Pulse Pressure and Post-epidural Fetal Heart Rate Changes

NCT02565485 | Completed Results

• 1 other identifier: IRB15-00366
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural anesthesia, the most common method of pain control in labor, can contribute to alterations in maternal blood pressure and/or fetal heart rate changes. As a result, the administration of an IV fluid bolus ("preload") is standard prior to epidural placement. However, the optimal volume of preload is unknown and no clinical trials have evaluated a risk-factor based approach to dosing. Studies in the critical care, trauma, and obstetric literature have suggested that a narrow pulse pressure (difference between systolic and diastolic blood pressures) is a marker of reduced intravascular volume status and may identify women at a higher risk for new onset fetal heart rate changes after epidural placement. Therefore, the purpose of this study is to assess if an increased IV fluid preload bolus among women with a narrow pulse pressure reduces the risk of new onset fetal heart rate changes after epidural placement.

Conditions

Fetus or Neonate Affected by Maternal Epidural Anesthesia During Labor and Delivery

Keywords

pulse pressure; fetal heart rate; epidural analgesia; hypotension; preload; fluid bolus; central hypovolemia

Outcome Measures

Primary Outcomes (1)

• Incidence of New-onset Category II or III Fetal Heart Rate Tracings

  Each fetal heart rate tracing was evaluated in 15 min increments from the completion of epidural placement and initial dose administration. ACOG Category I, II, and III was assigned to each 15 min increment.

  First 60 minutes following epidural placement

Secondary Outcomes (3)

• New Onset Hypotension (>20% Decrease in Systolic and/or Diastolic Blood Pressure)

  First 60 minutes following epidural placement

• Interventions to Correct Maternal Hypotension or Fetal Heart Rate Abnormalities (Position Change, Supplemental Oxygen, Vasopressor Support, Emergent Operative Delivery)

  First 60 minutes following epidural placement

• Adverse Events (Pulmonary Edema)

  Duration of intrapartum course

Study Arms (2)

Standard IV Preload

NO INTERVENTION

Patients in this arm will receive 500mL of Lactated Ringer's solution, which is the standard IV fluid preload used on Labor and Delivery at MetroHealth Medical Center

Volume Replacement IV Preload

EXPERIMENTAL

Patients in this arm will receive 1500mL of Lactated Ringer's solution

Drug: Lactated Ringer's

Interventions

Lactated Ringer's DRUG

1500 cc of IV Fluid (crystalloid) used for preload prior to epidural administration in the treatment arm. Control arm receives 500 cc.

Also known as: Ringer's Lactate

Volume Replacement IV Preload

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy with gestational age ≥ 35 weeks
• Admission for delivery
• Age 18 or older
• Desires neuraxial analgesia in labor

You may not qualify if:

• Maternal pulse pressure \< 45 mmHg on admission (verified by repeat blood pressure)
• Category 1 FHT on admission/prior to epidural placement
• Epidural placement within 6 hours of admission to Labor and Delivery
• Multiple gestation
• Intrauterine growth restriction
• Hypertensive disorders (gestational hypertension, chronic hypertension, and preeclampsia/eclampsia)
• Gestational or pregestational diabetes mellitus
• Substance abuse
• Intrauterine fetal demise
• Congenital or chromosomal fetal abnormalities
• Category II or III FHR tracing on admission to L\&D (pre-epidural)
• Contraindication to neuraxial aesthesia (e.g. thrombocytopenia)
• Maternal cardiomyopathy, congenital heart disease, active pulmonary edema or any other underlying maternal cardiopulmonary condition that increases the risk of pulmonary edema
• Maternal renal insufficiency (serum creatinine \> 1.0)
• Maternal hypotension (as defined in secondary outcomes below) prior to epidural placement

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (23)

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  PMID: 22161362 BACKGROUND

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  PMID: 15321453 BACKGROUND

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• Vricella LK, Louis JM, Mercer BM, Bolden N. Impact of morbid obesity on epidural anesthesia complications in labor. Am J Obstet Gynecol. 2011 Oct;205(4):370.e1-6. doi: 10.1016/j.ajog.2011.06.085. Epub 2011 Jun 29.

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  PMID: 19546798 BACKGROUND

• Lappen JR, Myers SA, Bolen N, Mercer BM, Chien EKS. Maternal Pulse Pressure and the Risk of Postepidural Complications: A Randomized Controlled Trial. Obstet Gynecol. 2017 Dec;130(6):1366-1376. doi: 10.1097/AOG.0000000000002326.

  PMID: 29112650 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Justin R. Lappen MD
• Organization: University Hospitals Cleveland Medical Center

Justin.Lappen@UHhospitals.org

216-844-3787

Study Officials

• Justin R Lappen, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Reproductive Biology

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 1, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 9, 2018
• Results First Posted: June 8, 2018

Record last verified: 2018-06

Locations

US (1)