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Cervical Capsaicin for Labor Induction and Pain Relief

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ClinicalTrials.gov Identifier: NCT00771511
Recruitment Status : Withdrawn (PI left the institution.)
First Posted : October 13, 2008
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):

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. 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 or disease Intervention/treatment Phase
Labor Pain Pregnancy Loss Labor Induction Drug: capsaicin Drug: Placebo Phase 4

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).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cervical Capsaicin for Labor Induction and Pain Relief
Study Start Date : October 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Pain report during labor [ Time Frame: 48 hours after labor induction ]

Secondary Outcome Measures :
  1. Bishop's score [ Time Frame: 48 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
More Information

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00771511     History of Changes
Other Study ID Numbers: AAAD5899
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Capsaicin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents