Clinical trial NCT00787176: The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Official title: The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Labor Pain
Keywords: Oxytocin
Labor, Obstetric
Non-reassuring fetal heart rate
epidural
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2008-11-07
Enrollment: 251
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: After obtaining informed, written consent, candidates were randomized to one of four groups at the time of request for labor analgesia. All subjects received a maintenance infusion of Lactated Ringers(LR). For candidates in Groups A or B, an intravenous bolus of 1000 mL of LR was initiated. Candidates in Groups C and D did not receive any additional fluid. If randomized to group A or C, the oxytocin management was continued as per the normal active management of labor protocal (AMOL). If randomized to groups B or D, the dose of oxytocin that was being administered was halved and not increased until 60 minutes after the initiation of epidural analgesia. Fetal heart rate monitoring and frequency of uterine contractions were recorded by external tocodynamometry.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
timeFrame: Request for labor analgesia up to the first 30 minutes after the placement of epidural
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Paloma Toledo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.