Inferior Vena Cava Diameter and Postpartum Hemorrhage

• Conditions: Other Immediate Postpartum Hemorrhage, With Delivery
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT03732079
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-04
• Study First Submitted QC: 2018-11-05
• Last Update Submitted: 2018-11-05
• Study First Posted: 2018-11-06
• Last Update Posted: 2018-11-06
• Study Start: 2018-11-10
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 108

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Research group	Ultrasound	Women with early postpartum hemorrhage.
Control group	Ultrasound	Postpartum women without abnormal bleeding.

Primary Outcome Measures

Name	Time	Method
To examine the correlation between IVC diameter and the volume of postpartum blood loss.	6 months

Secondary Outcome Measures

Name	Time	Method
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