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ABSTRACT: : Although hydrocodone-acetaminophen is commonly used for pain control in first-trimester abortion, the efficacy of oral opioids for decreasing pain has not been established. Our objective was to estimate the effect of hydrocodone-acetaminophen on patient pain perception during first-trimester surgical abortion.
: We conducted a randomized, double-blinded, placebo-controlled trial. Patients (before 11 weeks of gestation) received standard premedication (ibuprofen and lorazepam) and a paracervical block with the addition of 10 mg hydrocodone and 650 mg acetaminophen or placebo 45-90 minutes before surgical abortion. A sample size of 120 was calculated to provide 80% power to show a 15-mm difference (α=0.05) in the primary outcome of pain with uterine aspiration (100-mm visual analog scale). Secondary outcomes were pain at additional time points, satisfaction, side effects, adverse events, and need for additional pain medications.
: There were no significant differences in demographics or baseline pain between groups. There were no differences in pain scores between patients receiving hydrocodone-acetaminophen compared with placebo during uterine aspiration (65.7 mm compared with 63.2 mm, P=.59) or other procedural time points. There were no differences in satisfaction or need for additional pain medications. Patients who received hydrocodone-acetaminophen had more postoperative nausea than those receiving placebo (P=.03) when controlling for baseline nausea. No medication-related adverse events were noted.
: Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea.
: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459.
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Obstetrics and Gynecology 11/2012; 120(5):1060-9. · 4.73 Impact Factor
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ABSTRACT: 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.
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.
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.
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.
Contraception 05/2012; 86(5):443-51. · 2.72 Impact Factor
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ABSTRACT: Despite lack of efficacy data, the majority of first-trimester surgical abortions are performed with a paracervical block. Women may be unnecessarily exposed to a painful injection and potentially noxious medication. Our objective was to estimate the effect of a paracervical block and the effect of gestational age on patient pain perception.
This was a randomized, single-blind trial of patients undergoing abortion receiving paracervical block or sham stratified by gestational age (early: less than 8 weeks of gestation, n=60; late: 8-10 6/7 weeks of gestation, n=60). Premedicated with ibuprofen and lorazepam, all participants received 2 mL 1% buffered lidocaine injected at the tenaculum site followed by a slow, deep injection of 18 mL at four sites (block) or no injection (sham) with a 3-minute wait. The primary outcome was dilation pain (100-mm visual analog scale). Secondary outcomes included pain at additional time points, satisfaction, need for more analgesics, and adverse events.
Full enrollment occurred (n=120). We used intent-to-treat analysis. Demographics did not differ between groups. Paracervical block administration was painful (mean 55 mm compared with sham 30 mm, P<.001) but decreased dilation pain (42 mm compared with 79 mm, P<.001) and aspiration pain (63mm compared with 89 mm, P<.001). These results were consistent for both gestational age strata; however, paracervical block benefit was greater at an earlier gestation. Satisfaction scores with pain control and the procedure were significantly higher in the block group.
Although paracervical block is painful, it reduces first-trimester abortion pain regardless of gestational age, but the benefit on dilation pain was greater at earlier gestations.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094366.
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Obstetrics and Gynecology 05/2012; 119(5):1030-7. · 4.73 Impact Factor
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ABSTRACT: The study was conducted to examine the effects of a 4% intrauterine lidocaine infusion on patient-perceived pain during transcervical sterilization.
This was a randomized, double-blind, placebo-controlled trial. Subjects received standard premedication with 800 mg ibuprofen, 2 mg lorazepam, a 10-mL 1% lidocaine paracervical block and transcervical instillation of 5 mL of either 4% lidocaine or saline 3 min prior to insertion of the hysteroscope. Subjects completed a series of 100-mm visual analog scales to measure their perceived pain at set time points during and after the procedure. Serum lidocaine levels were obtained in a subset of subjects.
Pain scores at all evaluation points did not significantly differ between groups (lidocaine n=29, saline n=29). Mean lidocaine levels did not differ between groups, and no subject demonstrated symptoms of lidocaine toxicity. The highest serum lidocaine level (4022 ng/mL) occurred 20 min after infusion in a lidocaine-treated subject.
Intrauterine lidocaine prior to outpatient transcervical sterilization does not decrease pain.
Contraception 08/2011; 85(3):275-81. · 2.72 Impact Factor
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ABSTRACT: The study was conducted to characterize the relationship between formal sex education and the use and type of contraceptive method used at coital debut among female adolescents.
This study employed a cross-sectional, nationally representative database (2002 National Survey of Family Growth). Contraceptive use and type used were compared among sex education groups [abstinence only (AO), birth control methods only (MO) and comprehensive (AM)]. Analyses also evaluated the association between demographic, socioeconomic, behavioral variables and sex education. Multiple logistic regression with adjustment for sampling design was used to measure associations of interest.
Of 1150 adolescent females aged 15-19 years, 91% reported formal sex education (AO 20.4%, MO 4.9%, AM 65.1%). The overall use of contraception at coitarche did not differ between groups. Compared to the AO and AM groups, the proportion who used a reliable method in the MO group (37%) was significantly higher (p=.03) (vs. 15.8% and 14.8%, respectively).
Data from the 2002 NSFG do not support an association between type of formal sex education and contraceptive use at coitarche but do support an association between abstinence-only messaging and decreased reliable contraceptive method use at coitarche.
Contraception 09/2010; 82(3):236-42. · 2.72 Impact Factor
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ABSTRACT: First-trimester abortions especially cervical dilation and suction aspiration are associated with pain despite various methods of pain control.
Following the guidelines for a Cochrane review, we systematically searched for and reviewed randomized controlled trials comparing methods of pain control in first-trimester surgical abortion at less than 14 weeks gestational age using electric or manual suction aspiration. Outcomes included intra- and postoperative pain, side effects, recovery measures and satisfaction.
We included 40 trials with 5131 participants. Because of heterogeneity, we divided studies into seven groups: Local anesthesia: Data were insufficient to show a clear benefit of a paracervical block (PCB) compared to no PCB. Reported mean pain scores (10-point scale) during dilation and aspiration were improved with carbonated lidocaine [weighted mean difference (WMD), -0.80; 95% confidence interval (CI), -0.89 to -0.71; WMD, -0.96; 95% CI, -1.67 to -0.25], deep injection (WMD, -1.64; 95% CI, -3.21 to -0.08; WMD, 1.00; 95% CI, 1.09 to 0.91), and with adding a 4% intrauterine lidocaine infusion (WMD, -2.0; 95% CI, -3.29 to -0.71; WMD, -2.8; 95% CI, -3.95 to -1.65). PCB with premedication: Ibuprofen and naproxen resulted in small reduction of intra- and postoperative pain. Conscious sedation: The addition of conscious intravenous sedation using diazepam and fentanyl to PCB decreased procedural pain. General anesthesia: Conscious sedation increased intraoperative but decreased postoperative pain compared to general anesthesia (GA) [Peto odds ratio (Peto OR) 14.77 (95%, CI 4.91-44.38) and Peto OR 7.47 (95% CI, 2.2-25.36) for dilation and aspiration, respectively, and WMD -1.00 (95% CI, -1.77 to -0.23) postoperatively). Inhalation anesthetics are associated with increased blood loss (p<0.001). GA with premedication: The cyclooxygenase (COX)-2 inhibitor etoricoxib; the nonselective COX inhibitors lornoxicam, diclofenac and ketorolac IM; and the opioid nalbuphine improved postoperative pain. Nonpharmacological intervention: Listening to music decreased procedural pain. No major complication was observed.
Conscious sedation, GA and some nonpharmacological interventions decreased procedural and postoperative pain, while being safe and satisfactory to patients. Data on the widely used PCB are inadequate to support its use, and it needs to be further studied to determine any benefit.
Contraception 05/2010; 81(5):372-88. · 2.72 Impact Factor
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ABSTRACT: The aim of the study was to identify barriers associated with the failure to return for delayed intrauterine device (IUD) insertion postabortion.
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.
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$1409.50) and those who did not (US$937.50, p=.05).
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.
Contraception 04/2009; 79(3):216-20. · 2.72 Impact Factor
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ABSTRACT: To characterize the relationship between body mass index and sexual behavior, including sexual orientation, age at first intercourse, ever having had sex with a male partner, number of partners, and frequency of intercourse.
This study employed the 2002 National Survey of Family Growth, a cross-sectional, nationally representative database in which women between the ages of 15 years and 44 years were surveyed regarding reproductive health outcomes. Sexual behavior was compared between body mass index groups-normal (less than 25 m/kg2), overweight (25-30 m/kg2), and obese (greater than 30 m/kg2)-using self-reported height and weight. Multiple logistic regression with adjustment for the sampling design was used to measure associations of interest.
Body mass index was not significantly associated with sexual orientation, age at first intercourse, frequency of heterosexual intercourse, and the number of lifetime or current male partners. Overweight women and obese women were more likely to report ever having male sexual intercourse (P<.001). This difference persisted when we adjusted for age as well as type of residence.
With the exception of ever engaging in sexual intercourse with a man, sexual behavior differs little between women of different body mass indices.
Obstetrics and Gynecology 10/2008; 112(3):586-92. · 4.73 Impact Factor
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ABSTRACT: The aim of the study was to evaluate pain and predictors of pain in women undergoing electric (EVA) or manual vacuum aspiration (MVA) for first trimester surgical abortions and to examine how perceptions of pain differ among participants, advocates (participant support person) and physicians.
In this randomized controlled study, women presenting for first trimester abortion underwent standardized EVA or MVA. Participants completed questionnaires, visual analog scales (VAS) and Likert scales for pain. Logistic and linear regression models were used to analyze the data.
Nonwhite women and women who preoperatively expected more pain reported higher procedure-related pain scores. Vacuum source, previous history of abortion, comfort with decision to have an abortion and partner involvement did not affect participant pain scores. In the multivariable analyses, no single factor predicted procedure-associated pain. The advocates perceived that more educated women had less pain. Physicians felt longer procedures and a woman's fear of pelvic examinations caused more pain. Physicians believed women had less pain than the participants reported themselves (p<.001). Only physicians thought that EVA was less painful than MVA (p<.01).
Distinct factors other than vacuum source affect the perception of abortion-related pain. Understanding these factors may help inform counseling strategies aimed at ameliorating pain perception during first trimester abortions.
Contraception 08/2008; 78(2):155-61. · 2.72 Impact Factor
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ABSTRACT: 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.
Contraception 08/2008; 78(1):26-30. · 2.72 Impact Factor
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ABSTRACT: To determine attitudes of in vitro fertilization (IVF) patients toward multifetal pregnancy reduction before and after embryo transfer.
Women seeking IVF consultation were surveyed before and after embryo transfer regarding their attitudes toward multifetal pregnancy reduction.
Thirty-one of 36 subjects completed the initial survey. The mean age was 32.9 years, 93% of subjects were Caucasian, and 61.3% were nulliparous. Most subjects described themselves as "pro-choice" (20 of 31, 64.5%). Overall, 22.6% (7 of 31) stated that they would never consider fetal reduction in a multifetal pregnancy and 77.4% (24 of 31) stated that they would consider multifetal pregnancy reduction. The threshold to consider fetal reduction was triplets. Prochoice subjects were significantly more likely to consider multifetal pregnancy reduction when compared to "prolife" subjects (p <0.01). Twelve of the 31 subjects underwent embryo transfer and completed the second survey. Patient attitude did not change significantly from the time of initial IVF consultation to after embryo transfer.
Overall, women undergoing IVF would consider multifetal pregnancy reduction, and this view did not change after embryo transfer. Pro-choice subjects were more likely to consider multifetal pregnancy reduction.
The Journal of reproductive medicine 07/2007; 52(7):635-8. · 0.87 Impact Factor
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ABSTRACT: To estimate whether progestin type or estrogen dose influences bleeding patterns, adverse effects, or satisfaction with combined oral contraceptives dosed continuously.
This was a randomized, double blind, 4-arm active treatment study. Subjects received either 100 microg levonorgestrel/20 microg ethinyl estradiol (E2) (20LNG group), 100 microg levonorgestrel/30 microg ethinyl E2 (30LNG group), 1,000 microg norethindrone acetate/20 microg ethinyl E2 (20NETA group), or 1,000 microg norethindrone acetate/30 microg ethinyl E2 (30NETA group) for 180 days. Subjects logged bleeding events and adverse effects on a daily menstrual calendar. An exit survey measured satisfaction with bleeding patterns.
One hundred thirty-nine women were enrolled. Patients in the 20NETA and 30NETA arms had significantly more days of amenorrhea than the 30LNG arm in the second 90 days (P < .008). The 30LNG group reported more spotting days than the 20NETA group over the entire study period (P < .008) and the 30NETA group for the second 90 days (P < .008). Only a small number of bleeding days were reported with no differences between groups. No differences in adverse effects between groups were found. Women in the 30LNG arm reported lower levels of satisfaction with their bleeding patterns than the other groups (30LNG compared with 20NETA, P = .01; 30LNG compared with 30NETA, P = .001).
The addition of 10 microg of ethinyl E2 to a 20 microg ethinyl E2 pill containing levonorgestrel or norethindrone acetate did not improve bleeding patterns. During continuous dosing, the use of oral contraceptives containing 1,000 microg norethindrone acetate resulted in more days of amenorrhea and fewer days of spotting than preparations containing 100 microg levonorgestrel.
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Obstetrics and Gynecology 03/2006; 107(3):657-65. · 4.73 Impact Factor
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ABSTRACT: This study was undertaken to determine whether buccal misoprostol improves cervical preparation achieved with laminaria before second-trimester dilation and evacuation procedures.
A randomized, double blind, placebo-controlled trial of preoperative cervical preparation with overnight laminaria and either buccal placebo or 400 microg buccal misoprostol approximately 90 minutes before second-trimester surgical abortion. Block randomization was used to provide balanced enrollment into 2 separate gestational age study groups: early (13-15(6/7)) and mid (16-20(6/7)) second trimester. Surgeons tested maximal cervical dilation by inserting the largest dilator that could be passed through the cervical os without force. Subject demographics and preprocedure symptoms were tracked.
Groups were similar in regard to age, gravity, parity, delivery type, and gestational age. Data were analyzed from 125 women in the 13 to 15(6/7) (30 misoprostol, 32 placebo) and 16 to 20(6/7) (31 misoprostol, 32 placebo) gestational age groups. Overall, misoprostol treatment did not improve the initial mean dilation achieved with laminaria alone in either the 13 to 15(6/7) (46.0 fr +/- 5.0; placebo 45.0 fr +/- 6.2, P = .68) or 16 to 20(6/7) (50.9 fr +/- 5.6, placebo 48.9 fr +/- 5.2, P = .16) groups. However, a subanalysis of gestations 19 weeks or more demonstrated significantly greater dilation in the misoprostol group (53.6 fr fr +/- 5.3, placebo 48.5 fr +/- 5.0, P = .01). Subjects receiving misoprostol reported significantly more cramping than those receiving placebo (13-15(6/7) weeks misoprostol 25/30, 83%; placebo 17/32, 53%, P = .02; 16-20(6/7) week misoprostol 25/31, 81%, placebo 16/32, 50%, P = .02).
Cervical dilation with laminaria is augmented by 400 microg buccal misoprostol in gestations 19 weeks or more, but not in earlier gestations. Misoprostol causes more abdominal cramping.
American journal of obstetrics and gynecology 03/2006; 194(2):425-30. · 3.28 Impact Factor
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ABSTRACT: To study the effects of a 4% intrauterine lidocaine infusion on perceived patient pain in first-trimester abortions.
A randomized, double-blind, placebo-controlled trial of 80 women receiving either a 5-mL 4% lidocaine (n = 40) or saline (n = 40) intrauterine infusion and a standard paracervical block before first-trimester abortion. Women completed a series of 100-mm visual analog scales (anchors: 0 = none, 100 mm = worst imaginable) to measure their perceived pain (anticipated pain, after speculum insertion, after intrauterine infusion, after cervical dilation, after suction aspiration, and 30 minutes postprocedure). Eight women volunteered for serum lidocaine levels after the lidocaine infusion.
Groups were similar in respect to age, parity, prior abortion, ethnicity, gestational age, and level of dysmenorrhea. Pain scores demonstrated a significant difference between groups during cervical dilation (saline 55 mm +/- 26, lidocaine 35 mm +/- 30, P < .01) and during aspiration (saline 71 mm +/- 20, lidocaine 43 mm +/- 30, P < .01). The lidocaine group reported significantly more symptoms (ie, oral numbness and tingling) than the saline group (saline 0/39, lidocaine 16/38, 42%, P < .01). The highest serum lidocaine level recorded was 4.0 microg/mL (lidocaine group). There was no difference in overall satisfaction between the 2 groups.
Compared with paracervical block alone, the addition of a 4% intrauterine lidocaine infusion resulted in a significant reduction in patient perception of pain during first-trimester abortion. Although subjective symptoms of systemic lidocaine effect were common, no subjects demonstrated serum levels consistent with lidocaine toxicity. However, further studies to determine safety are needed.
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Obstetrics and Gynecology 02/2006; 107(2 Pt 1):269-75. · 4.73 Impact Factor
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ABSTRACT: This paper describes the development and evaluation of the Abortion Attributes Questionnaire (AAQ), an instrument designed to assess the perceived importance of specific characteristics of abortion methods. Women receiving medical abortions (n=186) and women who chose surgical procedures (n=118) completed the AAQ. Participants were asked to rate how important each of 21 characteristics would be "when choosing between surgical and medical abortion." Factor analyses revealed that the AAQ consists of four factors and, as subscales, the factors have good internal reliability. The validity of the AAQ was established through discriminant function and analysis and results indicated that three of the four factors predicted choice. Taken together, these findings provide empirical support for the constructs measured by the AAQ.
Journal of Social Issues 04/2005; 61(1):95-107. · 1.96 Impact Factor
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ABSTRACT: Our purpose was to determine whether an interactive medical student contraceptive teaching session results in improved knowledge gain or satisfaction when compared with a standard, didactic lecture.
An interactive lecture was compared with a standard lecture among third-year medical students at Oregon Health and Science University School of Medicine and Medical College of Georgia. Knowledge gain was assessed by comparing correct responses to a posttest with the students' own responses to the same questions given as a pretest before the lecture. Satisfaction with the lecture was assessed on a visual analog scale. Scores and satisfaction ratings were compared within and between lecture groups.
A total of 150 students participated. There was a significant increase in test scores within both the interactive and standard groups ( P < .0001 for both groups). The change in scores did not differ significantly between the groups ( P = .087). Although overall satisfaction was significantly greater with the standard lecture ( P = .004), it was high with both lectures.
Knowledge gain with the interactive lecture was equivalent to that with the standard lecture. Satisfaction with both learning formats was high.
American Journal of Obstetrics and Gynecology 11/2004; 191(5):1788-92. · 3.47 Impact Factor
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ABSTRACT: To study the effects of an intrauterine lidocaine infusion on perceived patient pain in first-trimester abortions and to measure serum lidocaine levels.
A randomized, double-blind, placebo control trial of 80 women receiving either a 10-mL 1% lidocaine (n = 40) or saline (n = 40) intrauterine infusion and a standard paracervical block before first-trimester abortion was undertaken. Women completed a series of 100-mm visual analogue scales to measure their perceived pain (anticipated pain, after speculum insertion, after intrauterine infusion, after cervical dilation, after suction aspiration, and 30 minutes after procedure). Twenty women (10 in each group) volunteered for serum lidocaine levels at 10, 20, 30, 45, and 60 minutes after the lidocaine infusion.
Groups were similar in respect to age, parity, prior abortion, ethnicity, gestational age, level of dysmenorrhea, and complications. Pain scores by visual analogue scale demonstrated no significant difference between groups at any time point during the procedure; in particular, pain during aspiration (saline infusion 51 +/- 26 mm, lidocaine infusion 47 +/- 28 mm; P =.51). Peak serum levels occurred at approximately 10 minutes after lidocaine infusion. The highest level recorded (lidocaine group) was 2.5 microg/mL (toxicity more than 5 microg/mL).
Compared with paracervical block alone, the addition of a 1% intrauterine lidocaine infusion resulted in no improvement in patient perception of pain during first-trimester abortion. No subjects demonstrated symptoms or serum levels of lidocaine toxicity.
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Obstetrics and Gynecology 07/2004; 103(6):1267-72. · 4.73 Impact Factor
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ABSTRACT: In asymptomatic patients with an early gestation located in a noncommunicating rudimentary horn, methotrexate may provide another treatment option or act as a useful adjunct to surgical intervention. We present a case of a successful pregnancy termination of a gestation located in a noncommunicating rudimentary horn with subsequent elective laparoscopic resection.
American Journal of Obstetrics and Gynecology 10/2003; 189(3):886-7. · 3.47 Impact Factor
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ABSTRACT: This paper examines women's acceptability of and experiences with manual vacuum aspiration (MVA) as compared with electric vacuum aspiration (EVA) for first trimester abortion. Women requesting pregnancy terminations were randomly assigned to either MVA (n = 64) or EVA (n = 63). Participants completed questionnaires before and after their abortions and approximately 2-4 weeks later. We observed some differences by group in participants' ratings of the importance of method characteristics and in their perceptions of their abortion methods after their abortions. The two groups did not, however, differ in their reports of pain, anxiety or bleeding or in the acceptability of their method.
Contraception 04/2003; 67(3):207-12. · 2.72 Impact Factor
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ABSTRACT: The purpose of this study is to compare bleeding patterns and acceptability of a contraceptive regimen of combined 20 microg ethinyl estradiol/100 microg levonorgestrel taken with and without a hormone-free interval. Thirty-two women desiring oral contraception were randomized to six 28-day cycles (standard group) or 168 days without a pill-free interval (continuous group). Participants kept a daily bleeding calendar documenting bleeding events (none, spotting or required sanitary protection) and side effects (headache, nausea, breast tenderness, depression, premenstrual syndrome and bloating). Primary outcome was number of bleeding days. Secondary outcomes included bleeding days requiring sanitary protection, amenorrhea, patient acceptability of bleeding patterns, method satisfaction and affective side effects. There were no differences in the baseline characteristics of the two groups. Although total bleeding days were fewer in the continuous group (mean = 25.9 vs. 34.9 days), this result did not reach statistical significance. However, women in the continuous group reported significantly fewer bleeding days that required protection (18.4 vs. 33.8 days, p < 0.01), and were more likely to have amenorrhea. Although both groups reported a high level of satisfaction with bleeding patterns and side effect profiles, women in the continuous group reported significantly fewer days of bloating (0.7 vs. 11.1 days, p = 0.04), and menstrual pain (1.9 vs. 13.3 days, p < 0.01). Continuous use of 20 microg ethinyl estradiol/100 microg levonorgestrel is associated with less bleeding requiring protection, and more amenorrhea than standard administration. Taken with or without a hormone-free interval, this oral contraceptive formulation is highly acceptable with regard to bleeding patterns and side effect profile. The continuous group had fewer light and moderate bleeding days, less bloating and menstrual pain. For patients who are seeking these results, this method may be more desirable.
Contraception 01/2003; 67(1):9-13. · 2.72 Impact Factor
