Trial · Interventional

TerminatedNot applicableResults postedRegistry data

The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes

NCTNCT00787176Other id0524-034

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Study concluded prematurely prior to meeting intended goal recruitment.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Not applicable
Enrollment: 251 participants (actual)
Sponsor: Northwestern University · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Sept 2007
Primary completion: Jul 2012
Completion: Jul 2012
First posted: 7 Nov 2008 (estimated)
Last update posted: 13 Jan 2022
Conditions: Pregnancy · Labor Pain

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2007200820092010201120122013

N/A
The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
NCT00787176
Sept 2007 to Jul 2012
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Group A Intravenous bolus of 1000 ml lactated ringers solutionDrug
Group B Intravenous bolus bolus 1000 ml lactated ringers solution oxytocin decrease to 1/2 current rateDrug
Group C 125 mL/hr of lactated ringersDrug
Group D 125 mL/hr lactated ringers oxytocin decreased to 1/2 current rateDrug

Arms4

Active comparator
Group A
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Experimental
Group B
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.
Active comparator
Group C
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Experimental
Group D
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
Time frame · Request for labor analgesia up to the first 30 minutes after the placement of epidural
Registry description
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

Group	Value (participants)
Group A	47
Group B	54
Group C	44
Group D	47

Secondary and other outcome results(1)

Post hoc outcomeNumber· Delivery

Delivery Type

Group	Value (participants)
Group A	50
Group B	43
Group C	44
Group D	44
Group Sum	181

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Group AAn intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol. Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.	0 / 69	0 / 69	0 / 69
Group BAn 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. Group B: 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.	0 / 62	0 / 62	0 / 62
Group CThe maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol. Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.	0 / 60	0 / 60	0 / 60
Group DThe 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. Group D: 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.	0 / 60	0 / 60	0 / 60

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 1992

A controlled trial of a program for the active management of labor.

López-Zeno et al. 1992The New England journal of medicinecited by 150

PMID 1732771DOI 10.1056/nejm199202133260705PUB-01732771

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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