ClinicalTrials.gg
Status unknownNCT03732079Updated Nov 6, 2018

Inferior Vena Cava Diameter and Postpartum Hemorrhage

An observational study in Other Immediate Postpartum Hemorrhage, With Delivery, sponsored by HaEmek Medical Center, Israel. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-06.

Sponsored by HaEmek Medical Center, Israel · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
108
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Other Immediate Postpartum Hemorrhage, With Delivery

Keywords

  • Inferior Vena Cava Diameter
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In context

Lead sponsor

HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Postpartum women.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
108 participants (estimated)
Patient registry
No

Groups and cohorts

  • Research group

    Women with early postpartum hemorrhage.

    Diagnostic Test: Ultrasound

  • Control group

    Postpartum women without abnormal bleeding.

    Diagnostic Test: Ultrasound

Interventions

  • Diagnostic testUltrasound

    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.

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What researchers measure

Primary outcomes

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

    Time frame: 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.

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351. PubMed 28937571 ↗
  • 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. PubMed 20350642 ↗
  • 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. PubMed 22339104 ↗
  • 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. PubMed 6773338 ↗
  • 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. PubMed 7933667 ↗
  • 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. PubMed 15672337 ↗
  • 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. PubMed 26894896 ↗
  • 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. PubMed 26782160 ↗
  • 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. PubMed 10405058 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03732079
Responsible party
Sponsor
First posted
Nov 6, 2018
Start date
Nov 10, 2018 (estimated)
Primary completion
Apr 30, 2019 (estimated)
Completion
Apr 30, 2019 (estimated)
Last update
Nov 6, 2018

Study contacts

Manal Massalha, MD
Contact
manal.massalha@clalit.org.il
0506415166
Raed Salim, MD
Contact
salim_ra@clalit.org.il
Manal Massalha, Massalha
principal investigator · Emek Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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