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Neonatal NeurobehaviorNCT01497509

Intrapartum Epidural Fentanyl and Breastfeeding in the Immediate Postpartum Period: a Randomized, Controlled, Double-blinded Study

A study testing Bolus 10mL 0.25% bupivacaine/ep 1:600,000; infusion 10mL/hour 0.25% bupivacaine and epi 1:800,000, Bolus 10mL 0.25% bupivacaine/ epinephrine 1:600,000;infusion 10mL/hour 0.25% bupivacaine, 2 mcg/mL fentanyl, and epinephrine 1:800,000 and Bolus 10mL 0.25% bupivacaine, 10mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 2.5 mcg/mL fentanyl, and epi 1:800,000 in people with Neonatal Neurobehavior and Breastfeeding Outcomes, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Although intrapartum epidural analgesia is frequently implicated in adverse breast-feeding outcomes, many previous studies feature major design limitations that preclude widespread applicability of findings. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Bolus 10mL 0.25% bupivacaine/ep 1:600,000; infusion 10mL/hour 0.25% bupivacaine and epi 1:800,000, Bolus 10mL 0.25% bupivacaine/ epinephrine 1:600,000;infusion 10mL/hour 0.25% bupivacaine, 2 mcg/mL fentanyl, and epinephrine 1:800,000 and Bolus 10mL 0.25% bupivacaine, 10mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 2.5 mcg/mL fentanyl, and epi 1:800,000
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2012to Nov 2012
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Singleton pregnancy
  • Maternal age 18+
  • Intention to breast-feed at time of hospital admission

Who cannot join

  • Delivery by Cesarean section
  • Neonatal morbidity requiring admission to neonatal intensive care unit

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University Hospitals Case Medical Center

    Cleveland, Ohio

Other trials in United States

About this study

Official title: Effect of Intrapartum Epidural Fentanyl Upon Breastfeeding in the Immediate Postpartum Period: a Randomized, Controlled, Double-blinded Study

Although intrapartum epidural analgesia is frequently implicated in adverse breast-feeding outcomes, many previous studies feature major design limitations that preclude widespread applicability of findings. Some fail to control for the precise pharmacologic composition of the epidural infusion, including whether or not an opioid, such as fentanyl, is even used at all in addition to local anesthetic or whether a combined spinal/epidural or purely epidural technique is used. The drugs used in epidural infusions not only have different mechanisms of action and lipophilicities but are also transferred across the placenta in varying proportions, with one study identifying an umbilical vein/maternal vein ratio of 0.94 for epidural fentanyl and 0.30 for bupivacaine, and another finding significantly different umbilical cord fentanyl concentrations among neonates whose mothers' epidural infusions contained >150 micrograms fentanyl, <150 micrograms, or none at all. It is also possible that the same total dose of epidural fentanyl could affect neonates differently depending upon the time course over which it was administered - namely, whether fentanyl is included in both the initial epidural bolus and the subsequent infusion or solely in the infusion. In two studies, mean umbilical vein concentrations of fentanyl did not correlate with total epidural infusion time, but both of these featured sample sizes fewer than 30, necessitating further research. Another limitation of some previous studies is defining success solely as the time to cessation of breast-feeding. Questionnaires mailed to mothers months or even years postpartum may generate unreliable data. If epidural medications truly mediate some physiologic effect upon breast-feeding, then the optimal study period is immediately post-delivery, specifically before the drugs are cleared from the maternal and neonatal circulations. After hospital discharge, many new factors - such as a mother's need to return to work or lack of social support - begin to confound the picture of breast-feeding success. Full-time employment outside the home has been significantly associated with decreased likelihood of breast-feeding at 6 months postpartum. Some studies also fail to control for intent to breast-feed at the time of hospital admission, number of infants previously breast-fed, or labor duration. Failure to account for oxytocin augmentation of labor is also problematic, as intravenous intrapartum oxytocin infusion has been shown to decrease a woman's endogenous serum oxytocin concentration on the second day postpartum in a dose-dependent fashion, which can subsequently impair milk release and, thus, decrease breast-feeding success.

Epidural analgesia may worsen breast-feeding outcomes by attenuating neonatal exhibition of neurobehaviors tied to feeding, such as sucking, rooting, and swallowing, during the immediate postpartum period. This critical period is when mother and baby make their first attempts at breast-feeding and set a precedent for subsequent interactions. Neonatal feeding behavior in the early postpartum period is an important predictor of long-term breast-feeding success; those babies who feed most vigorously during their first days of life are significantly more likely to still be breast-feeding at 3 or 6 months than those who exhibit any lesser degree of breast-feeding enthusiasm. Radzyminski et al. found no significant dose-response relationship for either epidural bupivacaine or fentanyl regarding neonatal feeding behaviors, and Porter et al. found no significant effect of epidural fentanyl, mean dose 184 micrograms, upon neonatal APGAR scores, incidence of respiratory depression, or NACS scores (Neurologic and Adaptive Capacity Scores) at 2 or 24 hours post-delivery. Beilin et al. found that neonatal NACS scores were significantly lower when mothers' epidural infusions contained greater than 150 micrograms total epidural fentanyl than when they contained only bupivacaine.

In this randomized, controlled, double-blinded study, we investigate whether intrapartum epidural fentanyl significantly decreases the likelihood of breast-feeding at hospital discharge and increases the incidence of neonatal deficits in latching on to the breast and audibly swallowing during the first three hours of life. We hypothesize that these effects will be dose-dependent but will have no relation to the time course over which the epidural fentanyl is administered. We also investigate whether oxytocin augmentation of labor and decreased amount of skin-to-skin contact during the first hour of life are associated with significantly decreased breast-feeding rates at hospital discharge.

Read the detailed description

NACS scores do not specifically measure feeding behaviors, but rather the five general areas of adaptive capacity, passive tone, active tone, primary reflexes, and alertness/crying/motor activity. Conversely, the Preterm Infant Breastfeeding Behavior Scale (PIBBS)specifically examines neonatal rooting, latching, sucking, and swallowing behaviors as well as general activity level, thus producing a comprehensive picture of breast-feeding interactions.

Beilin et al. previously performed a randomized, controlled, double-blinded study of multiparous women who were randomized to receive intrapartum epidural analgesia that contained, in addition to bupivacaine, either greater than 150 micrograms total fentanyl, less than 150 micrograms, or zero. This study had several limitations. Breast-feeding difficulties were not assessed until 24 hours postpartum, long after the neonate would have been expected to have fully metabolized the drugs. Like most previous studies, Beilin et al. also did not control for skin-to-skin mother-infant contact. According to a prospective cohort study of 21,842 mothers in 19 hospitals, the likelihood of exclusive breast-feeding throughout the hospital stay is positively, significantly correlated with the number of minutes of skin-to-skin contact during the first three hours postpartum, even after controlling for intention to breast-feed at the time of hospital admission. Another randomized, controlled, double-blinded study found no significant differences regarding breast-feeding initiation or breast-feeding rates at 12 months postpartum among women who received bupivacaine-only epidural analgesia, combined spinal-epidural analgesia with mean fentanyl dose 107.3 micrograms, or epidural infusion with mean fentanyl dose 162.8 micrograms. All fentanyl was administered only as part of a continuous infusion and never in an initial bolus, so the potentially different effects resulting from large loading doses of fentanyl compared to gradual infusion could not be studied. The authors did not objectively measure neonatal feeding behavior, relying solely upon maternal interviewing at 24-48 hours post-delivery, and they studied only nulliparous women.

In a pilot study of 310 mothers who delivered at University Hospitals Case Medical Center (Cleveland, Ohio) between September 2009 and February 2010, we found that duration of epidural infusion was significantly correlated with decreased neonatal ability to successfully latch onto the breast and audibly swallow during the first three hours of life. All infusions contained identical doses of fentanyl and bupivacaine.

Being tested
Bolus 10mL 0.25% bupivacaine/ep 1:600,000; infusion 10mL/hour 0.25% bupivacaine and epi 1:800,000, Bolus 10mL 0.25% bupivacaine/ epinephrine 1:600,000;infusion 10mL/hour 0.25% bupivacaine, 2 mcg/mL fentanyl, and epinephrine 1:800,000, Bolus 10mL 0.25% bupivacaine, 10mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 2.5 mcg/mL fentanyl, and epi 1:800,000, Bolus 10mL 0.25% bupivacaine, 5 mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 3.5 mcg/mL fentanyl, and epi 1:800,000

What participants receive

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

  • Bolus 10mL 0.25% bupivacaine/ep 1:600,000; infusion 10mL/hour 0.25% bupivacaine and epi 1:800,000Drug

  • Bolus 10mL 0.25% bupivacaine/ epinephrine 1:600,000;infusion 10mL/hour 0.25% bupivacaine, 2 mcg/mL fentanyl, and epinephrine 1:800,000Drug

  • Bolus 10mL 0.25% bupivacaine, 10mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 2.5 mcg/mL fentanyl, and epi 1:800,000Drug

  • Bolus 10mL 0.25% bupivacaine, 5 mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 3.5 mcg/mL fentanyl, and epi 1:800,000Drug

Study groups in NCT01497509
Study groupRoleWhat they receive
Patients electing to receive intrapartum epidural analgesiaExperimentalNot described
Receives: Drug: Bolus 10mL 0.25% bupivacaine/ep 1:600,000; infusion 10mL/hour 0.25% bupivacaine and epi 1:800,000; Drug: Bolus 10mL 0.25% bupivacaine/ epinephrine 1:600,000;infusion 10mL/hour 0.25% bupivacaine, 2 mcg/mL fentanyl, and epinephrine 1:800,000; Drug: Bolus 10mL 0.25% bupivacaine, 10mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 2.5 mcg/mL fentanyl, and epi 1:800,000; Drug: Bolus 10mL 0.25% bupivacaine, 5 mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 3.5 mcg/mL fentanyl, and epi 1:800,000
Patients electing not to receive epidural analgesiaNo interventionNot described

What is being measured

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

  1. Neonatal rooting, latching, sucking, and swallowing behaviors

    Neonatal feeding behaviors will be scored using the Preterm Infant Breastfeeding Behavior Scale (PIBBS), which has good interrater reliability with full-term neonates as well as pre-term.

    Measured: First 4 hours post-delivery

Secondary outcomes (1)
  1. Breastfeeding outcome

    Measured: Time of hospital discharge (on average, 48 hours post-delivery)

Timeline

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

  1. First posted22 Dec 2011 (estimated)
  2. Study startMay 2012
  3. Primary completionNov 2012 (estimated)
  4. Study completionNov 2012 (estimated)

Why it stopped: Study never started

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01497509
Sponsor's protocol ID
RCT epidural fentanyl
Status last verified
Apr 2012
First submitted
16 Dec 2011
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Bolus 10mL 0.25% bupivacaine/ep 1:600,000; infusion 10mL/hour 0.25% bupivacaine and epi 1:800,000, Bolus 10mL 0.25% bupivacaine/ epinephrine 1:600,000;infusion 10mL/hour 0.25% bupivacaine, 2 mcg/mL fentanyl, and epinephrine 1:800,000 and Bolus 10mL 0.25% bupivacaine, 10mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 2.5 mcg/mL fentanyl, and epi 1:800,000 in people with Neonatal Neurobehavior and Breastfeeding Outcomes, run by University Hospitals Cleveland Medical Center 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 18 Apr 2022. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Neonatal rooting, latching, sucking, and swallowing behaviors (time frame: First 4 hours post-delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Apr 2022.

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