Elizabeth Micks

The effect of nitroprusside on 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.

Blockade of tubal patency following transcervical administration of polidocanol foam: initial studies in rhesus macaques ☆ ☆☆

OBJECTIVE To demonstrate the feasibility of polidocanol foam (PF) as a nonsurgical method of female permanent contraception using a nonhuman primate model. STUDY DESIGN Four groups of adult female rhesus macaques underwent either transcervical treatment with 5% PF directly into the uterine cavity, treatment with inert (methylcellulose, MF) foam or no treatment followed by removal of the reproductive tract for histologic evaluation. Untreated animals were included in Group 1 (n=3). Group 2 animals (n=4) were treated once with MF. Group 3 (n=7) received a single, and Group 4 (n=5) received multiple monthly treatments with PF; in these 2 groups, baseline tubal patency was assessed either laparoscopically by chromopertubation (CP) or by hysterosalpingography. RESULTS Group 1 (untreated) and Group 2 (MF) animals had normal tubal histology. In contrast, Group 3 and 4 females treated with PF showed evidence of tubal damage. In Group 4, bilateral tubal blockade was noted on CP after two (n=2) or three (n=3) treatments. Histologic analysis confirmed complete tubal occlusion (loss of epithelium, fibrosis) in three of these animals, and one showed significant tubal damage localized to the intramural segment. Nontarget (cervix, vagina, endometrium, ovary) reproductive tissues were unaffected. While similar tubal changes were observed after a single treatment (Group 3), endometrial hemorrhage was also noted as an acute change. CONCLUSION PF is a promising candidate agent for nonsurgical permanent female contraception. The histologic features of PF occlusion are confined to the intramural portion of the tube. IMPLICATIONS This study in rhesus macaques supports further development of transcervical administration of PF as a nonsurgical approach to permanent contraception. A nonsurgical method could reduce risks and costs associated with surgical female sterilization and increase access to permanent contraception.

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.

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

OBJECTIVE Concern about pain during placement of an intrauterine device (IUD) represents a barrier to use, especially among nulliparous women. We hypothesized that nitroglycerin gel applied vaginally 30 min prior to IUD placement would reduce insertion-related pain. STUDY DESIGN We designed a randomized, double-blinded, placebo-controlled pilot study to evaluate the efficacy and tolerability of 0.5-mg nitroglycerin gel (1 mL) or identical placebo gel applied vaginally in nulliparous women 30 min prior to IUD placement. The study was limited to women who opted for the levonorgestrel-releasing intrauterine system. Subjects completed a series of 100-mm visual analogue scales at several time points. The primary outcome was subject-reported pain with passage of the IUD through the cervix. Secondary outcomes included subject-reported pain at other time points, provider-reported ease of insertion, 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 55.0 mm [standard deviation (SD) = 29.7 mm] in the placebo group and 57.4 mm (SD 22.1 mm) in the nitroglycerin group (p=.82). There was no difference in ease of insertion reported by providers. Two subjects required dilation, one in each group. CONCLUSION Vaginal administration of 0.5-mg nitroglycerin gel 30 min prior to IUD placement does not appear to decrease patient-reported procedural pain among nulliparous women or ease of insertion for providers.

Pain relief for obstetric and gynecologic ambulatory procedures.

As minor gynecologic procedures move from the operating room to the office, providers need to ensure that patients are comfortable and that procedures are performed safely. Although local anesthesia is commonly used for gynecologic procedures, a multimodal approach may be more effective. If necessary, sedation can be safely provided in an office setting with the correct tools and training. This article reviews evidence-based approaches to pain management for gynecologic procedures in the ambulatory setting.

Treatment of Heavy Menstrual Bleeding with the Estradiol Valerate and Dienogest Oral Contraceptive Pill

The new estradiol valerate and dienogest oral contraceptive pill recently received U.S. Food and Drug Administration (FDA) approval to treat heavy menstrual bleeding in women without diagnosed uterine conditions.This oral contraceptive formulation combines estradiol valerate, which is metabolically identical to natural estradiol, with the potent new progestin, dienogest. The four-phasic pill is effective for pregnancy prevention and leads to significantly decreased menstrual bleeding among women with heavy periods, and shorter and lighter periods among women with normal periods. Studies indicate that this formulation may be associated with decreased hepatic activation compared to contraceptive pills that contain ethinyl estradiol. However, whether these findings translate to a decreased risk of thrombotic events has not been determined, and the pill carries the same contraindications as all other combined hormonal contraceptives.At least 10–15% of women suffer from heavy menstrual bleeding, defined as ≥80 mL of blood loss per cycle. In large clinical trials of women with heavy menstrual bleeding, the estradiol valerate and dienogest pill decreased blood loss volume by a median of 81%.Women with heavy menstrual bleeding treated with this contraceptive pill can expect a significant reduction in bleeding after just one cycle of use. This therapy leads to a decrease in bleeding that may be greater than that achieved by different oral contraceptive pills or other medical therapies, including tranexamic acid and nonsteroidal anti-inflammatory drugs.

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 (&agr;=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

Heterosexual Anal Intercourse in the United States [6].

INTRODUCTION: More than one-third of women in the U.S. have engaged in heterosexual anal intercourse (HAI). The risk of acquiring HIV per sexual act is estimated to be 18 times higher for receptive anal intercourse than receptive vaginal intercourse; HAI is also associated with lower rates of condom use. We sought to describe frequency of HAI and condom use, HAI motivations, and HIV knowledge in the U.S. METHODS: A nationally representative sexual behavior survey of 5,162 women and men aged 18–50 year old was conducted. Data were analyzed using chi-square tests, t tests, and multivariable log-binomial regression. RESULTS: Thirty-seven percent of women have engaged in HAI. In the past three months, 12.2% have engaged in HAI, compared to 83.0% reporting vaginal intercourse. The most common motivations for HAI were self and partner pleasure and curiosity. Twice as many men as women reported ever using HAI as a method of contraception (13.5% vs 6.6%, P<.001). Condom use was lower for anal versus vaginal intercourse (9% vs 16%, P<.001). More than 70% of adults erroneously believe that HIV transmission risk is greater for vaginal intercourse than anal intercourse. CONCLUSION/IMPLICATIONS: HAI is common in the U.S. Both women and men report a wide range of motivations for both HAI and condom use with HAI. Significant knowledge gaps exist regarding HAI and HIV transmission.

Why Stop Now? Extended and Continuous Regimens of Combined Hormonal Contraceptive Methods.

Combined hormonal contraceptives (CHCs) have traditionally been prescribed in 28-day cycles, with 21 days of active hormones followed by a 7-day hormone-free interval. Extended and continuous CHC regimens, defined as regimens with greater than 28 days of active hormones, offer many benefits, including a decrease in estrogen-withdrawal symptoms and likely greater efficacy because of more reliable ovulation suppression. Bleeding profiles are favorable, and unscheduled bleeding decreases over time with these regimens. Extended and continuous regimens of combined oral contraceptives and the contraceptive vaginal ring are safe and have high user acceptability and satisfaction. However, despite numerous benefits, extended and continuous CHC regimens are underused.

Medical termination of pregnancy in cynomolgus macaques

Although pregnancy is expected during studies of novel contraceptives in non‐human primates, gestation, delivery, and lactation remove females from groups for prolonged intervals. As the macaque cervix does not facilitate transcervical surgical termination of pregnancy, we sought to establish a medical termination protocol.