Other Immediate Postpartum Hemorrhage, With DeliveryNCT03732079
Inferior Vena Cava Diameter and Postpartum Hemorrhage
An observational study of Other Immediate Postpartum Hemorrhage, With Delivery, run by HaEmek Medical Center, Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Other Immediate Postpartum Hemorrhage, With Delivery
- What is being tested?
- Ultrasound
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postpartum women.
Who may be able to join
- 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)
Who cannot join
- Gestational or pre-pregnancy hypertension
- Heart, liver, or chronic kidney disease
- Women who delivered newborn with major malformation
Trial locations and contacts
No sites are listed yet.
Raed Salim, MD contact
About this study
Official title: The Correlation Between Inferior Vena Caval Diameter and the Volume of Postpartum Blood Loss
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.
Read more
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.
- Being tested
- Ultrasound
- Keywords
- Inferior Vena Cava Diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Research group | Women with early postpartum hemorrhage. Receives: Diagnostic Test: Ultrasound | |
| Control group | Postpartum women without abnormal bleeding. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the correlation between IVC diameter and the volume of postpartum blood loss.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start10 Nov 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Other Immediate Postpartum Hemorrhage, With DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manal Massalha, Massalha, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732079
- Sponsor's protocol ID
- HaEmek
- Status last verified
- Nov 2018
- First submitted
- 4 Nov 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 28937571Callaghan 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 20350642Byeon 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 22339104Grant 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 6773338Kusaba 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 7933667Lyon 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 15672337Rahman 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 26894896Hernandez 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 26782160Ryo 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Inferior Vena Caval Diameter and the Volume of Postpartum Blood Loss
- ClinicalTrials.gov ID
- NCT03732079
- Acronym / sponsor ID
- HaEmek
- Keywords
- Inferior Vena Cava Diameter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 10 Nov 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research group | – | Diagnostic Test: UltrasoundWomen with early postpartum hemorrhage. |
| Control group | – | Diagnostic Test: UltrasoundPostpartum women without abnormal bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postpartum women.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Gestational or pre-pregnancy hypertension
- Heart, liver, or chronic kidney disease
- Women who delivered newborn with major malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound to measure the IVC diameter. The IVC diameter will be measured in the inspirium and the expirium, and the collapsibility index will be recorded. | Diagnostic test | Control group, Research group |
Primary outcome
To examine the correlation between IVC diameter and the volume of postpartum blood loss.
Time frame: 6 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Results publication: PubMed 28937571Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
- Results publication: PubMed 20350642Callaghan 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.
- Results publication: PubMed 22339104Byeon 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.
- Results publication: PubMed 6773338Grant 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.
- Results publication: PubMed 7933667Kusaba 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.
- Results publication: PubMed 15672337Lyon 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.
- Results publication: PubMed 26894896Rahman 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.
- Results publication: PubMed 26782160Hernandez 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.
- Results publication: PubMed 10405058Ryo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raed Salim, MD contact
Manal Massalha, Massalha principal investigator
Emek Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Other Immediate Postpartum Hemorrhage, With Delivery, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Massalha, MD (0506415166, manal.massalha@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the correlation between IVC diameter and the volume of postpartum blood loss. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03732079, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.