Nonviable PregnancyPhase 3NCT01708330
The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies
A Phase 3 study testing Lidocaine in people with Nonviable Pregnancy, run by Bridgeport Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nonviable Pregnancy
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2016
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital Triage
Providence, Rhode Island, 02905
About this study
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.
- Conditions
- Nonviable Pregnancy
- Being tested
- Lidocaine, Placebo gel
- Keywords
- manual vacuum aspiration, missed abortion, incomplete abortion, nonviable pregnancy, topical lidocaine
- Medical subject headings
- Abortion, Missed, Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
2% Lidocaine gel
Placebo gelDrug
Also called KY Jelly
odorless, colorless gel will be used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo gel | Placebo comparator | Placebo gel applied topically to the cervix Receives: Drug: Placebo gel |
| Lidocaine gel | Experimental | 2% lidocaine gel applied topically to the cervix Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during intracervical block
Pain on visual analogue scale
Measured: immediate
Secondary outcomes (3)
Pain during tenaculum placement
Pain on visual analogue scale
Measured: immediate
Pain during cervical dilation
Pain on visual analogue scale
Measured: immediate
Pain during uterine aspiration
Pain on visual analogue scale
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonviable PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridgeport Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Responsible party
- Principal investigator, Amanda Tower, Bridgeport Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708330
- Sponsor's protocol ID
- 12-0039
- Status last verified
- Jul 2016
- First submitted
- 11 Oct 2012
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies
- ClinicalTrials.gov ID
- NCT01708330
- Acronym / sponsor ID
- 12-0039
- Conditions
- Nonviable Pregnancy
- Keywords
- manual vacuum aspiration, missed abortion, incomplete abortion, nonviable pregnancy, topical lidocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bridgeport HospitalUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Study start
- Oct 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo gel | Placebo comparator | Drug: Placebo gelPlacebo gel applied topically to the cervix |
| Lidocaine gel | Experimental | Drug: Lidocaine2% lidocaine gel applied topically to the cervix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine2% Lidocaine gel | Drug | Lidocaine gel |
| Placebo gelAlso: KY Jellyodorless, colorless gel will be used as a placebo | Drug | Placebo gel |
Primary outcome
Pain during intracervical block
Time frame: immediate
Pain on visual analogue scale
3 secondary outcomes
Pain during tenaculum placement
Time frame: immediate
Pain during cervical dilation
Time frame: immediate
Pain during uterine aspiration
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine in people with Nonviable Pregnancy, run by Bridgeport Hospital at 1 site in United States.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 during intracervical block (time frame: immediate). 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 20 Jul 2016.