Inferior Vena Cava Diameter and Postpartum Hemorrhage

NCT03732079 | Unknown DMC FDA Device

• 1 other identifier: HaEmek
• Study Type: observational
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Other Immediate Postpartum Hemorrhage, With Delivery

Keywords

Inferior Vena Cava Diameter

Outcome Measures

Primary Outcomes (1)

• To examine the correlation between IVC diameter and the volume of postpartum blood loss.

  6 months

Secondary Outcomes (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.

  6 months

Study Arms (2)

Research group

Women with early postpartum hemorrhage.

Diagnostic Test: Ultrasound

Control group

Postpartum women without abnormal bleeding.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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; Research group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: postpartum women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postpartum women.

You may qualify if:

• 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)

You may not qualify if:

• Gestational or pre-pregnancy hypertension
• Heart, liver, or chronic kidney disease
• Women who delivered newborn with major malformation

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Related Publications (9)

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

  PMID: 28937571 RESULT

• 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.

  PMID: 20350642 RESULT

• 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.

  PMID: 22339104 RESULT

• Grant E, Rendano F, Sevinc E, Gammelgaard J, Holm HH, Gronvall S. Normal inferior vena cava: caliber changes observed by dynamic ultrasound. AJR Am J Roentgenol. 1980 Aug;135(2):335-8. doi: 10.2214/ajr.135.2.335.

  PMID: 6773338 RESULT

• 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.

  PMID: 7933667 RESULT

• 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. doi: 10.1016/j.ajem.2004.01.004.

  PMID: 15672337 RESULT

• 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.

  PMID: 26894896 RESULT

• 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.

  PMID: 26782160 RESULT

• 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. doi: 10.1016/s0020-7292(99)00027-2.

  PMID: 10405058 RESULT

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Manal Massalha, Massalha

  Emek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal Massalha, MD

CONTACT

0506415166; manal.massalha@clalit.org.il

Raed Salim, MD

CONTACT

salim_ra@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 6, 2018
• Study Start: November 10, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: November 6, 2018

Record last verified: 2018-11