Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial.

BACKGROUND: Fear of pain during the insertion of intrauterine contraceptives is a barrier to using these methods, especially for nulligravidas. An intracervical block may be easier and more reproducible than a paracervical block; however, this intervention has not been evaluated in nulligravid women to reduce pain with intrauterine contraceptive insertion. OBJECTIVE: To evaluate whether a 3.6-mL 2% lidocaine intracervical block reduces pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas; and, in addition, to assess whether the intracervical block has any effect on the ease of device insertion and on the overall experience with the procedure. MATERIALS AND METHODS: In this randomized double-blind controlled trial, nulligravidas were block-randomized to 1 of 3 arms prior to 52-mg levonorgestrel-releasing intrauterine system insertion: 3.6-mL 2%-lidocaine intracervical block, sham injection (intracervical dry-needling), or no intervention. The primary outcome was pain at levonorgestrel-releasing intrauterine system insertion. Secondary outcomes were pain at tenaculum placement, ease of insertion (assessed by healthcare providers), and the overall experience with the procedure (pain with levonorgestrel-releasing intrauterine system insertion compared with expectations, discomfort level, wish to undergo another device insertion in the future, and recommendation of the procedure to others). Participants' pain was measured with a 10-cm visual analogue scale and a 5-point Faces Pain Scale. Pain was summarized into categories (none, mild, moderate, severe) and also analyzed as a continuous variable (mean and 95% confidence interval). Our sample size had 80% power (α = 0.05) to detect a 15% difference in pain score measured by visual analogue scale (mean [standard deviation] visual analogue scale score = 5.9 [2.0] cm) and an absolute difference of 20% in the proportion of women reporting severe pain at levonorgestrel-releasing intrauterine system insertion among groups. We used a χ2 test and a mixed-effects linear regression model. We calculated the number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion. RESULTS: A total of 302 women were randomized (99 to the intracervical block, 101 to the intracervical sham, and 102 to no intervention), and 300 had a successful device insertion. The intracervical block group had fewer women reporting severe pain than the other groups, both at tenaculum placement (intracervical block: 2% vs sham: 30.2% vs no intervention: 15.2%, P < .0001) and at levonorgestrel-releasing intrauterine system insertion (intracervical block: 26.5% vs sham: 59.4% vs no intervention: 50.5%, P < .0001). The mean (95% confidence interval) pain score reported at levonorgestrel-releasing intrauterine system insertion was lower in the intracervical block group than in the other groups (intracervical block: 4.3 [3.8-4.9] vs sham: 6.6 [6.2-7.0], P < .0001; intracervical block: 4.3 [3.8-4.9] vs no intervention: 5.8 [5.3-6.4], P < .0001). Women from the intracervical block group reported less pain than expected (P < .0001), rated the insertion as less uncomfortable (P < .0001), and were more willing to undergo another device insertion in the future (P < .01) than women in the other groups. The ease of insertion were similar among groups. The number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion was 2 and 4, respectively. CONCLUSION: A 3.6-mL 2% lidocaine intracervical block decreased pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas. It also provided a better overall experience during the procedure.

Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review.

A 2013 review found no evidence to support the routine use of pain relief for intrauterine contraceptive (IUC) placement; however, fear of pain with placement continues to be a barrier to use for some women. This narrative review set out to identify (1) new evidence that may support routine use of pain management strategies for IUC placement; (2) procedure-related approaches that may have a positive impact on the pain experience; and (3) factors that may help healthcare professionals identify women at increased risk of pain with IUC placement. A literature search of the PubMed and Cochrane library databases revealed 550 citations, from which we identified 43 new and pertinent studies for review. Thirteen randomized clinical trials, published since 2012, described reductions in placement-related pain with administration of oral and local analgesia (oral ketorolac, local analgesia with different lidocaine formulations) and cervical priming when compared with placebo or controls. Four studies suggested that ultrasound guidance, balloon dilation, and a modified placement device may help to minimize the pain experienced with IUC placement. Eight publications suggested that previous cesarean delivery, timing of insertion relative to menstruation, dysmenorrhea, expected pain, baseline anxiety, and size of insertion tube may affect the pain experienced with IUC placement. Oral and local analgesia and cervical priming can be effective in minimizing IUC placement-related pain when compared with placebo, but routine use remains subject for debate. Predictive factors may help healthcare professionals to identify women at risk of experiencing pain. Targeted use of effective strategies in these women may be a useful approach while research continues in this area.

A single post-ovulatory dose of ulipristal acetate impairs post-fertilization events in mice.

Ulipristal acetate (UPA) is a selective progesterone receptor modulator used for emergency contraception that has proven to be highly effective in preventing pregnancy when taken up to 120 h after unprotected sexual intercourse. Even though it may act mainly by delaying or inhibiting ovulation, additional effects of UPA on post-fertilization events cannot be excluded. Therefore, the aim of this study was to determine whether a single post-ovulatory dose of UPA could prevent pregnancy using the mouse as a pre-clinical model. Mated females received a single dose of UPA (40 mg/kg) on Day E1.5 or E2.5 (E0.5: copulatory plug detection) and post-fertilization events were evaluated. Our studies revealed that UPA administration produced a significant decrease in the number of conceptuses compared to control. Moreover, UPA-treated females exhibited a lower number of early implantation sites on Day E5.5, despite normal in vivo embryo development and transport to the uterus at E3.5. Administration of UPA produced histological and functional alterations in the uterine horns, i.e., a dyssynchronous growth between endometrial glands and stroma, with non-physiological combination of both fractions compared to controls, and a completely impaired ability to respond to an artificial decidualization stimulus. Altogether, our results show that the administration of a single post-ovulatory dose of UPA impairs mouse pregnancy probably due to an effect on embryo-uterine interaction, supporting additional effects of the drug on post-fertilization events. Although these studies cannot be performed with human samples, our results with the mouse model provide new insights into the mechanism of action of UPA as an emergency contraception method.

The Practice of Hatha Yoga for the Treatment of Pain Associated with Endometriosis.

OBJECTIVES: The aim of this study was to compare chronic pelvic pain, menstrual patterns, and quality of life (QoL) in two groups of women with endometriosis: those who did and those who did not participate in a specific 8-week yoga intervention. METHOD: This was a randomized controlled trial. It was conducted at the University of Campinas Medical School, Campinas, SP, Brazil. Forty women were randomly divided into two groups: an intervention group of women who practiced yoga (n = 28), and a control group of women who did not practice yoga (n = 12). Participants attended 90-min scheduled yoga sessions twice a week for 8 weeks. Additionally, an Endometriosis Health Profile (EHP)-30 questionnaire was applied to evaluate women's QoL at admission and 2 months later upon completion of the yoga program. Menstrual and daily pain patterns were evaluated through a daily calendar (visual analog scale). RESULTS: The degree of daily pain was significantly lower among the women who practiced yoga compared with the non-yoga group (p = 0.0007). There was an improvement of QoL in both groups between baseline and the end of the study evaluation. In relation to EHP-30 domains, pain (p = 0.0046), impotence (p = 0.0006), well-being (p = 0.0009), and image (p = 0.0087) from the central questionnaire, and work (p = 0.0027) and treatment (p = 0.0245) from the modular questionnaire were significantly different between the study groups over time. There was no significant difference between the two groups regarding the diary of menstrual patterns (p = 0.96). CONCLUSIONS: Yoga practice was associated with a reduction in levels of chronic pelvic pain and an improvement in QoL in women with endometriosis.

A Qualitative Study on the Practice of Yoga for Women with Pain-Associated Endometriosis.

OBJECTIVES: To understand the meaning women with pain-associated endometriosis attribute to yoga practice regarding their physical and emotional state at the beginning of the practice; pain management by integrating body and mind; secondary benefits of the practice of yoga, such as self-knowledge, self-care, and autonomy; and the role of the yoga group as psychosocial support. DESIGN: Qualitative study conducted simultaneously with a randomized clinical trial. SETTING: Public university hospital in southeastern Brazil between August 2013 and December 2014. PARTICIPANTS: Fifteen women with pain-associated endometriosis who practiced yoga for 8 weeks. INTERVENTION: After completing the twice-a-week program, all women participated in a single, semi-structured interview. Interviews were recorded and transcribed verbatim, and thematic analyses were performed. OUTCOME MEASURES: The main themes of analysis were women's expectations regarding the practice of yoga, physical and emotional state of women at the beginning of yoga practice, control and pain management through the integration of body and mind, secondary benefits, acquisition of self-knowledge and autonomy, and the role of yoga group as psychosocial support. RESULTS: All participants reported that yoga was beneficial to control pelvic pain. They related that they were aware of the integration of body and psyche during yoga practice and that this helped in the management of pain. Women said they had identified a relationship between pain management and breathing techniques (pranayama) learned in yoga and that breathing increased their ability to be introspective, which relieved pain. The participants have developed greater self-knowledge, autonomy, and self-care and have reduced the use of pain and psychiatric medications. They created ties among themselves, suggesting that the yoga group allowed psychosocial support. CONCLUSIONS: Bodily and psychosocial mechanisms to control pain were identified in women with endometriosis. To reach such control, it is crucial that mind and body integrative techniques are learned.

Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth.

OBJECTIVE: To measure infants' breast milk intake and infant growth when their mothers initiated either combined oral contraceptive (COC), levonorgestrel-releasing intrauterine system, or etonogestrel-releasing implant, or copper intrauterine device (IUD) as a reference group. DESIGN: Prospective trial. SETTING: University-based hospital. PATIENT(S): On postpartum day 42, 40 women initiated a contraceptive method according to their choice. INTERVENTION(S): Deuterium (D2O; 0.5 g/kg mother's weight) was ingested by mothers on postpartum days 42, 52, and 63 as a marker of total body fluid. MAIN OUTCOME MEASURE(S): Infants' milk intake from 42 to 63 postpartum days was assessed by measurement of D2O levels in infants' saliva and infant growth by measuring their body weight, height, and tibia length. Women recorded all infant feed and changes of diapers wet with urine. Breastfeeding continuation was assessed at 6 months postpartum. RESULT(S): Infant mean milk intake, mean growth increase, mean number of breastfeeding episodes, daily wet diaper changes, and mean duration of exclusively breastfeeding (~5 months) were similar in the four groups. CONCLUSION(S): Use of a COC, the two progestin-only contraceptives, or copper IUD did not affect the amount of infant milk intake and growth up to 9 weeks of age. The incidence of full breastfeeding and breastfeeding continuation was similar with contraceptive hormonal use and no use. CLINICAL TRIALS REGISTRATION NUMBER: NCT01388582.

Use of contraceptive methods and contraceptive recommendations among health care providers actively involved in contraceptive counseling -- results of an international survey in 10 countries.

BACKGROUND: This study was conducted to determine the personal choices of contraceptive methods among an international sample of contraception health care professionals (HCPs) and to determine if these choices are concordant with their recommendations to women. STUDY DESIGN: In an anonymous online survey, 1001 HCPs actively involved in contraceptive counseling [obstetrician/gynecologists (OB/GYNs), general practitioners (GPs) and midwives (only in Sweden)] from 10 countries (Australia, Brazil, Canada, France, Germany, Korea, Mexico, Spain, Sweden and the United Kingdom) were asked about their personal use of contraceptive methods and their recommendations to women in two different clinical scenarios: for spacing between children (Group A) and after completion of the family (Group B). RESULTS: The largest HCP group was OB/GYNs (67.1%), followed by GPs (31.4%) and midwives (1.5%). A total of 42.7% of respondents were male, and 57.3% were female. The majority of respondents were aged 36-45 years (38.9%) or 46-55 years (42.8%), 79.7% had children, and 53.9% were currently using contraception (by themselves or by their partners). Among 540 contraceptive users, the three most common methods were the levonorgestrel-releasing intrauterine system (LNG-IUS; 29.3%), combined oral contraceptives (COCs; 20.0%) and condoms (17.0%). OB/GYNs were more likely to be using the LNG-IUS than GPs (p=.014). Gender did not seem to influence contraceptive preference. Reasons for these choices were largely influenced by family situation and high contraceptive efficacy (for the LNG-IUS) or side effects caused by other methods (for condoms). The top contraceptive recommendation was COCs for Group A and the LNG-IUS for Group B. HCPs currently using COCs and the LNG-IUS were more likely to recommend these methods than other contraceptive methods for Group A and Group B, respectively. CONCLUSIONS: The most popular contraceptive method in this sample of HCPs was the LNG-IUS. Choice of contraceptive method was driven by family situation, age and profession. It appears that, in this sample, personal contraceptive use influences contraceptive recommendations.

Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial.

OBJECTIVE: To assess the efficacy of intravaginal electrical stimulation (IVES) or placebo in women with chronic pelvic pain (CPP) with no apparent cause. STUDY DESIGN: A double-blind, crossover, randomized clinical trial in which 26 women were randomly allocated to active (group I, n = 15) or placebo (group II, n = 11) IVES. All women underwent 10 30-minute, twice-weekly sessions. The groups were then crossed over for a further 10 sessions. Pain was evaluated using a visual analog scale (VAS) before and after each series. RESULTS: At the end of the first series, 5 of 11 women who initiated with the placebo had a VAS pain score > 3 (p = 0.0253); however, when they crossed over to active IVES, only 1 had a VAS pain score > 3 at the end of the series (p = 0.0143). In the 15 women who initiated with active IVES, 2 had a score > 3 at the end of the series (p = 0.0005); however, when they crossed over to the placebo, 3 had a VAS pain score > 3 at the end of treatment (p = 0.0833). After the 2 sessions, 54.6% who initiated with placebo and 80% who initiated with active IVES had a VAS pain score < 3. CONCLUSION: Intravaginal electrical stimulation was more effective than a placebo in alleviating pain in women with CPP.

Intravaginal electrical stimulation for the treatment of chronic pelvic pain.

OBJECTIVE: To evaluate the efficacy of intravaginal electrical stimulation in women with chronic pelvic pain (CPP). STUDY DESIGN: Between May 2002 and February 2004, 24 women with CPP with no apparent cause were evaluated. They underwent 10 sessions of intravaginal electrical stimulation. A program for measuring chronic diffuse pain, with a frequency of 8 Hz, variation in intensity and frequency, pulse length of 1 msec, and adjustment to the bearable intensity of each individual patient (in milliamps) was utilized. Treatment consisted of 30-minute applications, 2 or 3 times per week, and the pain was evaluated using a visual analog scale before and after each session and immediately after completion of the total treatment. The women were asked to evaluate the pain 2 weeks, 4 weeks and 7 months following the end of treatment. RESULTS: Intravaginal electrical stimulation was effective in alleviating pain in women with CPP, as evaluated at the end of treatment and 2 weeks, 4 weeks and 7 months after completion of treatment (p<0.05). There were significantly fewer complaints of dyspareunia following treatment (p = 0.0005). CONCLUSION: Intravaginal electrical stimulation is effective in the alleviation of pain in women with CPP.