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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03732079
Other study ID # HaEmek
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 10, 2018
Est. completion date April 30, 2019

Study information

Verified date November 2018
Source HaEmek Medical Center, Israel
Contact Manal Massalha, MD
Phone 0506415166
Email manal.massalha@clalit.org.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Excessive bleeding after normal birth or cesarean section is defined as blood loss of 1000 mL or more (clinically estimated) within 24 hours after birth. It occurs in about 5% among postpartum women. Postpartum hemorrhage is a leading cause of morbidity and mortality among women giving birth. Postpartum hemorrhage may lead to hemorrhagic shock, renal failure, respiratory failure, need for surgical intervention, blood transfusion and hysterectomy.

The cornerstone of effective treatment is rapid diagnosis and intervention in time. However, in a number of cases there is an underestimation of the volume of blood loss which may lead to delay in diagnosis and treatment. The consequences are even graver in women who delivered by a cesarean section, since unlike a normal birth in which the bleeding is external and visible, the bleeding is usually intra-abdominal, and so the delay in diagnosis may be even longer.

The Inferior Vena Cava (IVC) is a flexible blood vessel sensitive to intravascular blood volume, and its diameter varies accordingly. Its diameter reflects the pressure in the right atrium, which is a measure of the cardiac preload. A number of studies have shown that the IVC diameter changes, before the variations in vital and clinical signs.

Recently, IVC diameter has been assessed as an assessment of intravenous fluid balance in hemodynamically stable patients with a risk of sub-volume shock. The authors concluded that the IVC measurement is a good noninvasive method, compared to catheter insertion into the right atrium, and it is available as a bedside procedure.

In obstetrics the use of IVC to determine blood loos was not widely examined and there is no information regarding the use of IVC diameter as a predictor or as a detection method of postpartum bleeding.

In this study the investigators aim to examine the correlation between IVC diameter and the volume of postpartum blood loss.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 108
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women over the age of 18 after birth

- Single pregnancy

- Vaginal birth

- Term pregnancy (gestational age between week 37-42)

- The newborn is appropriate for gestational age (10-90 percentile)

Exclusion Criteria:

- Gestational or pre-pregnancy hypertension

- Heart, liver, or chronic kidney disease

- Women who delivered newborn with major malformation

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasound
Ultrasound to measure the IVC diameter. The IVC diameter will be measured in the inspirium and the expirium, and the collapsibility index will be recorded.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

References & Publications (9)

Byeon K, Choi JO, Yang JH, Sung J, Park SW, Oh JK, Hong KP. The response of the vena cava to abdominal breathing. J Altern Complement Med. 2012 Feb;18(2):153-7. doi: 10.1089/acm.2010.0656. — View Citation

Callaghan WM, Kuklina EV, Berg CJ. Trends in postpartum hemorrhage: United States, 1994-2006. Am J Obstet Gynecol. 2010 Apr;202(4):353.e1-6. doi: 10.1016/j.ajog.2010.01.011. — View Citation

Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351. — View Citation

Grant E, Rendano F, Sevinc E, Gammelgaard J, Holm HH, Grønvall S. Normal inferior vena cava: caliber changes observed by dynamic ultrasound. AJR Am J Roentgenol. 1980 Aug;135(2):335-8. Review. — View Citation

Hernandez CA, Reed KL, Juneman EB, Cohen WR. Changes in Sonographically Measured Inferior Vena Caval Diameter in Response to Fluid Loading in Term Pregnancy. J Ultrasound Med. 2016 Feb;35(2):389-94. doi: 10.7863/ultra.15.04036. Epub 2016 Jan 18. — View Citation

Kusaba T, Yamaguchi K, Oda H, Harada T. Echography of inferior vena cava for estimating fluid removed from patients undergoing hemodialysis. Nihon Jinzo Gakkai Shi. 1994 Aug;36(8):914-20. — View Citation

Lyon M, Blaivas M, Brannam L. Sonographic measurement of the inferior vena cava as a marker of blood loss. Am J Emerg Med. 2005 Jan;23(1):45-50. — View Citation

Rahman NH, Ahmad R, Kareem MM, Mohammed MI. Ultrasonographic assessment of inferior vena cava/abdominal aorta diameter index: a new approach of assessing hypovolemic shock class 1. Int J Emerg Med. 2016 Dec;9(1):8. doi: 10.1186/s12245-016-0101-z. Epub 201 — View Citation

Ryo E, Unno N, Hagino D, Kozuma S, Nagasaka T, Taketani Y. Inferior vena cava diameter and the risk of pregnancy-induced hypertension and fetal compromise. Int J Gynaecol Obstet. 1999 May;65(2):143-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To examine the correlation between IVC diameter and the volume of postpartum blood loss. 6 months
Secondary To create a normogram of IVC diameter in postpartum women and to check whether there is a cutt-of value that appears before the onset of clinical signs of blood loss. 6 months