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The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.
The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Experimental | Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire. |
|
| Placebo | Placebo Comparator | Pills which are identical to the study drug in appearance, taste, and smell. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perceived Pain on a 100-point Visual Analogue Scale. | Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge. | Prior to insertion, immediately after insertion, and prior to clinic discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale. | Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult). | Immediately post IUD insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eve Espey, MD/MPH | University of New Mexico Department of Obstetrics and Gynecology | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21527040 | Derived | Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104. |
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3 of the 85 enrolled participants were deemed ineligible and not randomized to misoprostol or the placebo group.
The study design is double-blind randomized controlled trial in which nulliparous women requesting an IUD were randomized to 400 mcg of buccal misoprostol or placebo 2-8 hours before insertion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol | Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire. Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion. |
| FG001 | Placebo | Pills which are identical to the study drug in appearance, taste, and smell. Placebo: Pills which are identical to the study drug in appearance, taste, and smell. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IUD Insertion |
|
| ||||||||||||||||||
| 1-2 Week IUD Check up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol | Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire. |
| BG001 | Placebo | Pills which are identical to the study drug in appearance, taste, and smell. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale. | Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult). | Posted | Mean | Standard Deviation | units on a scale | Immediately post IUD insertion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Misoprostol | Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eve Espey, MD, MPH, Principle Investigator | University of New Mexico | 505-272-6372 | eespey@salud.unm.edu |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Placebo | Drug | Pills which are identical to the study drug in appearance, taste, and smell. |
|
| NOT COMPLETED |
|
|
| BG002 | Not Randomized | Women not eligible to continue to randomization. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Patient Perceived Pain on a 100-point Visual Analogue Scale. | Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge. | Posted | Mean | Standard Deviation | units on a scale | Prior to insertion, immediately after insertion, and prior to clinic discharge. |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | Placebo: Pills which are identical to the study drug in appearance, taste, and smell. | 0 | 40 | 0 | 40 |
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Pain perceived prior to clinic discharge |
|