NCT00771511

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

October 10, 2008

Last Update Submit

August 3, 2021

Conditions

Labor PainPregnancy LossLabor Induction

Outcome Measures

Primary Outcomes (1)

  • Pain report during labor

    48 hours after labor induction

Secondary Outcomes (1)

  • Bishop's score

    48 hours

Study Arms (2)

1

EXPERIMENTAL

Capsaicin cream applied to cervix after lidocaine gel

Drug: capsaicin

2

PLACEBO COMPARATOR

only lidocaine applied to the cervix

Drug: Placebo

Interventions

capsaicinDRUG

capsaicin cream 0.1% 10 ml applied to cervix

1
PlaceboDRUG

Only lidocaine gel will be appled to the cervix

2

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • IUFD after 20 weeks gestation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Labor Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • Pamela Flood, MD

    Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 13, 2008

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 9, 2021

Record last verified: 2021-08