NCT01708330

Brief Summary

When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures. Women being treated at the Women \& Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure. The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

2.7 years

First QC Date

October 11, 2012

Last Update Submit

July 18, 2016

Conditions

Nonviable Pregnancy

Keywords

manual vacuum aspirationmissed abortionincomplete abortionnonviable pregnancytopical lidocaine

Outcome Measures

Primary Outcomes (1)

  • Pain during intracervical block

    Pain on visual analogue scale

    immediate

Secondary Outcomes (3)

  • Pain during tenaculum placement

    immediate

  • Pain during cervical dilation

    immediate

  • Pain during uterine aspiration

    immediate

Other Outcomes (1)

  • Complications

    1 hour after procedure

Study Arms (2)

Placebo gel

PLACEBO COMPARATOR

Placebo gel applied topically to the cervix

Drug: Placebo gel

Lidocaine gel

EXPERIMENTAL

2% lidocaine gel applied topically to the cervix

Drug: Lidocaine

Interventions

LidocaineDRUG

2% Lidocaine gel

Lidocaine gel
Placebo gelDRUG

odorless, colorless gel will be used as a placebo

Also known as: KY Jelly
Placebo gel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at the Women and Infants Triage/Women's Emergency Department
  • Vital signs are stable
  • Ages 18 and older
  • Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
  • Estimated gestational age up to 10 weeks
  • Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
  • Able to read English or Spanish
  • Able to give informed consent for involvement in the study

You may not qualify if:

  • Allergic to lidocaine, iodine or betadine
  • Known sensitivity to any component of the lidocaine or placebo gel.
  • In acute distress
  • Unable to give informed consent
  • Unable to read English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women and Infants Hospital Triage

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Abortion, MissedAbortion, Incomplete

Interventions

LidocaineK-Y jelly

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 16, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

US(1)