13 research outputs found
Safety, efficacy and patient acceptability of the contraceptive and non-contraceptive uses of the LNG-IUS
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 ΞΌg daily. It is highly effective, with a typical-use first year pregnancy rate of 0.1% β 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 deviceβs 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
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Immediate versus delayed IUD insertion after uterine aspiration.
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.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.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.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.)
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Immediate versus delayed IUD insertion after uterine aspiration.
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.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.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.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.)
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Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial.
To evaluate if ibuprofen 800mg reduces pain with intrauterine device (IUD) insertion among U.S. women.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.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.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
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Long-Acting Reversible Contraception Counseling and Use for Older Adolescents and Nulliparous Women
PurposeThe majority of pregnancies during adolescence are unintended, and few adolescents use long-acting reversible contraception (LARC) due in part to health care providers' misconceptions about nulliparous women's eligibility for the intrauterine device. We examined differences in LARC counseling, selection, and initiation by age and parity in a study with a provider's LARC training intervention.MethodsSexually active women aged 18-25 years receiving contraceptive counseling (n = 1,500) were enrolled at 20 interventions and 20 control clinics and followed for 12 months. We assessed LARC counseling and selection, by age and parity, with generalized estimated equations with robust standard errors. We assessed LARC use over 1 year with Cox proportional hazards models with shared frailty for clustering.ResultsWomen in the intervention had increased LARC counseling, selection, and initiation, with similar effects among older adolescent and nulliparous women, and among young adult and parous women. Across study arms, older adolescents were as likely as young adults to receive LARC counseling (adjusted odds ratio [aOR] = .85; 95% confidence interval [CI]: .63-1.15), select LARC (aOR = .86; 95% CI: .64-1.17), and use LARC methods (adjusted hazard ratio [aHR] = .94; 95% CI: .69-1.27). Nulliparous women were less likely to receive counseling (aOR = .57; 95% CI: .42-.79) and to select LARC (aOR = .53; 95% CI: .37-.75) than parous women, and they initiated LARC methods at lower rates (aHR = .65; 95% CI: .48-.90). Nulliparous women had similar rates of implant initiation but lower rates of intrauterine device initiation (aHR = .59; 95% CI: .41-.85).ConclusionsContinued efforts should be made to improve counseling and access to LARC methods for nulliparous women of all ages
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Effect of "observed start" vs. traditional "Sunday start" on hormonal contraceptive continuation rates after medical abortion.
This study was conducted to determine whether early initiation of combined hormonal contraception under direct clinical observation following successful medical abortion increases continuation rates with the method compared to traditional "Sunday start."Women enrolled in a multicenter medical abortion trial with mifepristone and misoprostol who requested combined hormonal contraception (pill, ring or patch) following medical abortion were recruited. Women were randomized to initiate the method under supervision either at the 1-week medical abortion follow-up visit ("observed start") or at the first Sunday following this visit ("Sunday start"). Primary outcome was continuation of the chosen method at 6 weeks.Of the 1128 women in the primary trial, 261 subjects enrolled in this substudy and 36/261 (13.8%) were lost to follow-up. There was no significant difference in method continuation at 6 weeks [observed start 108/114 (94.7%), Sunday start 101/111 (91.0%, p=.27].Short-term continuation rates among those choosing hormonal contraception following medical abortion are high and are not significantly improved by initiating the method at the time of the first follow-up visit
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Effect of "observed start" vs. traditional "Sunday start" on hormonal contraceptive continuation rates after medical abortion.
This study was conducted to determine whether early initiation of combined hormonal contraception under direct clinical observation following successful medical abortion increases continuation rates with the method compared to traditional "Sunday start."Women enrolled in a multicenter medical abortion trial with mifepristone and misoprostol who requested combined hormonal contraception (pill, ring or patch) following medical abortion were recruited. Women were randomized to initiate the method under supervision either at the 1-week medical abortion follow-up visit ("observed start") or at the first Sunday following this visit ("Sunday start"). Primary outcome was continuation of the chosen method at 6 weeks.Of the 1128 women in the primary trial, 261 subjects enrolled in this substudy and 36/261 (13.8%) were lost to follow-up. There was no significant difference in method continuation at 6 weeks [observed start 108/114 (94.7%), Sunday start 101/111 (91.0%, p=.27].Short-term continuation rates among those choosing hormonal contraception following medical abortion are high and are not significantly improved by initiating the method at the time of the first follow-up visit
Evidence for Acyl-Ghrelin Modulation of Growth Hormone Release in the Fed State
Context: The timing and frequency of GH secretory episodes is regulated by GHRH and somatostatin. This study provides evidence for amplification of these GH pulses by endogenous acyl-ghrelin