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

Investigating the Association of Shock Index and Hemoglobin Variation With Postpartum Hemorrhage After Vaginal Deliveries: A Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: 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
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women having an expected vaginal delivery

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shock index values	Calculated shock index (heart rate/systolic blood pressure) every 10 minutes from delivery until 2 hours postpartum.	2 hours
Hemoglobin values	Spectrophotometric hemoglobin values from a non-invasive monitor, recorded every 10 minutes from delivery until 2 hours postpartum.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss (calculated)	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.	24 hours
Estimated blood loss (weight)	Blood loss will be calculated by weighing the pads placed under the patient following delivery.	2 hours
Administration of uterotonic medication	Any oxytocin, ergonovine, carboprost, misoprostol administered following delivery	24 hours
Blood transfusion	The need for any transfusion of blood product following delivery.	24 hours
Surgical interventions	The need for manual placental removal, laceration/episiotomy repair, Bakri balloon, uterine artery ligation, hysterectomy, uterine artery/internal iliac artery embolization	24 hours
ICU admission	The need for admission to ICU following delivery	24 hours

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2016
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): January 11, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 13, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: hemoglobin; pregnancy; postpartum hemorrhage; vaginal delivery; shock index
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: 18-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No