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Withdrawn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
About this trial
This is an interventional treatment trial for Labor Pain
Eligibility Criteria
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
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Withdrawn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
Learn more about this trial
Cervical Capsaicin for Labor Induction and Pain Relief
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