Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00771511 |
| Other study ID # |
AAAD5899 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
October 2010 |
| Est. completion date |
June 2011 |
Study information
| Verified date |
August 2021 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
