## Protocol Section
### Identification Module
**NCT ID:** NCT03732079

**Brief Title:** Inferior Vena Cava Diameter and Postpartum Hemorrhage

**Official Title:** The Correlation Between Inferior Vena Caval Diameter and the Volume of Postpartum Blood Loss

#### Organization Study ID Info
**ID:** HaEmek
#### Organization
**Class:** OTHER
**Full Name:** HaEmek Medical Center, Israel
### Status Module
#### Completion Date
**Date:** 2019-04-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2018-11-06

**Type:** ACTUAL

**Last Update Submit Date:** 2018-11-05

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-11-10

**Type:** ESTIMATED

**Status Verified Date:** 2018-11

#### Study First Post Date
**Date:** 2018-11-06
**Type:** ACTUAL
**Study First Submit Date:** 2018-11-04
**Study First Submit QC Date:** 2018-11-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** HaEmek Medical Center, Israel

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Other Immediate Postpartum Hemorrhage, With Delivery

**Keywords:**

- Inferior Vena Cava Diameter

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 108

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Women with early postpartum hemorrhage.

**Intervention Names:**

- Diagnostic Test: Ultrasound

**Label:** Research group

#### Arm Group 2

**Description:** Postpartum women without abnormal bleeding.

**Intervention Names:**

- Diagnostic Test: Ultrasound

**Label:** Control group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group

- Research group

**Description:** 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.

**Name:** Ultrasound

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Measure:** To examine the correlation between IVC diameter and the volume of postpartum blood loss.

**Time Frame:** 6 months

#### Secondary Outcomes

**Measure:** 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 Module

**Eligibility 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

**Gender Based:** True

**Gender Description:** postpartum women

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Postpartum women.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** manal.massalha@clalit.org.il

**Name:** Manal Massalha, MD

**Phone:** 0506415166

**Role:** CONTACT

**Contact 2:**

**Email:** salim_ra@clalit.org.il

**Name:** Raed Salim, MD

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Emek Medical Center

**Name:** Manal Massalha, Massalha

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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.

**PMID:** 28937571

**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.

**PMID:** 20350642

**Citation:** 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

**Citation:** 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

**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.

**PMID:** 7933667

**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. doi: 10.1016/j.ajem.2004.01.004.

**PMID:** 15672337

**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 2016 Feb 19.

**PMID:** 26894896

**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.

**PMID:** 26782160

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

**PMID:** 10405058

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011644

- Term: Puerperal Disorders

- ID: D000014592

- Term: Uterine Hemorrhage

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M9559

- Name: Postpartum Hemorrhage

- Relevance: HIGH

- As Found: Postpartum Hemorrhage

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14499

- Name: Puerperal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17340

- Name: Uterine Hemorrhage

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006473

- Term: Postpartum Hemorrhage

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T204

- Name: Kava

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
