NCT00787176

Brief Summary

Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables which could affect fetal heart rate patterns at the time of initiation of analgesia, such as fluid administration and oxytocin management, could help us provide better care for our patients and their fetuses. Hypotheses: The combination of fluid administration and lower doses of oxytocin administration will have fewer adverse fetal heart rate changes in the first 60 minutes following initiation of labor analgesia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

January 13, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

4.8 years

First QC Date

November 6, 2008

Results QC Date

September 25, 2017

Last Update Submit

January 5, 2022

Conditions

PregnancyLabor Pain

Keywords

OxytocinLabor, ObstetricNon-reassuring fetal heart rateepidural

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia

    The number of participants who experience non-reassuring fetal heart rate tracings obtained via electronic recording during the first 30 minutes after the placement of epidural analgesia

    Request for labor analgesia up to the first 30 minutes after the placement of epidural

Study Arms (4)

Group A

ACTIVE COMPARATOR

An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.

Drug: Group A Intravenous bolus of 1000 ml lactated ringers solution

Group B

EXPERIMENTAL

An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.

Drug: Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rate

Group C

ACTIVE COMPARATOR

The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.

Drug: Group C 125 mL/hr of lactated ringers

Group D

EXPERIMENTAL

The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.

Drug: Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rate

Interventions

Group A Intravenous bolus of 1000 ml lactated ringers solutionDRUG

An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.

Also known as: A
Group A
Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rateDRUG

An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.

Also known as: B
Group B
Group C 125 mL/hr of lactated ringersDRUG

The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.

Also known as: C
Group C
Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rateDRUG

The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.

Also known as: D
Group D

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60
  • Healthy nulliparous or multiparous women
  • Term (\>36 week gestation)
  • Singleton pregnancy
  • Spontaneous labor or with spontaneous rupture of membranes
  • Receive oxytocin
  • Request neuraxial analgesia

You may not qualify if:

  • Under 18 years of age
  • Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
  • Use of chronic analgesic medications
  • Prior administration of systemic opioid labor analgesia
  • Non-vertex presentation
  • Induction of labor
  • Contraindication to neuraxial analgesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

  • Mardirosoff C, Dumont L, Boulvain M, Tramer MR. Fetal bradycardia due to intrathecal opioids for labour analgesia: a systematic review. BJOG. 2002 Mar;109(3):274-81. doi: 10.1111/j.1471-0528.2002.01380.x.

    PMID: 11950182BACKGROUND

  • Clarke VT, Smiley RM, Finster M. Uterine hyperactivity after intrathecal injection of fentanyl for analgesia during labor: a cause of fetal bradycardia? Anesthesiology. 1994 Oct;81(4):1083. doi: 10.1097/00000542-199410000-00041. No abstract available.

    PMID: 7943823BACKGROUND

  • Lopez-Zeno JA, Peaceman AM, Adashek JA, Socol ML. A controlled trial of a program for the active management of labor. N Engl J Med. 1992 Feb 13;326(7):450-4. doi: 10.1056/NEJM199202133260705.

    PMID: 1732771BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Ringer's LactateFumigant 93

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

Study recruitment was stopped before reaching the determined a priori sample size.

Results Point of Contact

Title
Paloma Toledo
Organization
Northwerstern University
p-toledo@northwestern.edu
312-472-3585

Study Officials

  • Paloma Toledo, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

September 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 13, 2022

Results First Posted

January 13, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)