Contraception
Conditions
Keywords
IUD insertion, Nulliparous women, Contraception, Family Planning, IUD insertion in nulliparous women
Brief summary
The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.
Detailed description
Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.
Interventions
DRUGMisoprostol
400 micrograms inserted vaginally or buccally, 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 Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 years old or older * negative pregnancy test * no prior pregnancies beyond 14 6/7 weeks * no PID in last 3 months * no current cervicitis * be willing to follow-up in 1-2 months for an IUD string check.
Exclusion criteria
* active cervical infection * current pregnancy * prior pregnancy beyond 14 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 |
|---|---|---|
| Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) | Immediately post IUD insertion | VAS (anchors: 0 = extremely easy, 100 mm= impossible) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | prior to insertion, immediately after insertion, and prior to clinic discharge | VAS; anchors: 0 =none, 100 mm= worst imaginable |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from July 2009 to November 2010. All IUD insertions occurred at the University of Utah Ob/Gyn clinic.
Pre-assignment details
Participants had an initial study visit where the consent was signed and they were given misoprostol or placebo to take at home. Participants and providers were blinded to the treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Misoprostol Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. | 54 |
| Placebo Pills which are identical to the study drug in appearance, taste, and smell. | 54 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 3 |
Baseline characteristics
| Characteristic | Placebo | 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 | 54 Participants | 54 Participants | 108 Participants |
| Age, Continuous | 24.8 years STANDARD_DEVIATION 4.2 | 24.6 years STANDARD_DEVIATION 3.8 | 24.7 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 54 participants | 54 participants | 108 participants |
| Sex: Female, Male Female | 54 Participants | 54 Participants | 108 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 / 54 | 0 / 51 |
| serious Total, serious adverse events | 0 / 54 | 0 / 51 |
Outcome results
Primary
Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)
VAS (anchors: 0 = extremely easy, 100 mm= impossible)
Time frame: Immediately post IUD insertion
Population: 2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Misoprostol | Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) | 25.1 units on a scale | Standard Deviation 3.5 |
| Placebo | Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS) | 27.4 units on a scale | Standard Deviation 3.5 |
p-value: 0.64t-test, 2 sided
Secondary
Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)
VAS; anchors: 0 =none, 100 mm= worst imaginable
Time frame: prior to insertion, immediately after insertion, and prior to clinic discharge
Population: 2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Misoprostol | Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | prior to insertion | 17.1 units on a scale | Standard Deviation 3.5 |
| Misoprostol | Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | immediately after insertion | 58.4 units on a scale | Standard Deviation 3.3 |
| Misoprostol | Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | prior to clinic discharge | 35.1 units on a scale | Standard Deviation 3.4 |
| Placebo | Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | prior to insertion | 4.8 units on a scale | Standard Deviation 2 |
| Placebo | Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | immediately after insertion | 56.9 units on a scale | Standard Deviation 3 |
| Placebo | Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS) | prior to clinic discharge | 27.5 units on a scale | Standard Deviation 2.4 |