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| Name | Class |
|---|---|
| Women and Infants Hospital of Rhode Island | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo gel | Placebo Comparator | Placebo gel applied topically to the cervix |
|
| Lidocaine gel | Experimental | 2% lidocaine gel applied topically to the cervix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 2% Lidocaine gel |
| |
| Placebo gel |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during intracervical block | Pain on visual analogue scale | immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during tenaculum placement | Pain on visual analogue scale | immediate |
| Pain during cervical dilation | Pain on visual analogue scale |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | 1 hour after procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Infants Hospital Triage | Providence | Rhode Island | 02905 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 21, 2019 | |
| Reset | Feb 12, 2019 | |
| Release | Jan 13, 2020 | |
| Reset | Jan 22, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 21, 2019 | Feb 12, 2019 | |||
| Jan 13, 2020 |
| ID | Term |
|---|---|
| D000030 | Abortion, Missed |
| D000027 | Abortion, Incomplete |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C042973 | K-Y jelly |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
odorless, colorless gel will be used as a placebo |
|
|
| immediate |
| Pain during uterine aspiration | Pain on visual analogue scale | immediate |
| Jan 22, 2020 |
| Aniline Compounds |
| D000588 | Amines |