Contraception
Conditions
Keywords
intrauterine device, cervical dilation, nulliparous women, pain management
Brief summary
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.
Detailed description
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.
Interventions
DRUGMisoprostol
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
DIETARY_SUPPLEMENTMagnesium Oxide
Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation) * Ages 18-45 * Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette
Exclusion criteria
* Pregnancy occurring less than 6 weeks from time of presentation * History of prior intrauterine device placement * History of Mullerian tract anomalies * History of uterine surgery * Allergy or intolerance to misoprostol or other prostaglandin * Pelvic inflammatory disease (current or within the past 3 months) * Sexually transmitted diseases (current) * Puerperal or postabortion sepsis (current or within the past 3 months) * Purulent cervicitis (current) * Undiagnosed abnormal vaginal bleeding * Malignancy of the genital tract * Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion * Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). | Time of IUD insertion | Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS). | At time of IUD insertion | Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right). |
Countries
United States
Participant flow
Recruitment details
February 2007-March 2010 in general OB/GYN clinic at an academic hospital
Pre-assignment details
Women desiring IUD placement who were nulliparous were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Active Drug (Misoprostol) 400mcg of buccal misoprostol 90 minutes prior to IUD insertion | 20 |
| Placebo Placebo buccal 90 minutes prior to IUD insertion. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Active Drug (Misoprostol) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age Continuous | 27 years STANDARD_DEVIATION 6 | 25 years STANDARD_DEVIATION 5 | 26 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).
Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right).
Time frame: Time of IUD insertion
Population: Intent to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Drug (Misoprostol) | The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). | 24 mm | Standard Deviation 19 |
| Placebo | The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). | 29 mm | Standard Deviation 21 |
Secondary
Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).
Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right).
Time frame: At time of IUD insertion
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Drug (Misoprostol) | Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS). | 65 mm | Standard Deviation 21 |
| Placebo | Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS). | 55 mm | Standard Deviation 21 |