Nonviable Pregnancy
Conditions
Keywords
manual vacuum aspiration, missed abortion, incomplete abortion, nonviable pregnancy, topical lidocaine
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.
Interventions
DRUGLidocaine
2% Lidocaine gel
DRUGPlacebo gel
odorless, colorless gel will be used as a placebo
Sponsors
Women and Infants Hospital of Rhode Island
Bridgeport Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain during intracervical block | immediate | Pain on visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during tenaculum placement | immediate | Pain on visual analogue scale |
| Pain during cervical dilation | immediate | Pain on visual analogue scale |
| Pain during uterine aspiration | immediate | Pain on visual analogue scale |
Other
| Measure | Time frame |
|---|---|
| Complications | 1 hour after procedure |
Countries
United States
Outcome results
None listed