A Pilot Study Comparing the Efficacy of Four Different Methods of Performing External Aortic Compression in Healthy Women After Caesarean Section

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.