The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes - Full Text View

Sponsored by:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00787176

Purpose

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: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin administration will have fewer non-reassuring FHR changes.

Condition	Intervention
Pregnancy Labor	Drug: lactated ringers solution and normal oxytocin dose Drug: 1000 mL bolus Half-dose oxytocin Drug: No bolus of lactated ringers solution and routine oxytocin Drug: No bolus of lactated ringers solution and a half-dose oxytocin

Drug Information available for: Oxytocin Ringer's lactate Ringer's solution

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Association Between Fluid Administration,Oxytocin Administration, and Fetal Heart Rate Changes

Further study details as provided by Northwestern University:

Primary Outcome Measures:

The primary endpoint is the incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of CSE. [ Time Frame: Prospective: look forward using periodic observations collected predominantly following subject enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	352
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
1: Experimental A 1000 mL bolus Routine oxytocin	Drug: lactated ringers solution and normal oxytocin dose lactated ringers solution and normal oxytocin dose
2: Experimental 1000 mL bolus Half-dose oxytocin	Drug: 1000 mL bolus Half-dose oxytocin 1000 mL bolus Half-dose oxytocin
3: Experimental No bolus of lactated ringers solution and routine oxytocin	Drug: No bolus of lactated ringers solution and routine oxytocin No bolus of lactated ringers Routine oxytocin
4: Experimental No bolus Half-dose oxytocin	Drug: No bolus of lactated ringers solution and a half-dose oxytocin No bolus of lactated ringers solution and a half-dose oxytocin

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-60
Healthy nulliparous or multiparous women
Term (>36 week gestation)
Singleton pregnancy
Spontaneous labor
Spontaneous rupture of membranes, and request neuraxial analgesia, and will be managed by the active management of labor protocol (AMOL) and receive oxytocin, or receive oxytocin augmentation per PWH's protocols

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
Prior; non-vertex presentation;
Scheduled induction of labor
Any contraindication to neuraxial analgesia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787176

Contacts

Contact: Cynthia A Wong, M.D.	321-472-3590	c-wong2@Northwestern.edu
Contact: Robert McCarthy, PharmD

Locations

United States, Illinois
Prentice WOmen's Hospital	Recruiting
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

More Information

Publications:

Mardirosoff C, Dumont L, Boulvain M, Tramèr MR. Fetal bradycardia due to intrathecal opioids for labour analgesia: a systematic review. BJOG. 2002 Mar;109(3):274-81. Review.

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. No abstract available.

López-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.

Responsible Party:	NOrthwestern University ( Cynthia A. WOng, M.D. )
Study ID Numbers:	0524-034
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00787176
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Oxytocin
Term
Singleton
Labor, Obstetric

Study placed in the following topic categories:

Oxytocin

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Physiological Effects of Drugs
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009