.

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Danderyd Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

  PMID: 32609374 BACKGROUND

Related Links

• Swedish network for national clinical studies in Obstetrics and Gynecology, information about ACT in Swedish

MeSH Terms

Conditions

Postpartum Hemorrhage; Anemia

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; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sophia Brismar Wendel, MD, PhD

  Danderyd Hospital Karolinska Institutet, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, PhD

Model Details: 1:1 randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From one year after the trial is finalized with no upper limit.
• Access Criteria: To be defined

Locations

SE (1)