Rameet H. Singh

Effect of Progestin Compared With Combined Oral Contraceptive Pills on Lactation: A Randomized Controlled Trial.

OBJECTIVE: To estimate the effect of progestin-only compared with combined hormonal contraceptive pills on rates of breastfeeding continuation in postpartum women. Secondary outcomes include infant growth parameters, contraceptive method continuation, and patient satisfaction with breastfeeding and contraceptive method. METHODS: Postpartum breastfeeding women who desired oral contraceptives were randomly assigned to progestin-only and combined hormonal contraceptive pills. At 2 and 8 weeks postpartum, participants completed in-person questionnaires that assessed breastfeeding continuation and contraceptive use. Infant growth parameters including weight, length, and head circumference were assessed at 8 weeks postpartum. Telephone questionnaires assessing breastfeeding, contraceptive continuation, and satisfaction were completed at 3–7 weeks and 4 and 6 months. Breastfeeding continuation was compared between groups using Cox proportional hazards regression. Differences in baseline demographic characteristics and in variables between the two intervention groups were compared using &khgr;2 tests, Fisher exact test, or two-sample t tests as appropriate. RESULTS: Breastfeeding continuation rates at 8 weeks (progestin-only 63.5%; combined hormonal 64.1%), contraceptive continuation, and infant growth parameters did not differ between users of progestin-only and combined hormonal contraceptive pills. Infant formula supplementation and maternal perception of inadequate milk supply were associated with decreased rates of breastfeeding in both groups. CONCLUSION: Choice of combined hormonal or progestin-only contraceptive pills administered 2 weeks postpartum did not adversely affect breastfeeding continuation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01465022. LEVEL OF EVIDENCE: I

Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial

OBJECTIVE To examine the effects of preprocedure misoprostol on intrauterine device (IUD) placement in nulliparous women. STUDY DESIGN In this randomized controlled double-blind trial at the University of New Mexico reproductive health clinic, nulliparous women requesting an IUD were randomized to 400 mcg of buccal misoprostol or placebo 2-8 hours before insertion. Primary outcomes included pain on a 10-cm visual analog scale and womens perception of the value of delaying insertion for an effective medication. Provider ease of insertion and need for adjunctive insertion measures were also assessed, on a visual analog scale. Participants indicated maximum pain after IUD insertion, pain level they would tolerate to avoid delay in IUD insertion, and preference for IUD insertion without delay if an effective medication was available. RESULTS Of 85 women enrolled, 3 were ineligible; 42 were randomized to misoprostol and 40 to placebo. There were no differences between groups in worst insertion pain, (5.8 ± 2.0 vs 5.9 ± 2.0, P = .94), provider ease of insertion (2.2 ± 2.2 vs 2.5 ± 2.2; P = .54) or adjunctive measures (14% vs 25%; P = .27). The groups were willing to tolerate the same mean pain (4.9 ± 2.5 vs 5.7 ± 2.4, P = .18) to avoid waiting for medication. The majority of women (85%) preferred to wait for an effective medication. CONCLUSION Misoprostol for nulliparous women did not decrease pain or improve the ease of insertion of an IUD. Most women were willing to wait for a medication that decreases pain, indicating a need to pursue alternatives for pain control with IUD insertion.

The role of physical examination in diagnosing common causes of vaginitis: a prospective study

Objective We evaluated agreement in diagnoses for bacterial vaginosis (BV), Trichomonas vaginalis (TV) and vulvovaginal candidiasis (VVC) between clinicians examining the patient and performing diagnostic tests versus a clinician with access only to the patients history and diagnostic findings from self-obtained vaginal swabs (SOVS). Design Women presenting with vaginal discharge to a sexually transmitted infections clinic provided SOVS for evaluation and completed the study and qualitative questionnaires. A clinician then obtained a history and performed speculum and bimanual examinations. Participants’ history and diagnostic test results from SOVS were provided to a masked non-examining clinician who rendered independent diagnoses. Overall agreement in diagnoses and κ statistics was calculated. Results The prevalence of infections among the 197 participants was 63.4% (BV), 19% (TV) and 14% (VVC). The per cent agreement between the examining and non-examining clinician for the diagnoses of BV was 68.5%, 90.9% for TV and 91.9% for VVC. Of the 105 women diagnosed with BV by the examining clinician, 34 (32%) were missed by the non-examining clinician. The non-examining clinician missed 13 (48%) of 27 women and 12 (34%) of 35 women treated for VVC and TV, respectively. Four women who all presented with abdominal pain were diagnosed with pelvic inflammatory disease. Conclusions Tests from SOVS and history alone cannot be used to adequately diagnose BV, TV and VVC in women presenting with symptomatic vaginal discharge. Cost benefits from eliminating the speculum examination and using only tests from SOVS may be negated by long-term costs of mistreatment.

Postpartum contraceptive choices among ethnically diverse women in New Mexico.

OBJECTIVE The objective of the study was to determine if postpartum contraceptive choices by primiparous women differ by ethnicity. STUDY DESIGN Retrospective nested cohort study analyzing womens characteristics and contraceptive choice. RESULTS Of 652 participants, 312 (47.8%) were Hispanic, 287 (44.0%) were non-Hispanic white, and 53 (8.1%) were American Indian (AI). In multivariate analysis, depot medroxyprogesterone acetate (DMPA) and intrauterine device (IUD)/implant choice was related to AI [DMPA: odds ratio (OR) 15.28, confidence interval (CI) 4.49-52.04; IUD/implant: OR 0.46, CI 0.22-0.92] and Hispanic (DMPA: OR 3.44, CI 1.12-10.58) ethnicity. CONCLUSION DMPA use was higher among Hispanic and AI women and IUD/implant use lower in AI women compared to non-Hispanic white women.

Nitrous oxide for pain management of first trimester surgical abortion -- a randomized controlled pilot study.

OBJECTIVE The objective was to determine feasibility of a study comparing mean pain scores between women randomized to nitrous oxide/oxygen (NO) versus oxygen+oral analgesics for trimester surgical abortion. STUDY DESIGN Pilot randomized controlled trial comparing NO (n=10) versus oxygen+oral analgesics (n=10). Feasibility of subject recruitment, and pain and satisfaction scores on a visual analog scale were evaluated. RESULTS Fifty-seven percent of eligible women participated. Mean pain scores were similar between groups, and mean satisfaction scores were higher for the NO group (77.5 vs. 46.7, P=.048). CONCLUSIONS The majority of eligible women agreed to participate in this study evaluating an uncommon pain control intervention.

Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial

Background Immediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast‐feeding outcomes. Objective This study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast‐feeding outcomes. Study Design We conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast‐feed, spoke English or Spanish, were aged 18‐40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4‐12 weeks’ postpartum. Prespecified exclusion criteria included delivery <37.0 weeks’ gestational age, chorioamnionitis, postpartum hemorrhage, contraindications to levonorgestrel intrauterine device insertion, and medical complications of pregnancy that could affect breast‐feeding. We conducted per‐protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent‐to‐treat analysis. We powered the study for the primary outcome, breast‐feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention. Results We met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast‐feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70–86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76–91%). The 5% difference in breast‐feeding continuation at 8 weeks between the groups fell within the noninferiority margin (95% confidence interval, –5.6 to 15%). Time to lactogenesis (mean ± SD) in the immediate group, 65.3 ± 25.7 hours, was noninferior to that of the delayed group, 63.6 ± 21.6 hours. The mean difference between groups was 1.7 hours (95% confidence interval, –4.8 to 8.2 hours), noninferior by log‐rank test. A total of 24 intrauterine device expulsions occurred in the immediate group compared to 2 in the delayed group (19% vs 2%, P < .001), consistent with the known higher expulsion rate with immediate vs delayed postpartum intrauterine device insertion. No intrauterine device perforations occurred in either group. Conclusion Our results of noninferior breast‐feeding outcomes between women with immediate and delayed postpartum levonorgestrel intrauterine device insertion suggest that immediate postpartum intrauterine device insertion is an acceptable option for women planning to breast‐feed and use the levonorgestrel intrauterine device. Expulsion rates are higher with immediate postpartum levonorgestrel intrauterine device insertion compared to delayed insertion, but this disadvantage may be outweighed by the advantages of immediate initiation of contraception. Providers should offer immediate postpartum intrauterine device insertion to breast‐feeding women planning to use the levonorgestrel intrauterine device.

A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women

To evaluate the effectiveness of inhaled nitrous oxide for pain management among nulliparous women undergoing intrauterine device (IUD) insertion.

Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial

OBJECTIVES To evaluate whether inhaled nitrous oxide with oxygen (N2O/O2) is associated with less pain compared to oral sedation for pain management during in-office hysteroscopic sterilization. STUDY DESIGN This double blinded randomized controlled trial enrolled women undergoing in-office hysteroscopic sterilization. All participants received pre-procedure intramuscular ketorolac and a standardized paracervical block. The intervention group also received N2O/O2 via a nasal mask titrated to a maximum 70%:30% mixture by a nurse during the procedure and placebo pills pre-procedure and the active control group received inhaled O2 during the procedure and 5/325 mg hydrocodone/acetaminophen and 1 mg lorazepam pre-procedure. The primary outcome was maximum procedure pain on a 100 mm Visual Analog Scale (VAS with anchors at 0=no pain and 100=worst imaginable pain) assessed 3-5 min post procedure. Thirty women per treatment arm were required to detect a clinically significant pain difference of 20 mm. RESULTS Seventy-two women, 36 per study arm, were randomized. Mean age of participants was 34.1±5.7 years and mean BMI was 30.1±6.6kg/m2. Mean maximum procedure pain scores were 22.8±27.6 mm and 54.5±32.7 mm for intervention and control groups, respectively (p<.001). Most study participants (97%) stated N2O/O2 should be offered for gynecologic office procedures and 86% would pay for it if not a covered benefit. CONCLUSIONS N2O/O2 decreased pain with in-office hysteroscopic sterilization compared to oral sedation and is an effective pain management option for this procedure. IMPLICATIONS Given its safety and favorable side effect profile, N2O/O2 can be used for pain management for in-office hysteroscopic sterilization and adds a safe, easily administered option to currently available strategies.

Society of Family Planning Clinical Guidelines Pain control in surgical abortion Part 1-Local anesthesia and minimal sedation

Satisfactory pain control for women undergoing surgical abortion is important for patient comfort and satisfaction. Clinicians ought to be aware of the safety and efficacy of different pain control regimens. This document will focus on nonpharmacologic modalities to reduce pain and pharmacologic interventions up to the level of minimal sedation. For surgical abortion without intravenous medications, a multimodal approach to pain control may combine a dedicated emotional-support person, visual or auditory distraction, administration of local anesthesia to the cervix with buffered lidocaine and a preoperative nonsteroidal anti-inflammatory drug. Oral opioids do not decrease procedural pain. Oral anxiolytics decrease anxiety but not the experience of pain. Further research is needed on alternative options to control pain short of moderate or deep sedation.

Nitrous Oxide for Pain Management During In-Office Hysteroscopic Sterilization: A Randomized Controlled Trial [21O]

INTRODUCTION: To evaluate whether inhaled nitrous oxide with oxygen (N2O/O2) is superior to oral sedation for pain management during in-office hysteroscopic sterilization. METHODS: This double blinded randomized controlled trial enrolled women undergoing in-office hysteroscopic sterilization. The intervention group received N2O/O2 titrated to a maximum 70%:30% mixture and placebo pills pre procedure. The control group received inhaled O2 during the procedure and 5/325 mg hydrocodone/acetaminophen and 1 mg lorazepam pre procedure. The primary outcome was maximum procedural pain on a 100 mm Visual Analogue Scale (VAS) assessed 3–5 minutes post procedure. A sample size of 30 women per treatment arm was required to detect a clinically significant pain difference of 20 mm on the VAS. RESULTS: 72 women, 36 per study arm, were randomized to account for unsuccessful bilateral coil placement and drop out after randomization. Two women in the study group and 6 in the control group were excluded due to unsuccessful bilateral coil placement. Mean age of participants was 34.1±5.7 years and mean BMI was 30.1±6.6 kg/m2. Mean maximum procedural pain scores were 22.8±27.6 mm and 54.5±32.7 mm for study and control groups, respectively (P<.001). Most study participants (97%) stated NOS should be offered for gynecologic office procedures and 86% would pay for NOS if it were not a covered benefit. CONCLUSION: NOS decreased pain with in-office hysteroscopic sterilization compared to oral sedation. Given its safety and favorable side effect profile, NOS should be considered for routine availability for in-office hysteroscopic sterilization.