Trial · Interventional

TerminatedNot applicableResults postedRegistry data

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

NCTNCT02121184Other idSTU00074673

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: The study was terminated due to low enrollment due to competing studies and the PI has now left Northwestern.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Not applicable
Enrollment: 172 participants (actual)
Sponsor: Northwestern University · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Apr 2014
Primary completion: 21 Sept 2021
Completion: 21 Sept 2021
First posted: 23 Apr 2014 (estimated)
Last update posted: 29 May 2024
Conditions: Pregnancy · Labor Pain

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142016201820202022

N/A
Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
NCT02121184
Apr 2014 to 21 Sept 2021
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Routine oxytocinDrug
Half-dose oxytocinDrug

Arms2

Active comparator
Routine Oxytocin
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
Experimental
Half-dose Oxytocin
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Incidence of Non-reassuring Fetal Heart Rate Tracings.
Time frame · Request for labor analgesia up to the first 60 minutes after the epidural placement
Registry description
Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Incidence of Non-reassuring Fetal Heart Rate Tracings.

Group	Value
Routine Oxytocin	not posted
Half-dose Oxytocin	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Group ALactated 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 Routine oxytocin: per regular oxytocin protocols	0 / 86	0 / 86	0 / 86
Group BLactated 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. Half-dose oxytocin: The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia	0 / 86	0 / 86	0 / 86

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

More studies

7 studies on this page

Indexing hint: Randomized controlled trial · 2009

Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial.

Abrão et al. 2009Obstetrics and gynecologycited by 68

PMID 19104358DOI 10.1097/aog.0b013e31818f5eb6PUB-19104358

Full text at the publisher

Publisher page

Indexing hint: Meta-analysis (pooled) · 2000

A randomised controlled trial and meta-analysis of active management of labour.

Sadler et al. 2000BJOG : an international journal of obstetrics and gynaecologycited by 65

PMID 10901564DOI 10.1111/j.1471-0528.2000.tb11091.xPUB-10901564

Rights unknown

Source link

Indexing hint: Randomized controlled trial · 1999

Randomized, double-masked comparison of oxytocin dosage in induction and augmentation of labor.

Merrill et al. 1999Obstetrics and gynecologycited by 59

PMID 10472877DOI 10.1016/s0029-7844(99)00338-5PUB-10472877

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 1996

A prospective study of high- versus low-dose oxytocin for induction of labor.

Hourvitz et al. 1996Acta obstetricia et gynecologica Scandinavicacited by 15

PMID 8822656DOI 10.3109/00016349609054688PUB-08822656

Full text at the publisher

Publisher page

Indexing hint: Clinical trial · 1992

High- versus low-dose oxytocin for labor stimulation.

Satin et al. 1992Obstetrics and gynecologycited by 56

PMID 1603479PUB-01603479

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 1992

A controlled trial of a program for the active management of labor.

López-Zeno et al. 1992The New England journal of medicinecited by 150

PMID 1732771DOI 10.1056/nejm199202133260705PUB-01732771

Full text at the publisher

Publisher page

Indexing hint: Observational study · 1976

A comparative study of uterine activity in labour induced with prostaglandin F2alpha or oxytocin and in spontaneous labour. I. Pattern of the uterine contractions.

Lindmark et al. 1976Acta obstetricia et gynecologica Scandinavicacited by 7

PMID 998176DOI 10.3109/00016347609158529PUB-00998176

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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