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

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Device: Non-invasive hemoglobin monitor

• Registration Number: NCT03432767
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-02-16
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-14
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-13
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women having a vaginal delivery	Non-invasive hemoglobin monitor	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada