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Labor PainPhase 4NCT00771511

Cervical Capsaicin for Labor Induction and Pain Relief

A Phase 4 study testing capsaicin in people with Labor Pain and Pregnancy Loss, run by Columbia University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Labor Pain, Pregnancy Loss, Labor Induction
What is being tested?
capsaicin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2010to Jun 2011
Phase
Phase 4
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • IUFD after 20 weeks gestation

Who cannot join

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

About this study

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.

Read the 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.

Being tested
capsaicin, Placebo
Medical subject headings
Labor Pain

What participants receive

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

  • capsaicinDrug

    capsaicin cream 0.1% 10 ml applied to cervix

  • PlaceboDrug

    Only lidocaine gel will be appled to the cervix

Study groups in NCT00771511
Study groupRoleWhat they receive
1ExperimentalCapsaicin cream applied to cervix after lidocaine gel
Receives: Drug: capsaicin
2Placebo comparatoronly lidocaine applied to the cervix
Receives: Drug: Placebo

What is being measured

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

  1. Pain report during labor

    Measured: 48 hours after labor induction

Secondary outcomes (1)
  1. Bishop's score

    Measured: 48 hours

Timeline

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

  1. First posted13 Oct 2008 (estimated)
  2. Study startOct 2010 (estimated)
  3. Primary completionJun 2011 (estimated)
  4. Study completionJun 2011 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771511
Sponsor's protocol ID
AAAD5899
Status last verified
Aug 2021
First submitted
10 Oct 2008
Last updated
9 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing capsaicin in people with Labor Pain and Pregnancy Loss, run by Columbia University.

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 1 inclusion and 3 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 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Pain report during labor (time frame: 48 hours after labor induction). 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 9 Aug 2021.

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