Paula H. Bednarek

Immediate versus Delayed IUD Insertion after Uterine Aspiration

BACKGROUND Intrauterine devices (IUDs) provide highly effective, reversible, long-term contraception that is appropriate for many women after first-trimester uterine aspiration. However, the effects of immediate versus delayed IUD insertion after uterine aspiration on rates of complications and IUD use are uncertain. METHODS We performed a randomized noninferiority trial involving women undergoing uterine aspiration for induced or spontaneous abortion at 5 to 12 weeks of gestation who desired an IUD. Subjects were randomly assigned (in a 5:6 ratio) to IUD insertion immediately after the procedure or 2 to 6 weeks afterward (delayed insertion). The primary outcome was the rate of IUD expulsion 6 months after IUD insertion; an expulsion rate 8 percentage points higher in the immediate-insertion group was defined as inferior. RESULTS Among 575 women who underwent randomization, an IUD was inserted in 100% (258 of 258) of the women in the immediate-insertion group and in 71.3% (226 of 317) of those in the delayed-insertion group (difference, 28.7 percentage points; 95% confidence interval [CI], 23.7 to 33.7). The 6-month expulsion risk was 5.0% (13 of 258 women) after immediate insertion and 2.7% (6 of 226) after delayed insertion (difference, 2.3 percentage points; 95% CI, -1.0 to 5.8), which was consistent with the predefined criterion for noninferiority. Six-month rates of IUD use were higher in the immediate-insertion group (92.3%, vs. 76.6% after delayed insertion; P<0.001). Adverse events were rare and did not differ significantly between groups. No pregnancies occurred in the immediate-insertion group; five occurred in the delayed-insertion group (P=0.07), all in women who never received an IUD. CONCLUSIONS The 6-month rate of expulsion of an IUD after immediate insertion was higher than but not inferior to that after delayed insertion. Immediate insertion resulted in higher rates of IUD use at 6 months, without an increased risk of complications. (Funded by the Susan Thompson Buffett Foundation; ClinicalTrials.gov number, NCT00562276.).

Barriers associated with the failure to return for intrauterine device insertion following first-trimester abortion

BACKGROUND The aim of the study was to identify barriers associated with the failure to return for delayed intrauterine device (IUD) insertion postabortion. STUDY DESIGN This study had two components: (a) a retrospective cohort study of women who chose an IUD as their postabortion contraceptive method to compare characteristics of those who did and did not receive a device within 6 months of the procedure and (b) a prospective survey of women intending IUD use postabortion to assess actual IUD use at 6 weeks, barriers to access and attitudes on insertion timing. RESULTS Of the 500 abortion patient charts available for review during the study period, 53 women intended IUD use postabortion. At 6 months, only 32% intending an IUD received one, and there were no significant demographic differences between the groups. For the prospective portion, the response rate at 6 weeks was 54% (27/50), with only 26% (7/27) of responders reporting IUD insertion by this time. The principal reported barrier to IUD insertion was time needed for an additional visit (41%). Most women (67%) desired immediate insertion and believed that they would be more likely to have an IUD inserted if it is performed immediately postabortion (63%). Monthly income was the only statistically significant difference between those who responded to the 6-week follow-up (US

Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: A randomized controlled trial

1409.50) and those who did not (US

Safety, efficacy and patient acceptability of the contraceptive and non-contraceptive uses of the LNG-IUS

937.50, p=.05). CONCLUSION A significant number of women that express a preference for IUD use after first-trimester abortion do not return to obtain a device. Most would prefer to have the option of immediate insertion.

Adolescent experience with intrauterine device insertion and use: A retrospective cohort study

OBJECTIVE: Mifepristone and oral misoprostol are typically used for medical abortion in women up to 49 days of gestation, with a 36- to 48-hour interval between the medications. Alternative routes of misoprostol administration allow for use beyond 49 days of gestation. We designed this randomized, noninferiority trial to compare the efficacy, adverse effects, and acceptability of misoprostol 800 mcg vaginally administered simultaneously with, or 24 hours after, mifepristone 200 mg orally for abortion in women up to 63 days of gestation. METHODS: The 1,128 participants swallowed mifepristone 200 mg and were then randomized to self-administer misoprostol intravaginally immediately in the office (group 1) or 24 hours later at home (group 2). Subjects returned for an evaluation, including transvaginal ultrasonography, 7±1 days after initiating treatment. Women who had not aborted were offered a second dose of misoprostol and returned for another evaluation in approximately 1 week. A phone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication. RESULTS: The complete abortion rate for group 1 (95.1%, 95% confidence interval [CI] 93.0–96.8%) was statistically noninferior to that for group 2 (96.9%, 95% CI 95.1–98.2%) (P=.003). The abortion rates between groups did not significantly differ by gestational age. Adverse effects were mostly similar, although nausea, diarrhea, and warmth or chills were significantly more common in group 1. CONCLUSION: Mifepristone 200 mg and misoprostol 800 mcg vaginally used simultaneously is as effective for abortion as compared with regimens using a 24-hour dosing interval. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00269568 LEVEL OF EVIDENCE: I

Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial

Intrauterine devices (IUDs) provide highly effective, long-term, safe, reversible contraception, and are the most widely used reversible contraceptive method worldwide. The levonorgestrel-releasing intrauterine system (LNG-IUS) is a T-shaped IUD with a steroid reservoir containing 52 mg of levonorgestrel that is released at an initial rate of 20 μg daily. It is highly effective, with a typical-use first year pregnancy rate of 0.1% – similar to surgical tubal occlusion. It is approved for 5 years of contraceptive use, and there is evidence that it can be effective for up to 7 years of continuous use. After removal, there is rapid return to fertility, with 1-year life-table pregnancy rates of 89 per 100 for women less than 30 years of age. Most users experience a dramatic reduction in menstrual bleeding, and about 15% to 20% of women become amenorrheic 1 year after insertion. The device’s strong local effects on the endometrium benefit women with various benign gynecological conditions such as menorrhagia, dysmenorrhea, leiomyomata, adenomyosis, and endometriosis. There is also evidence to support its role in endometrial protection during postmenopausal estrogen replacement therapy, and in the treatment of endometrial hyperplasia.

The effect of nitroprusside on IUD insertion experience in nulliparous women: a pilot study

BACKGROUND Adolescents contribute disproportionately to the epidemic level of unintended pregnancy in the USA. Intrauterine devices (IUDs) are highly effective but underutilized in this age group. STUDY DESIGN We searched our electronic clinic database to identify females ≤ 19 years old who underwent attempted IUD insertion between January 2007 and June 2009. This retrospective cohort study primarily compared the insertion and postinsertion experiences between nulliparous and parous teens. RESULTS Of the 307 charts reviewed, the majority of subjects were white (73.4%) and nulliparous (77.5%), with a median age of 18 years (range 15-19). The vast majority (96.4%, 296/307) had a successful IUD insertion upon first attempt; all of the 11 unsuccessful IUD insertion attempts were among nulliparous teens. Follow-up was available for 56% (172/307). During the first 12 months of use, there were 2.9% (5/172) IUD expulsions and 24.4% (42/172) removals, with no differences between nulliparous and parous teens. IUD continuation at 6 months was 83.3%. Pelvic inflammatory disease was diagnosed in 4.6% (8/172) of post-IUD insertions. There were no pregnancies reported in those teens with IUD continuation, while six were reported in subjects who underwent IUD removal. Independent predictors of IUD discontinuation were a history of chronic pelvic pain or dysmenorrhea, and bleeding and/or pain complaints at any post-IUD visit. CONCLUSIONS Overall, adolescents experience minimal complications with IUD use, with similar rates of successful insertion as adults. IUD discontinuation rates were not significantly different between nulliparous and parous teens. While discontinuation was higher than reported in adults, it was lower than reported among teens using other forms of contraception.

Comparison of interventions for pain control with tenaculum placement: a randomized clinical trial.

OBJECTIVE To evaluate if ibuprofen 800mg reduces pain with intrauterine device (IUD) insertion among U.S. women. STUDY DESIGN We conducted a randomized, double-blind, placebo-controlled trial of women undergoing IUD insertion approximately 2-6weeks following first-trimester uterine aspiration. Subjects were randomized to receive ibuprofen 800mg or placebo 30-45min prior to IUD insertion. A 100-mm visual analog scale (VAS) was administered to measure pain after speculum insertion (baseline) and immediately following IUD insertion. RESULTS A total of 202 women were enrolled, with 101 randomized to each group (ibuprofen or placebo). Sociodemographic characteristics and baseline VAS scores were similar between groups. The median pain score with IUD insertion was 41.5mm in the placebo group and 38.0mm in the ibuprofen group (p=.50). Mean and median pain scores did not differ between placebo and ibuprofen when nulliparous and parous women were analyzed independently. Overall, median pain scores were 17.5mm higher in nulliparous women than parous women (p=.004). Median pain scores did not differ by age, IUD-type, history of dysmenorrhea or time since aspiration. CONCLUSIONS Administration of ibuprofen 800mg prior to IUD insertion does not reduce pain associated with the procedure for U.S. women. Overall, nulliparous women report more pain with IUD insertion than multiparous women.

The effect of nitroglycerin on the IUD insertion experience in nulliparous women: a pilot study.

BACKGROUND Concern about pain during placement of an intrauterine device (IUD) represents a barrier to use, especially among nulliparous women. We hypothesized that nitroprusside gel applied intracervically prior to IUD placement would reduce insertion-related pain. STUDY DESIGN We performed a randomized, double-blinded, placebo-controlled pilot study to evaluate the efficacy and tolerability of 10-mg nitroprusside gel (1 mL) or identical placebo gel applied intracervically in nulliparous women immediately prior to IUD placement. Subjects completed a series of 100-mm visual analogue scales at several time points. The primary outcome was subject-reported pain with IUD insertion. Secondary outcomes included provider-reported ease of insertion, subject-reported pain at other time points, side effects, adverse events and need for additional dilation. RESULTS A total of 24 women were randomized. Baseline characteristics were similar between groups. The mean pain score with IUD deployment was 73 mm (SD 17 mm) in the placebo group and 59 mm (SD 26 mm) in the nitroprusside group (p=.15). There was no difference in ease of insertion reported by providers. Two subjects required dilation, one in each group. There were two vasovagal reactions in the nitroprusside group and none in the placebo group. CONCLUSIONS Intracervical administration of 10-mg nitroprusside gel immediately prior to IUD insertion does not appear to provide a clinically relevant improvement in patient-reported pain with IUD insertion among nulliparous women.

Blood loss at the time of first-trimester surgical abortion in anticoagulated women

OBJECTIVE Although previous studies have demonstrated that a variety of local anesthetics are effective to decrease pain associated with tenaculum placement, no studies directly compare an injection with a topical anesthetic. The objective of this study was therefore to compare mean pain scores with tenaculum placement after an intracervical lidocaine injection or topical lidocaine gel. STUDY DESIGN A randomized, single-blinded trial of women presenting for office gynecologic procedures that required a tenaculum. Women aged 18 years or older were randomized to receive either a 1% lidocaine intracervical injection or topical application of 2% lidocaine gel to the cervix immediately prior to tenaculum placement. The primary outcome was pain at the time of tenaculum placement, measured on a 100 mm Visual Analog Scale. Secondary outcomes included pain with the intervention and satisfaction with tenaculum placement. RESULTS Seventy-four women were enrolled and randomized; 35 subjects in each group met criteria for analysis. The two groups had similar socio-demographic characteristics. Women who received the injection had lower mean pain levels at tenaculum placement [12.3 mm (S.D. 17.4 mm) versus 36.6 mm (S.D. 23.0 mm), p<.001] but higher mean pain levels with study drug application [20.4 mm (S.D. 19.4 mm) versus 5.9 mm (S.D. 8.6 mm), p<.001]. Satisfaction with tenaculum placement was similar for the two groups. CONCLUSION Mean pain with tenaculum placement is lower after receiving a lidocaine injection than after receiving a topical lidocaine gel. Satisfaction with tenaculum placement is similar with both interventions.