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NCT Number: NCT03432767

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

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.

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Key information

Conditions

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

Age range

16 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-invasive hemoglobin monitor

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 14, 2018
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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