Cervical Capsaicin for Labor Induction and Pain Relief

This study has been withdrawn prior to enrollment.
(PI left the institution.)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00771511
First received: October 10, 2008
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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. We hypothesize that application of capsaicin to the uterine cervix will enhance cervical ripening and desensitize pain fibers such that delivery is less painful.


Condition Intervention Phase
Labor Pain
Pregnancy Loss
Labor Induction
Drug: capsaicin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cervical Capsaicin for Labor Induction and Pain Relief

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Pain report during labor [ Time Frame: 48 hours after labor induction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bishop's score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Capsaicin cream applied to cervix after lidocaine gel
Drug: capsaicin
capsaicin cream 0.1% 10 ml applied to cervix
Placebo Comparator: 2
only lidocaine applied to the cervix
Drug: Placebo
Only lidocaine gel will be appled to the cervix

Detailed Description:

Induction of labor is associated with increased risk of cesarean section and elevated pain when compared to labor of spontaneous onset (1,2). 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.

We 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(3).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 (unpublished data).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IUFD after 20 weeks gestation

Exclusion Criteria:

  • Chorioamnionitis
  • Chronic pain syndrome
  • Current pain meds during pregnancy
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00771511     History of Changes
Other Study ID Numbers: AAAD5899
Study First Received: October 10, 2008
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Labor Pain
Fetal Death
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pregnancy Complications
Death
Pathologic Processes
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014