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

NCT02121184 | Terminated Results

• 1 other identifier: STU00074673
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy; Labor Pain

Keywords

Oxytocin; Labor, Obstetric; Non-reassuring fetal heart rate; Epidural

Outcome Measures

Primary Outcomes (1)

• Incidence of Non-reassuring Fetal Heart Rate Tracings.

  Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia

  Request for labor analgesia up to the first 60 minutes after the epidural placement

Study Arms (2)

Routine Oxytocin

ACTIVE COMPARATOR

Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. Oxytocin management will continue as per the routine oxytocin protocol

Drug: Routine oxytocin

Half-dose Oxytocin

EXPERIMENTAL

Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. A half-dose oxytocin will be initiated and not increased until 60 minutes after.

Drug: Half-dose oxytocin

Interventions

Routine oxytocin DRUG

per regular oxytocin protocols

Also known as: Pitocin

Routine Oxytocin

Half-dose oxytocin DRUG

The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia

Also known as: Pitocin

Half-dose Oxytocin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Under 18 years old
• Presence of any systemic disease (ex: diabetes mellitus, hypertension, preeclampsia
• Use of chronic analgesic medications
• Prior administration of system opioid labor analgesia
• Non-vertex presentation
• Induction of Labor
• Contraindication to neuraxial analgesia

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (12)

• 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: 11950182 BACKGROUND

• Abrao KC, Francisco RPV, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):41-47. doi: 10.1097/AOG.0b013e31818f5eb6.

  PMID: 19104358 BACKGROUND

• 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: 7943823 BACKGROUND

• 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: 1732771 BACKGROUND

• Lindmark G, Nilsson BA. A comparative study of uterine activity in labour induced with prostaglandin F2alpha or oxytocin and in spontaneous labour. I. Pattern of the uterine contractions. Acta Obstet Gynecol Scand. 1976;55(5):453-60. doi: 10.3109/00016347609158529.

  PMID: 998176 BACKGROUND

• Satin AJ, Leveno KJ, Sherman ML, Brewster DS, Cunningham FG. High- versus low-dose oxytocin for labor stimulation. Obstet Gynecol. 1992 Jul;80(1):111-6.

  PMID: 1603479 BACKGROUND

• Hourvitz A, Alcalay M, Korach J, Lusky A, Barkai G, Seidman DS. A prospective study of high- versus low-dose oxytocin for induction of labor. Acta Obstet Gynecol Scand. 1996 Aug;75(7):636-41. doi: 10.3109/00016349609054688.

  PMID: 8822656 BACKGROUND

• Merrill DC, Zlatnik FJ. Randomized, double-masked comparison of oxytocin dosage in induction and augmentation of labor. Obstet Gynecol. 1999 Sep;94(3):455-63. doi: 10.1016/s0029-7844(99)00338-5.

  PMID: 10472877 BACKGROUND

• Sadler LC, Davison T, McCowan LM. A randomised controlled trial and meta-analysis of active management of labour. BJOG. 2000 Jul;107(7):909-15. doi: 10.1111/j.1471-0528.2000.tb11091.x.

  PMID: 10901564 BACKGROUND

• Kinsella SM, Pirlet M, Mills MS, Tuckey JP, Thomas TA. Randomized study of intravenous fluid preload before epidural analgesia during labour. Br J Anaesth. 2000 Aug;85(2):311-3. doi: 10.1093/bja/85.2.311.

  PMID: 10992845 BACKGROUND

• Cheek TG, Samuels P, Miller F, Tobin M, Gutsche BB. Normal saline i.v. fluid load decreases uterine activity in active labour. Br J Anaesth. 1996 Nov;77(5):632-5. doi: 10.1093/bja/77.5.632.

  PMID: 8957980 BACKGROUND

• ACOG Practice Bulletin No. 106: Intrapartum fetal heart rate monitoring: nomenclature, interpretation, and general management principles. Obstet Gynecol. 2009 Jul;114(1):192-202. doi: 10.1097/AOG.0b013e3181aef106. No abstract available.

  PMID: 19546798 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Ended trial early due to low enrollment. Could not obtain a certified assessments of fetal heart tracings.

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312 695 1064

Study Officials

• Charles Hogue, M.D.

  Northwestern University

  STUDY CHAIR

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 23, 2014
• Study Start: April 1, 2014
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)