Inferior Vena Cava Diameter and Postpartum Hemorrhage

• ClinicalTrials.gov Identifier: NCT03732079
• Recruitment Status: Unknown
• First Posted: November 6, 2018
• Last Update Posted: November 6, 2018
• Sponsor: HaEmek Medical Center, Israel
• Information provided by (Responsible Party): HaEmek Medical Center, Israel

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Other Immediate Postpartum Hemorrhage, With Delivery	Diagnostic Test: Ultrasound

Study Design

• Study Type: Observational
• Estimated Enrollment: 108 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Correlation Between Inferior Vena Caval Diameter and the Volume of Postpartum Blood Loss
• Estimated Study Start Date: November 10, 2018
• Estimated Primary Completion Date: April 30, 2019
• Estimated Study Completion Date: April 30, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Research group; Women with early postpartum hemorrhage.	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.
Control group; Postpartum women without abnormal bleeding.	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.

Outcome Measures

Primary Outcome Measures :

1. To examine the correlation between IVC diameter and the volume of postpartum blood loss. [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. 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. [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: postpartum women
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Postpartum women.

Criteria

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

Contacts and Locations

Contacts

Contact: Manal Massalha, MD; 0506415166; manal.massalha@clalit.org.il

Contact: Raed Salim, MD; salim_ra@clalit.org.il

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

• Principal Investigator: Manal Massalha, Massalha; Emek Medical Center

More Information

Publications of Results:

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

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.

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.

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.

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.

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.

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 2016 Feb 19.

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.

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.

• Responsible Party: HaEmek Medical Center, Israel
• ClinicalTrials.gov Identifier: NCT03732079
• Other Study ID Numbers: HaEmek
• First Posted: November 6, 2018
• Last Update Posted: November 6, 2018
• Last Verified: November 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by HaEmek Medical Center, Israel:

Inferior Vena Cava Diameter

Additional relevant MeSH terms:

Postpartum Hemorrhage; Hemorrhage; Pathologic Processes; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage