Pain
Conditions
Keywords
Misoprostol, IUD insertion, Nulliparous Women, Contraception, Family Planning, IUD insertion in nulliparous women
Brief summary
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.
Detailed description
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.
Interventions
DRUGMisoprostol
400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
DRUGPlacebo
Pills which are identical to the study drug in appearance, taste, and smell.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 14 years old or older * Negative pregnancy test * No prior pregnancies lasting beyond 19 6/7 weeks * Minimum 2 weeks after spontaneous or medical abortion * Minimum 4 weeks post 2nd trimester or surgical abortion * No previous IUD insertions * No PID in last 3 months * No current cervicitis * Willing to follow-up in 1-2 months for an IUD string check
Exclusion criteria
* Active cervical infection * Current pregnancy * Prior pregnancy beyond 19 6/7 weeks gestation * Known uterine anomaly * Fibroid uterus distorting uterine cavity * Copper allergy/Wilson's Disease (for Paragard) * Undiagnosed abnormal uterine bleeding * Cervical or uterine cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perceived Pain on a 100-point Visual Analogue Scale. | Prior to insertion, immediately after insertion, and prior to clinic discharge. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale. | Immediately post IUD insertion | Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult). |
Participant flow
Recruitment details
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.
Pre-assignment details
3 of the 85 enrolled participants were deemed ineligible and not randomized to misoprostol or the placebo group.
Participants by arm
| Arm | Count |
|---|---|
| Misoprostol Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire. | 42 |
| Placebo Pills which are identical to the study drug in appearance, taste, and smell. | 40 |
| Not Randomized Women not eligible to continue to randomization. | 3 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-2 Week IUD Check up | IUD expulsion/removal | 2 | 2 |
| IUD Insertion | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Misoprostol | Placebo | Not Randomized | Total |
|---|---|---|---|---|
| Age, Continuous | 24.1 years STANDARD_DEVIATION 4.3 | 24.1 years STANDARD_DEVIATION 4.6 | NA years | 24.1 years STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 42 participants | 40 participants | 3 participants | 85 participants |
| Sex: Female, Male Female | 42 Participants | 40 Participants | 3 Participants | 85 Participants |
| Sex: Female, Male Male | 0 Participants | 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 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: Prior to insertion, immediately after insertion, and prior to clinic discharge.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Misoprostol | Patient Perceived Pain on a 100-point Visual Analogue Scale. | Pain perceived prior to insertion | 0.5 units on a scale | Standard Deviation 1.2 |
| Misoprostol | Patient Perceived Pain on a 100-point Visual Analogue Scale. | Pain perceived immediately after insertion | 5.8 units on a scale | Standard Deviation 2 |
| Misoprostol | Patient Perceived Pain on a 100-point Visual Analogue Scale. | Pain perceived prior to clinic discharge | 3.2 units on a scale | Standard Deviation 2.2 |
| Placebo | Patient Perceived Pain on a 100-point Visual Analogue Scale. | Pain perceived prior to insertion | 0.8 units on a scale | Standard Deviation 1.7 |
| Placebo | Patient Perceived Pain on a 100-point Visual Analogue Scale. | Pain perceived immediately after insertion | 5.9 units on a scale | Standard Deviation 2 |
| Placebo | Patient Perceived Pain on a 100-point Visual Analogue Scale. | Pain perceived prior to clinic discharge | 3.8 units on a scale | Standard Deviation 2.7 |
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).
Time frame: Immediately post IUD insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Misoprostol | Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale. | 2.2 units on a scale | Standard Deviation 2.2 |
| Placebo | Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale. | 2.5 units on a scale | Standard Deviation 2.2 |