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Investigating the Association of Shock Index and Hemoglobin Variation With Postpartum Hemorrhage After Vaginal Deliveries

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ClinicalTrials.gov Identifier: NCT03432767
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary:

Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity, and is most commonly caused by poor uterine tone after delivery of the baby and placenta. Currently, a lack of early identification of PPH also results in delayed treatment, with an increase in morbidity. The investigators propose that 2 non-invasive methods may provide monitoring for early and accurate detection of PPH. These methods include shock index (SI) and continuous hemoglobin (Hb) monitoring. SI is defined as heart rate divided by systolic blood pressure, and can be used as a marker to predict the severity of hypovolemic shock. Continuous Hb monitoring can now be done using a non-invasive probe that is placed on the patient's finger. It provides real-time Hb values, rather than having to draw blood and wait for a lab test.

The investigators hypothesize that SI will have a stronger association with postpartum blood loss than Hb variation.


Condition or disease Intervention/treatment
Postpartum Hemorrhage Device: Non-invasive hemoglobin monitor

Detailed Description:

The investigators believe that trends in patient-specific SI combined with continuous SpHb monitoring, will be useful to identify PPH and the immediate need for pharmacotherapy, as well as the need for transfusion in obstetric patients undergoing vaginal deliveries. The investigators expect shock index to increase and SpHb levels to decrease with increasing blood loss after delivery. The compensatory hemodynamic response may start early, however, Hb variation may be delayed unless the patient is transfused with crystalloids. Also autotransfusion after delivery may influence these measures. It is unknown which one of the two indicators, SI or SpHb, has a stronger association with blood loss after vaginal delivery.

It is already established that both SI and SpHb are independent, clinically useful markers indicating significant blood loss in elective cesarean delivery and trauma. This study would assess their utility in the recognition and management of obstetric hemorrhage following normal vaginal delivery, where early recognition and resuscitation reduces the risk of progressing to hemorrhagic shock, disseminated intravascular coagulation and death.


Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Association of Shock Index and Hemoglobin Variation With Postpartum Hemorrhage After Vaginal Deliveries: A Prospective Cohort Study
Actual Study Start Date : February 16, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Women having a vaginal delivery
A non-invasive hemoglobin monitor will be attached to the patient's finger and kept on for 2 hours after she delivers. Heart rate and blood pressure will be measured every 10 minutes.
Device: Non-invasive hemoglobin monitor



Primary Outcome Measures :
  1. Shock index values [ Time Frame: 2 hours ]
    Calculated shock index (heart rate/systolic blood pressure) every 10 minutes from delivery until 2 hours postpartum.

  2. Hemoglobin values [ Time Frame: 2 hours ]
    Spectrophotometric hemoglobin values from a non-invasive monitor, recorded every 10 minutes from delivery until 2 hours postpartum.


Secondary Outcome Measures :
  1. Estimated blood loss (calculated) [ Time Frame: 24 hours ]
    Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 24 hours after the cesarean section.

  2. Estimated blood loss (weight) [ Time Frame: 2 hours ]
    Blood loss will be calculated by weighing the pads placed under the patient following delivery.

  3. Administration of uterotonic medication [ Time Frame: 24 hours ]
    Any oxytocin, ergonovine, carboprost, misoprostol administered following delivery

  4. Blood transfusion [ Time Frame: 24 hours ]
    The need for any transfusion of blood product following delivery.

  5. Surgical interventions [ Time Frame: 24 hours ]
    The need for manual placental removal, laceration/episiotomy repair, Bakri balloon, uterine artery ligation, hysterectomy, uterine artery/internal iliac artery embolization

  6. ICU admission [ Time Frame: 24 hours ]
    The need for admission to ICU following delivery



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Women having an expected vaginal delivery
Criteria

Inclusion Criteria:

  • patients who give written consent to participate in this study
  • all term laboring patients including spontaneous and induced labor (gestational age >37 weeks) undergoing spontaneous vaginal delivery or instrumental delivery

Exclusion criteria

  • patients who refuse to give written informed consent
  • patients with cardiac rhythm abnormalities or cardiac diseases
  • patients undergoing elective/emergency CD
  • patients with jaundice
  • patients with abnormal Hb-->Such as Sickle cell disease and Thalassemia
  • patients with peripheral vascular disease
  • patients with hypertension and preeclampsia
  • patients on medications affecting blood pressure such as anti hypertensives (including Magnesium Sulphate), and those affecting HR (including beta blockers)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432767


Contacts
Contact: Mrinalini Balki, MD 416-586-4800 ext 5270 mrinalini.balki@uhn.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1X5
Contact: Mrinalini Balki, MD    416-586-4800 ext 5270    mrinalini.balki@uhn.ca   
Sub-Investigator: Jose Carvalho, MD         
Sub-Investigator: Kristi Downey, MSc         
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Mrinalini Balki, MD MOUNT SINAI HOSPITAL

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT03432767     History of Changes
Other Study ID Numbers: 18-03
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
pregnancy
postpartum hemorrhage
vaginal delivery
shock index
hemoglobin

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage