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

NCT03432767 | Completed

• 1 other identifier: 18-03
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Keywords

pregnancy; postpartum hemorrhage; vaginal delivery; shock index; hemoglobin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Estimated blood loss (calculated)

  24 hours

• Estimated blood loss (weight)

  2 hours

• Administration of uterotonic medication

  24 hours

• Blood transfusion

  24 hours

• Surgical interventions

  24 hours

Study Arms (1)

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

Interventions

Non-invasive hemoglobin monitor DEVICE

Women having a vaginal delivery

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women having an expected vaginal delivery

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 14, 2018
• Study Start: February 16, 2016
• Primary Completion: January 10, 2019
• Study Completion: January 11, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)