Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial.

OBJECTIVES: Our objective was to evaluate two different aspects of the paracervical block (PCB) technique for first trimester surgical abortion, to compare a 3-min wait prior to cervical dilation to no wait and to compare four-site with two-site injection. STUDY DESIGN: We conducted two consecutive randomized, single-blinded noninferiority trials. In the first trial, women <11 weeks gestational age received a 20-mL 1% buffered lidocaine four-site PCB with either a 3-min wait between PCB injection and dilation or no wait. In the second trial, we compared a four-site with a two-site PCB. We evaluated dilation pain [100-mm visual analogue scale (VAS)] as the primary outcome. Secondary outcomes included pain at additional time points, anxiety, satisfaction and adverse events. RESULTS: Both trials fully enrolled (total n=332). Results were inconclusive as to whether no wait was noninferior to waiting 3-min prior to cervical dilation for dilation pain [VAS: 63 mm (SD, 24 mm) vs. 56 mm (SD, 32mm)] and as to whether a two-site PCB was noninferior to a four-site block [VAS: 68 mm (SD, 21 mm) vs. 60 mm (SD, 30 mm)]. Noninferiority analysis was inconclusive because the confidence interval of the mean pain score difference between groups included the predefined inferiority margin of 13-mm pain difference. Superiority analysis showed the four-site PCB to be superior to the two-site PCB. CONCLUSION: It remained inconclusive whether a 3-min wait time between PCB and cervical dilation provides noninferior pain control for first trimester surgical abortion. However, a four-site PCB appeared to be superior to a two-site PCB. IMPLICATIONS: It remained inconclusive whether a 3-min wait time between PCB and cervical dilation or using a two-site instead of a four-site PCB provided noninferior pain control for first trimester surgical abortion. This study did not assess whether the combination of the two separate factors provides additive benefit.

Intrauterine device placement at 3 versus 6 weeks postpartum: a randomized trial.

OBJECTIVE: To investigate whether early placement of an intrauterine device (IUD) at 3 weeks after delivery, compared to placement at 6 weeks, is associated with greater use at 3 months postpartum. STUDY DESIGN: This prospective randomized, controlled trial enrolled inpatient postpartum women intending to use intrauterine contraception. Participants were assigned to an early (3 week) or standard (6 week) postpartum visit with IUD placement and were followed for 6 months. We used transvaginal ultrasonography to confirm placement and measure uterine dimensions. We measured pain with IUD insertion and satisfaction with IUD timing using 100-mm visual analog scales. Data were analyzed based on randomization and actual timing of insertion (18-24 vs. 39-45 days). RESULTS: Between February 2012 and December 2013, 201 subjects were enrolled (early=101; standard=100). Most participants returned for IUD placement as scheduled; 70.1% (53/75) in the early group, 74.3% (58/78) in the standard group (p=.06). IUD use did not differ between groups at 3 months (73/100, 73.0% and 73/97, 75.3%, respectively, p=.72) or 6 months (80.3% and 82.8%, p=.71) amongst those women for whom follow-up was available. Women randomized to 6-week insertion were more likely to have resumed intercourse prior to the IUD appointment (15/64, 23.4% vs. 5/68, 7.3%, p=.01). Pain with insertion (19.9 vs. 25.1, respectively, p=.21) and satisfaction (89.6 vs. 93.4, respectively, p=.23) did not vary based on actual timing of insertion. CONCLUSION: Offering IUD placement at 3 weeks postpartum compared to standard scheduling at 6 weeks does not result in increased use at 3 months. However, early IUD placement is acceptable to women and without increased pain. IMPLICATIONS: This study demonstrates that IUD placement as early as 3 weeks postpartum is feasible. Larger studies are needed to evaluate risks and benefits of IUD placement at this early interval. While earlier timing does not result in increased IUD uptake, early placement should be explored as an option since many women resume intercourse before 6 weeks.

An Evaluation of Oral Midazolam for Anxiety and Pain in First-Trimester Surgical Abortion: A Randomized Controlled Trial.

OBJECTIVE: To estimate the effect of oral midazolam on patient pain and anxiety perception during first-trimester surgical abortion. METHODS: Between May and December 2013, we conducted a randomized, double-blind, placebo-controlled trial. Patients between 6 0/7 and 10 6/7 weeks of gestation received 10 mg oral midazolam or placebo 30-60 minutes before surgical abortion. All patients received ibuprofen and a paracervical block. We powered the study (power=80%; significance level=.025) to detect a 15-mm difference in our two a priori primary outcomes of pain and anxiety with uterine aspiration on a 100-mm visual analog scale. Secondary outcomes were pain and anxiety at additional time points, memory, satisfaction, side effects, and adverse events. RESULTS: Demographics were similar between groups (placebo=62, midazolam=62). Compared with those randomized to placebo, patients who received midazolam had significantly less anxiety preoperatively (room entry: 51.4 mm compared with 34.5 mm, P<.001; positioning: 56.6 mm compared with 45.4 mm, P=.02). There was no difference in pain (P=.28) or anxiety (P=.14) during uterine aspiration or at other procedural time points. A significantly greater number of patients in the midazolam group reported partial amnesia (31/61 compared with 16/61, P=.005) and dizziness (30/61 compared with 18/61, P=.03). Controlling for baseline differences, patients who received midazolam reported more postoperative sleepiness (P<.001) and less postoperative nausea (P=.004). There was no difference in overall satisfaction (P=.88). CONCLUSION: Although oral midazolam reduces preprocedural anxiety, it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01830881. LEVEL OF EVIDENCE: I.

Prohibiting consent: what are the costs of denying permanent contraception concurrent with abortion care?

OBJECTIVE: Oregon and federal laws prohibit giving informed consent for permanent contraception when presenting for an abortion. The primary objective of this study was to estimate the number of unintended pregnancies associated with this barrier to obtaining concurrent tubal occlusion and abortion, compared with the current policy, which limits women to obtaining interval tubal occlusion after abortion. The secondary objectives were to compare the financial costs, quality-adjusted life years, and the cost-effectiveness of these policies. STUDY DESIGN: We designed a decision-analytic model examining a theoretical population of women who requested tubal occlusion at time of abortion. Model inputs came from the literature. We examined the primary and secondary outcomes stratified by maternal age (>30 and <30 years). A Markov model incorporated the possibility of multiple pregnancies. Sensitivity analyses were performed on all variables and a Monte Carlo simulation was conducted. RESULTS: For every 1000 women age <30 years in Oregon who did not receive requested tubal occlusion at the time of abortion, over 5 years there would be 1274 additional unintended pregnancies and an additional $4,152,373 in direct medical costs. Allowing women to receive tubal occlusion at time of abortion was the dominant strategy. It resulted in both lower costs and greater quality-adjusted life years compared to allowing only interval tubal occlusion after abortion. CONCLUSION: Prohibiting tubal occlusion at time of abortion resulted in an increased incidence of unintended pregnancy and increased public costs.

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

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.

Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459. LEVEL OF EVIDENCE: I.

Adolescent experience with intrauterine device insertion and use: a retrospective cohort 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.

Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094366. LEVEL OF EVIDENCE: I.

Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial.

BACKGROUND: The study was conducted to examine the effects of a 4% intrauterine lidocaine infusion on patient-perceived pain during transcervical sterilization. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION: Intrauterine lidocaine prior to outpatient transcervical sterilization does not decrease pain.

Sex education and contraceptive use at coital debut in the United States: results from Cycle 6 of the National Survey of Family Growth.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials.

BACKGROUND: First-trimester abortions especially cervical dilation and suction aspiration are associated with pain despite various methods of pain control. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Pain control in first trimester surgical abortion.

BACKGROUND: First trimester abortions especially cervical dilation and suction aspiration are associated with pain, despite various methods of pain control. OBJECTIVES: Compare different methods of pain control during first trimester surgical abortion. SEARCH STRATEGY: We searched multiple electronic databases with the appropriate key words, as well as reference lists of articles, and contacted professionals to seek other trials. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data. Meta-analysis results are expressed as weighted mean difference (WMD) or Peto Odds ratio with 95% confidence interval (CI). MAIN RESULTS: We included forty studies with 5131 participants. Due to heterogeneity we divided studies into 7 groups:Local anesthesia: Data was insufficient to show a clear benefit of a paracervical block (PCB) compared to no PCB or a PCB with bacteriostatic saline. Pain scores during dilation and aspiration were improved with 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 with dilation and aspiration respectively).PCB with premedication: Ibuprofen and naproxen resulted in small reduction of intra- and post-operative pain.Analgesia: Diclofenac-sodium did not reduce pain.Conscious sedation: The addition of conscious intravenous sedation using diazepam and fentanyl to PCB decreased procedural pain.General anesthesia (GA): Conscious sedation increased intraoperative but decreased postoperative pain compared to GA (Peto OR 14.77 95% CI 4.91 to 44.38, and Peto OR 7.47 95% CI 2.2 to 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 COX 2 inhibitor etoricoxib, the non-selective COX inhibitors lornoxicam, diclofenac and ketorolac IM, and the opioid nalbuphine were improved postoperative pain.Non-pharmacological intervention: Listening to music decreased procedural pain.No major complication was observed. AUTHORS' CONCLUSIONS: Conscious sedation, GA and some non-pharmacological interventions decreased procedural and postoperative pain, while being safe and satisfactory to patients. Data on the widely used PCB is inadequate to support its use, and it needs to be further studied to determine any benefit.

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$1409.50) and those who did not (US$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.

Body mass index and sexual behavior.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: With the exception of ever engaging in sexual intercourse with a man, sexual behavior differs little between women of different body mass indices.

Predictors and perception of pain in women undergoing first trimester surgical abortion.

BACKGROUND: 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. STUDY DESIGN: 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. RESULTS: 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). CONCLUSION: 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.