Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06157307 |
| Other study ID # |
AAronsson |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2023 |
| Est. completion date |
March 8, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Region Stockholm |
| Contact |
Charlotte Lindblad Wollmann, MD, PhD |
| Phone |
+46707912068 |
| Email |
charlotte.lindblad-wollmann[@]regionstockholm.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
This is a pilot study comparing the efficacy of four different methods of performing external
aortic compression in healthy women after caesarean section. In patients with severe
postpartum hemorrhage (PPH) external compression of the abdominal aorta, may temporize the
bleeding and thus reduce morbidity and mortality. PPH is a serious obstetric emergency and
the single most important cause of maternal mortality globally The most common causes of PPH
are uterine atony followed by placental disorders, retained placenta and membranes, birth
trauma and coagulation defects. The World Health Organization defines PPH as the blood loss
of ≥500 mL within the first 24 hours after delivery. Severe PPH is defined ≥1000 mL. The
majority of PPH occur within 4 hours. The incidence of severe PPH is reported to vary between
1 - 5% of all births, depending upon the diagnostic criteria applied. Early diagnosis and
management are critical in preventing maternal deaths. Manual external aortic compression is
a technique that can be applied immediately to reduce bleeding from the uterus or birth canal
by reducing its blood supply as aorta is compressed against the column through the abdominal
wall.
Objectives and hypotheses of the clinical investigation In this pilot study the primary
objective is cessation of femoral artery blood flow when applying external aortic compression
in women immediately after they have given birth by caesarean section with the fingertips,
the fist placed longitudinally, with the fist placed transversally compared with the padded
fist protector At each of the four methods of compressing aorta, the cessation of the flow in
the femoral artery and hemodynamic parameters will be registered. The primary endpoint is the
cessation of pulsation in the femoral artery measured by ultrasound. Reduction of the femoral
artery blood flow can be assumed to be a surrogate marker for the reduction of blood flow in
the aorta and thus to areas below the compressed aorta.
Secondary objective is to evaluate if there a difference in the investigator experience
between the four different methods. The ExAC fist protector has been developed to facilitate
the manual external aortic compression used to temporarily reduce or stop postpartum
bleeding. The fist protector provides a soft padding of the fist that allows any unevenness
to be reduced when aorta is compressed between the boney surface of fist and the spinal
column and facilitates herby a complete compression. The fist protector will be put on the
fist of the researcher who will apply external aortic compression. The researcher will
otherwise do the maneuver as usual.The investigator will evaluate if the fist protector makes
it easier to perform the maneuver. The participant will evaluate if the fist protector leads
to less discomfort
In this pilot study the main research questions are as follows:
Is there a difference in the efficacy, defined as cessation of blood flow in the femoral
artery measured by ultrasound doppler, when applying external aortic compression with the
fingertips, the fist placed longitudinally, with the fist placed transversally Sample size
calculation and justification Six healthy, female participants will be included in the study.
There has been no sample size calculation. This is a small pilot study, and the device is to
be modified prior to further investigation.
PERFORMANCE AND SAFETY VARIABLES:
The heart rate (HR) and cardiac rhythm, blood pressure (BP) and oxygen saturation will be
registered, and the femoral artery identified at the level just below the inguinal ligament
using the ultrasound scanning. The sequence of aortic compression at the level of umbilicus
will be applied for maximum 5 seconds of complete occlusion in the following manner:
1. Performed with the fingertips.
2. Performed with with the fist placed longitudinally.
3. Performed with the fist placed transversally.
4. Performed with ExAC compression fist protector At each of the four methods of
compressing aorta the flow in the femoral artery and hemodynamic parameters will be
registered Anticipated adverse device effects External aortic compression is associated
with pain and discomfort. To reduce the discomfort for the participants it is an
advantage that the participant has a spinal anesthesia. For this study we have chosen to
include women after c-section when they still have a spinal anesthesia.
Anticipated adverse events of the investigations include:
- Discomfort/pain.
- Slightly increase in blood pressure induced by aortic compression. Six healthy women who
have undergone uncomplicated caesarean sections are selected as subjects because the
discomfort and inconvenience for these women will be less prominent compared to recently
vaginally delivered women. Immediately after the operation has been completed, the women
remain on the operating table in the right position and it is easy carry out the study.
Participants Inclusion criteria
- Normal pregnancy
- No ongoing medication
- Age 18 - 35
- BMI 18.5-30
- Proficient Swedish language skills
- Uncomplicated caesarean sectio Exclusion criteria
- Tobacco/Nicotine use
- Any ongoing medication
- Any chronic disease except seasonal allergy
- Previous abdominal surgery
- Complicated caesarean section The researcher team consists of 3 people. A principal
investigator and two researchers from Karolinska University Hospital Solna.
One researcher will perform the aortic compression, one will evaluate the flow in the femoral
artery using ultrasound scanning. The third researcher will help the principal investigator
to obtain the measurements.
Recruitment and screening The parturient will be recruited among patients who have a planned
caesarean section at Karolinska University Hospital Solna. The patient will get verbal and
written information about the study and will have the opportunity to ask questions. After the
participant has agreed to participate, she will be asked to sign and date an informed
consent. Enrolled to the study will be after the caesarean sectio. Preparation of subject and
continuous safety monitoring of subject The infant can stay on the mothers chest after the
caesarean section and this will be preferred. By the mothers request the baby will be taken
care of by the father or the midwife.
Following measurements will be monitored during the investigation:
- Pulse-oximeter
- Non-invasive blood pressure (NIBP)
- Electrocardiogram (ECG)
- Heart rate
- Flow in the femoral artery Baseline measurements The investigator registers heart rate
(HR) and cardiac rhythm, blood pressure (BP) and oxygen saturation. The coinvestigator
will identify the femoral artery at the level just below the inguinal ligament using the
ultrasound scanning. The ultrasound sequences will be recorded for each individual and
stored. Experimental measurements Once the baseline measurements are complete, the
participant will rest for 2 minutes before the actual experiment commences. The sequence
of aortic compression will be applied in the following manner for maximum 5 seconds of
complete occlusion. The compressions will be done at the level of umbilicus.
1. Performed with the fingertips.
2. Minimum 2 minutes of no occlusion.
3. Performed with the fist placed longitudinally.
4. Minimum 2 minutes of no occlusion.
5. Performed with the fist placed transversally.
6. Minimum 2 minutes of no occlusion.
7. Performed with ExAC compression fist protector Variables that will be registered
1. Baseline measurements
1. Pulse-oximeter
2. Non-invasive blood pressure (NIBP)
3. Electrocardiograph (ECG)
4. Heart rate In case of failure to compress the aorta by closed fist or ExAC
fist protector a maximum of three new attempts with repositioning will be
done. A failure of occlusion of the aorta will be registered. Baseline
measurements (blood pressure, heart rate, and oxygen saturation) will be
re-registered between the three experimental maneuvers. This will ensure
correct baseline measurements for each maneuver. Follow up After the study,
the subjects will be observed for 30 minutes. All subjects will be informed to
contact the primary investigator (mobile phone number provided) in case of any
concerns related to the investigation for the first 7 days. Data Collection
The clinical investigation data will be collected on paper CRF completed by
one of the researchers Participant Records and Source Data The data will be
recorded directly in the CRF, which will then be considered as source data.
The origin of source data in the investigation will be further specified in a
separate document . It is the responsibility of the investigation site to
record essential information in the medical records in accordance with
national regulations and requirements:
- Study code
- Participant ID code
- That informed consent for participating in the study was obtained
- All visits during the investigation period
- All adverse events (AE)/adverse device events (ADE)s
- Treatments and medications The Investigator is responsible for ensuring the accuracy,
completeness, legibility, and timeliness of the data recorded.
