Contraception
Conditions
Keywords
IUD insertion, nulliparous women, contraception, family planning, IUD insertion in nulliparous women
Brief summary
Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
Detailed description
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization\[1\], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. 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 give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.
Interventions
DRUGMisoprostol
400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
DRUGPlacebo
Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit
Sponsors
Emory University
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 * negative pregnancy test * no prior pregnancy beyond 19 6/7 weeks * no pelvic inflammatory disease in last 3 months * no current cervicitis * willing to follow up in 1-2 months
Exclusion criteria
* active cervical infection * current pregnancy * prior pregnancy beyond 19 6/7 weeks * uterine anomaly * fibroid uterus distorting uterine cavity * copper allergy or wilson's disease for ParaGard * undiagnosed abnormal uterine bleeding * cervical or uterine cancer * sepsis associated with the most recent pregnancy * current breast cancer for levonogestrel IUD * inflammatory bowel disease * allergy to misoprostol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale | assessed immediately post IUD insertion | The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD | assessed immediately after IUD insertion | — |
| Time for Insertion Procedure | assessed immediately after IUD insertion | — |
| Patient Perceived Pain on a 100 Point Visual Analogue Scale | immediately after insertion | The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain). |
| Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women | assessed immediately following insertion | — |
| Need for Additional Pain Medications After Insertion of the IUD | assessed one week after insertion | — |
| Acceptability of Discomfort Associated With Insertion | assessed at one week after insertion and at one month after insertion | — |
Countries
United States
Participant flow
Recruitment details
Enrollment occurred at a faculty practice clinic affiliated with Emory University.
Pre-assignment details
Seventy-eight nulliparous women were enrolled, and 71 completed the study. Five dropped out prior to randomization and method insertion choosing other birth control options.
Participants by arm
| Arm | Count |
|---|---|
| Misoprostol Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit | 37 |
| Placebo Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit | 36 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | failed insertion | 2 | 0 |
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 | 36 Participants | 37 Participants | 73 Participants |
| Age, Continuous | 25.5 years STANDARD_DEVIATION 0.554 | 26.05 years STANDARD_DEVIATION 0.554 | 25.775 years STANDARD_DEVIATION 0.554 |
| Region of Enrollment United States | 36 participants | 37 participants | 73 participants |
| Sex: Female, Male Female | 36 Participants | 37 Participants | 73 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 / 37 | 0 / 36 |
| serious Total, serious adverse events | 0 / 37 | 0 / 36 |
Outcome results
Primary
Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale
The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).
Time frame: assessed immediately post IUD insertion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Misoprostol | Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale | 21 units on a scale |
| Placebo | Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale | 21 units on a scale |
Secondary
Acceptability of Discomfort Associated With Insertion
Time frame: assessed at one week after insertion and at one month after insertion
Population: Data were not collected for this outcome measure. The follow-up participant questionnaires developed for this study were piloted prior to study initiation and this question was removed for clarity, to focus on the primary study aims, and to reduce participant burden.
Secondary
Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women
Time frame: assessed immediately following insertion
Population: Data were not collected for this outcome measure. The participant questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about prior pregnancies) were removed for clarity, to focus on the primary study aims, and to reduce participant burden.
Secondary
Need for Additional Pain Medications After Insertion of the IUD
Time frame: assessed one week after insertion
Population: Data were not collected for this outcome measure. The follow-up questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about medication use) were removed for clarity, to focus on the primary study aims, and to reduce participant burden.
Secondary
Patient Perceived Pain on a 100 Point Visual Analogue Scale
The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).
Time frame: immediately after insertion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Misoprostol | Patient Perceived Pain on a 100 Point Visual Analogue Scale | 46 units on a scale |
| Placebo | Patient Perceived Pain on a 100 Point Visual Analogue Scale | 34 units on a scale |
Secondary
The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD
Time frame: assessed immediately after IUD insertion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Misoprostol | The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD | 7 participants |
| Placebo | The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD | 3 participants |
Secondary
Time for Insertion Procedure
Time frame: assessed immediately after IUD insertion
Population: Data were not collected for this outcome measure. The provider questionnaire developed for this study was piloted prior to study initiation and this question was removed for clarity and to focus on the primary study aims.