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PregnancyNCT02121184

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

A study testing Routine oxytocin and Half-dose oxytocin in people with Pregnancy and Labor Pain, run by Northwestern University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Labor Pain
What is being tested?
Routine oxytocin and Half-dose oxytocin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteUnited States
Study dates
Apr 2014to 21 Sep 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Prentice Women's Hospital

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Clinical Trial Evaluating the Interaction of Rapid Hydration and the Rate of Oxytocin Labor Augmentation on Fetal Heart Rate Changes and Maternal Fetal Outcomes

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.

Read the detailed description

Informed, written consent will be obtained. At the time of request for labor analgesia, group assignment will be determined by opening an opaque envelope. Patients will be randomized to one of four groups.

All subjects will receive a maintenance infusion of 125 mL Lactated Ringers (LR) solution throughout the study. For patients in Groups A or B, an intravenous bolus of 1000 mL LR will be initiated when the patient is positioned for epidural placement. The bolus will be administered through a free-flowing wide open intravenous catheter until complete.

Patients in Groups C and D will not receive any additional fluid bolus and will only receive the maintenance infusion of 125 mL LR during the study period. Blinding will be maintained by the Labor and Delivery nurse by covering up the LR bolus fluid bag.

If the patient is randomized to groups B or D, the dose of oxytocin currently being administered will be halved and not increased for the duration of the study period (60 minutes after the initiation of CSE).

Being tested
Routine oxytocin, Half-dose oxytocin
Keywords
Oxytocin, Labor, Obstetric, Non-reassuring fetal heart rate, Epidural
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine oxytocinDrug

    Also called Pitocin

    per regular oxytocin protocols

  • Half-dose oxytocinDrug

    Also called Pitocin

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

Study groups in NCT02121184
Study groupRoleWhat they receive
Routine OxytocinActive comparatorLactated 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
Receives: Drug: Routine oxytocin
Half-dose OxytocinExperimentalLactated 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.
Receives: Drug: Half-dose oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completion21 Sep 2021
  4. Study completion21 Sep 2021

Why it stopped: The study was terminated due to low enrollment due to competing studies and the PI has now left Northwestern.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02121184
Sponsor's protocol ID
STU00074673
Status last verified
May 2024
First submitted
16 Apr 2014
Last updated
29 May 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11950182

  • 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.

    PubMed 19104358

  • 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.

    PubMed 7943823

  • 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.

    PubMed 1732771

  • 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.

    PubMed 998176

  • 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.

    PubMed 1603479

  • 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.

    PubMed 8822656

  • 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.

    PubMed 10472877

  • 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.

    PubMed 10901564

  • 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.

    PubMed 10992845

  • 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.

    PubMed 8957980

  • 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.

    PubMed 19546798

Questions about this trial

What is this clinical trial studying?

A study testing Routine oxytocin and Half-dose oxytocin in people with Pregnancy and Labor Pain, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Non-reassuring Fetal Heart Rate Tracings. (time frame: Request for labor analgesia up to the first 60 minutes after the epidural placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02121184, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.

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