Trial Outcomes & Findings for Pulse Pressure and Post-epidural Fetal Heart Rate Changes (NCT NCT02565485)
NCT ID: NCT02565485
Last Updated: 2018-07-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
276 participants
Primary outcome timeframe
First 60 minutes following epidural placement
Results posted on
2018-07-09
Participant Flow
Participant milestones
| Measure |
Standard IV Preload
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
Patients in this arm will receive 1500mL of Lactated Ringer's solution
Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
137
|
|
Overall Study
COMPLETED
|
139
|
137
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pulse Pressure and Post-epidural Fetal Heart Rate Changes
Baseline characteristics by cohort
| Measure |
Standard IV Preload
n=139 Participants
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
n=137 Participants
Patients in this arm will receive 1500mL of Lactated Ringer's solution
Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
139 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.0 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
26.4 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
139 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
139 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 60 minutes following epidural placementEach 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.
Outcome measures
| Measure |
Standard IV Preload
n=139 Participants
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
n=137 Participants
Patients in this arm will receive 1500mL of Lactated Ringer's solution
Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration
|
|---|---|---|
|
Incidence of New-onset Category II or III Fetal Heart Rate Tracings
|
72 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: First 60 minutes following epidural placementOutcome measures
| Measure |
Standard IV Preload
n=139 Participants
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
n=137 Participants
Patients in this arm will receive 1500mL of Lactated Ringer's solution
Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration
|
|---|---|---|
|
New Onset Hypotension (>20% Decrease in Systolic and/or Diastolic Blood Pressure)
|
48 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: First 60 minutes following epidural placementOutcome measures
| Measure |
Standard IV Preload
n=139 Participants
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
n=137 Participants
Patients in this arm will receive 1500mL of Lactated Ringer's solution
Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration
|
|---|---|---|
|
Interventions to Correct Maternal Hypotension or Fetal Heart Rate Abnormalities (Position Change, Supplemental Oxygen, Vasopressor Support, Emergent Operative Delivery)
|
61 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Duration of intrapartum coursePulmonary edema occurring after preload bolus through delivery was considered an adverse event.
Outcome measures
| Measure |
Standard IV Preload
n=139 Participants
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
n=137 Participants
Patients in this arm will receive 1500mL of Lactated Ringer's solution
Lactated Ringer's: IV Fluid (crystalloid) used for preload prior to epidural adminstration
|
|---|---|---|
|
Adverse Events (Pulmonary Edema)
|
0 Participants
|
0 Participants
|
Adverse Events
Standard IV Preload
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Volume Replacement IV Preload
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Justin R. Lappen MD
University Hospitals Cleveland Medical Center
Phone: 216-844-3787
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place