The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Information source: Northwestern University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy; Labor
Intervention: 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)
Phase: N/A
Status: Recruiting
Sponsored by: Northwestern University Official(s) and/or principal investigator(s):
Cynthia A Wong, M.D., Principal Investigator, Affiliation: Northwestern University
Overall contact:
Cynthia A Wong, M.D., Phone: 321-472-3590, Email: c-wong2@Northwestern.edu
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: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin
administration will have fewer non-reassuring FHR changes.
Clinical Details
Official title: The Association Between Fluid Administration,Oxytocin Administration, and Fetal Heart Rate Changes
Study design: Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: The primary endpoint is the incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of CSE.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Female.
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.
Locations and Contacts
Cynthia A Wong, M.D., Phone: 321-472-3590, Email: c-wong2@Northwestern.edu
Prentice WOmen's Hospital, Chicago, Illinois 60611, United States; Recruiting
Additional Information
Related 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.
Starting date: September 2007
Last updated: August 6, 2010
|
