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Aortic Compression Trial to Reduce Blood Loss at Cesarean Section (ACT)

Primary Purpose

Post Partum Hemorrhage, Cesarean Section Complications, Anemia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
External aortic compression
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Hemorrhage focused on measuring Aortic compression, Post partum hemorrhage, Anemia, Cesarean section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: All women undergoing elective cesarean section. -

Exclusion Criteria: None.

-

Sites / Locations

  • Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Routine external aortic compression

No external aortic compression

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Calculated peripartum hemorrhage
Calculated estimated blood loss greater than 1000 ml or a red-cell transfusion within 2 days 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.

Secondary Outcome Measures

Peripartum hemorrhage (g)
Blood loss at surgery, or shortly after, of 1000 g or more
Hemoglobin and EVF change
Difference between prepoerative (0-48 h) and postpartum (24-48 h) B-Hemoglobin and erythrocyte volume fraction.
Transfusion
Transfusion of blood products (erythrocyte/whole blood/plasma)
Maternal death
Death of patient after cesarean section
Severe maternal morbidity
Composite outcome including hysterectomy, intensive care, ischemic heart disease/heart failure, pulmonary edema, venous thromboembolism, cerebral insult.
Duration of surgery
Time from incision start to skin closure stop (minutes)
Duration of hospital stay
Time from incision start to discharge from the hospital (hours)

Full Information

First Posted
March 28, 2022
Last Updated
February 16, 2023
Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT05312658
Brief Title
Aortic Compression Trial to Reduce Blood Loss at Cesarean Section
Acronym
ACT
Official Title
Aortic Compression Trial - a Randomized Controlled Trial to Reduce Blood Loss at Cesarean Section (ACT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The ACT trial investigates if manual external aortic compression is an effective and acceptable preventive measure to reduce severe postpartum hemorrhage (PPH) in cesarean section. Severe PPH is a maternal blood loss ≥1000 ml at childbirth. Severe PPH causes maternal mortality and morbidity. Severe PPH is more common in cesarean sections than in vaginal births. Routine oxytocin intravenous injection and swift placenta delivery through cord traction is recommended to prevent PPH. Manual external aortic compression is used in other obstetric situations to temporise blood loss and could be used prophylactically during cesarean section until bleeding control is attained. The Cochrane Library stated in 2020 that mechanical methods for the prevention and treatment of PPH, including aortic compression, urgently need scientific evaluation. The ACT trial is a multicenter randomised controlled trial including aiming to include 2232 patients in four Swedish regions running over two years. The trial includes patients undergoing cesarean section. The intervention is routine manual external aortic compression immediately after the baby is delivered and the comparison is no routine external aortic compression. The primary outcome is proportion of patients with a calculated blood loss ≥1000 ml perioperatively or blood transfusion within 2 days. Secondary outcomes are mortality, serious morbidity (for example hysterectomy), surgery duration, hospital stay duration, patient experience, neonatal outcomes, and postnatal maternal health (depression, breastfeeding). If proven effective and acceptable, external aortic compression is a simple and low-cost measure that could reduce severe PPH and improve obstetric care worldwide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage, Cesarean Section Complications, Anemia
Keywords
Aortic compression, Post partum hemorrhage, Anemia, Cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine external aortic compression
Arm Type
Experimental
Arm Description
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.
Arm Title
No external aortic compression
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
External aortic compression
Intervention Description
External aortic compression by assistant in cesarean section.
Primary Outcome Measure Information:
Title
Calculated peripartum hemorrhage
Description
Calculated estimated blood loss greater than 1000 ml or a red-cell transfusion within 2 days 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.
Time Frame
0-2 days postpartum
Secondary Outcome Measure Information:
Title
Peripartum hemorrhage (g)
Description
Blood loss at surgery, or shortly after, of 1000 g or more
Time Frame
0-6 hours postpartum
Title
Hemoglobin and EVF change
Description
Difference between prepoerative (0-48 h) and postpartum (24-48 h) B-Hemoglobin and erythrocyte volume fraction.
Time Frame
0-3 days postpartum
Title
Transfusion
Description
Transfusion of blood products (erythrocyte/whole blood/plasma)
Time Frame
0-7 days postpartum
Title
Maternal death
Description
Death of patient after cesarean section
Time Frame
0-42 days postpartum
Title
Severe maternal morbidity
Description
Composite outcome including hysterectomy, intensive care, ischemic heart disease/heart failure, pulmonary edema, venous thromboembolism, cerebral insult.
Time Frame
0-42 days postpartum
Title
Duration of surgery
Description
Time from incision start to skin closure stop (minutes)
Time Frame
0-1 day postpartum
Title
Duration of hospital stay
Description
Time from incision start to discharge from the hospital (hours)
Time Frame
0-42 days postpartum
Other Pre-specified Outcome Measures:
Title
Patient experience of the operation
Description
Pain, nausea, breathing, overall experience rated with numeric rating scale 0-10
Time Frame
1-3 days postpartum
Title
Postpartum depression
Description
Edinburgh Postnatal Depression Scale
Time Frame
6-8 weeks postpartum
Title
Breastfeeding
Description
Breastfeeding Self-Efficacy Scale-Short Form
Time Frame
6-8 weeks postpartum
Title
Uterine wall defect
Description
Ultrasound evaluation of the anterior uterine wall, measuring any niche and wall thickness.
Time Frame
6 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Planned cesarean delivery, live fetus/fetuses if multiple pregnancy, gestational week 34+0 or more, signed informed consent. Exclusion Criteria: Preoperative B-Hemoglobin <100 g/l, planned hysterectomy in the same procedure as the planned cesarean delivery, other condition as deemed by attending surgeon.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Brismar Wendel, MD, PhD
Organizational Affiliation
Danderyd Hospital Karolinska Institutet, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized data will be shared with other researchers for a joint publication or for systematic review purposes with due citation.
IPD Sharing Time Frame
From one year after the trial is finalized with no upper limit.
IPD Sharing Access Criteria
To be defined
Citations:
PubMed Identifier
32609374
Citation
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.
Results Reference
background
Links:
URL
https://www.snaks.se/act/
Description
Swedish network for national clinical studies in Obstetrics and Gynecology, information about ACT in Swedish

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Aortic Compression Trial to Reduce Blood Loss at Cesarean Section

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