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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432767
• Other study ID #: 18-03
• Status: Completed
• Start date: February 16, 2016
• Est. completion date: January 11, 2019

Study information

• Verified date: April 2019
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 11, 2019
• Est. primary completion date: January 10, 2019
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Device:
• Non-invasive hemoglobin monitor

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shock index values	Calculated shock index (heart rate/systolic blood pressure) every 10 minutes from delivery until 2 hours postpartum.	2 hours
Primary	Hemoglobin values	Spectrophotometric hemoglobin values from a non-invasive monitor, recorded every 10 minutes from delivery until 2 hours postpartum.	2 hours
Secondary	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
Secondary	Estimated blood loss (weight)	Blood loss will be calculated by weighing the pads placed under the patient following delivery.	2 hours
Secondary	Administration of uterotonic medication	Any oxytocin, ergonovine, carboprost, misoprostol administered following delivery	24 hours
Secondary	Blood transfusion	The need for any transfusion of blood product following delivery.	24 hours
Secondary	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
Secondary	ICU admission	The need for admission to ICU following delivery	24 hours