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Cervical Capsaicin for Labor Induction and Pain Relief

Primary Purpose

Labor Pain, Pregnancy Loss, Labor Induction

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
capsaicin
Placebo
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • IUFD after 20 weeks gestation

Exclusion Criteria:

  • Chorioamnionitis
  • Chronic pain syndrome
  • Current pain meds during pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Capsaicin cream applied to cervix after lidocaine gel

    only lidocaine applied to the cervix

    Outcomes

    Primary Outcome Measures

    Pain report during labor

    Secondary Outcome Measures

    Bishop's score

    Full Information

    First Posted
    October 10, 2008
    Last Updated
    August 3, 2021
    Sponsor
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00771511
    Brief Title
    Cervical Capsaicin for Labor Induction and Pain Relief
    Official Title
    Cervical Capsaicin for Labor Induction and Pain Relief
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study never started
    Study Start Date
    October 2010 (Anticipated)
    Primary Completion Date
    June 2011 (Anticipated)
    Study Completion Date
    June 2011 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Columbia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In the setting of fetal demise it is important to help the mother deliver the fetus expeditiously and with as little physical trauma as possible. This study hypothesizes that application of capsaicin to the uterine cervix will enhance cervical ripening and desensitize pain fibers such that delivery is less painful.
    Detailed Description
    Induction of labor is associated with increased risk of cesarean section and elevated pain when compared to labor of spontaneous onset. In the setting of intrauterine fetal demise (IUFD), it is desirable to induce labor in order to achieve a successful vaginal delivery for the health and well being of the mother, thereby avoiding operative fetal extraction. The current protocol for midtrimester labor induction prior to 24 weeks gestational age includes intravaginal cytotec(misoprostol) 200 mcg every 6 hours for up to 24 hours, occasionally followed by oxytocin infusion. When an IUFD occurs at 24 or greater weeks gestational age, labor is induced with cytotec 25 or 50 mcg every 4 hours and/or oxytocin infusion. The investigators hypothesize that application of lidocaine to the uterine cervix followed by 0.1% capsaicin cream will facilitate cervical ripening and decrease the pain of labor induction when compared to use of a placebo cream. Capsaicin 8methylNvannilyl6nonenamide) activates TRPV1, a nonselective cation channel activated directly by heat, and low pH, and indirectly by a number of inflammatory factors, including nerve growth factor (NGF), bradykinin, lipids, and prostaglandins. Activation of TRPV1 by capsaicin results in an influx of Ca2 and Na ions, depolarization, exocytosis of neuropeptides and excitatory amino acids, and induces a burning sensation. This initial phase is followed by prolonged desensitiztion that is dose dependent. Once the TRPV1 receptor is desensitized, pain transmission through Ctype primary afferent receptors is reduced. The pain relief from capsaicin is due to desensitization of the TRPV1 receptor. The enhancement of cervical ripening is due to activation of primary afferent Cfibers, release of neuropeptides substance P, neurokinin A, calcitonin generelated peptide, secretoneurin and nitric oxide to help orchestrate a series of local inflammatory responses including vasodilation, vascular permeability with tissue edema and protein extravasation, and migration of inflammatory immune cells. In a study of pregnant rats, vaginal lidocaine gel was applied followed by capsaicin sham cream. A blinded observer monitored behavior via video over the next 72 hours. All animals treated with capsaicin delivered on day 22 with minimal pain behaviors while 90% of sham treated animals delivered as expected on day 23 with normal pain related behavior. All pups were delivered live and rearing and suckling behavior was normal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain, Pregnancy Loss, Labor Induction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Capsaicin cream applied to cervix after lidocaine gel
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    only lidocaine applied to the cervix
    Intervention Type
    Drug
    Intervention Name(s)
    capsaicin
    Intervention Description
    capsaicin cream 0.1% 10 ml applied to cervix
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Only lidocaine gel will be appled to the cervix
    Primary Outcome Measure Information:
    Title
    Pain report during labor
    Time Frame
    48 hours after labor induction
    Secondary Outcome Measure Information:
    Title
    Bishop's score
    Time Frame
    48 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: IUFD after 20 weeks gestation Exclusion Criteria: Chorioamnionitis Chronic pain syndrome Current pain meds during pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pamela Flood, MD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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