Treatment of Prepubertal Labial Adhesions: A Randomized Controlled Trial

Study ObjectiveAlthough various treatment options have been proposed for the treatment of labial adhesions, there are currently no clearly outlined limits on the duration of topical therapy, amount of lateral traction to apply, and methods to decrease the recurrence. This clinical trial was undertaken to assess the need for estrogen for treatment of prepubertal labial adhesions.DesignRandomized, double-blinded, controlled trial.SettingPediatric and Adolescent Gynecology Clinic at a children's hospital in a metropolitan area.ParticipantsPrepubertal girls ages 3 months to 12 years with labial adhesions.InterventionsLateral traction with topical estrogen or topical emollient.Main Outcome MeasuresThe primary outcome was resolution of labial adhesions. The secondary outcome was the change in severity of labial adhesions over time between the 2 groups.ResultsForty-three girls were enrolled and 38 (88%) completed the study. The difference in complete resolution between the topical emollient group (19%) and the topical estrogen group (36%) was not statistically significant (P = .21). There was a statistically significant decrease in severity of labial adhesions over time, with the magnitude of improvement favoring the topical estrogen group.ConclusionAlthough labial adhesion severity decreased when treated with lateral traction and topical emollient or topical estrogen, the magnitude of the effect was significantly greater for topical estrogen.     

Optimal Dose of Pituitrin in Laparoscopic Uterine Myomectomy: A Double-Blinded,Randomized Controlled Trial

Study ObjectiveTo determine the optimal effective dose of pituitrin in laparoscopic myomectomy for uterine leiomyoma.DesignDouble-blinded, randomized controlled trial.SettingTertiary women's hospital in China.PatientsTotal of 118 patients who underwent laparoscopic myomectomy.InterventionsPatients randomly received 0, 2, 4, or 6 units of pituitrin injected into the myometrium surrounding the myoma.Measurements and Main ResultsRate of satisfactory surgical condition, hemodynamic changes, total surgical time, and blood loss were recorded. The rates of satisfactory surgical conditions were 6.7%, 72.4%, 89.7%, and 93.3% in groups 0U, 2U, 4U, and 6U, respectively; they were higher in groups 2U, 4U, and 6U than those in group 0U, but there were no significant differences among the groups 2U, 4U, and 6U. The blood loss was higher in group 0U than that in groups 2U, 4U, and 6U (p < .01). Pituitrin was associated with a transient decrease in blood pressures and an increase in heart rate in a dose-dependent fashion, with more pronounced changes in groups 4U and 6U, and these groups also required a higher amount of vasoactive drug to correct hemodynamic changes (p < .05).ConclusionTwo units of pituitrin could provide a satisfactory surgical field with minimal hemodynamic changes for laparoscopic uterine myomectomy.     

Fetal Movement Counting—Effects on Maternal‐Fetal Attachment: A Multicenter Randomized Controlled Trial

Abstract: Background: Women presenting with decreased fetal movement have an increased risk of adverse pregnancy outcomes. Fetal movement counting may be associated with improvement in maternal‐fetal attachment, which in turn, improves pregnancy outcome and postnatal mother–infant attachment. The study aim was to test whether maternal‐fetal attachment differed between groups of mothers who systematically performed fetal movement counting and mothers who followed standard antenatal care where routine fetal movement counting was discouraged. Methods: In a multicenter, randomized trial, 1,123 women were assigned to either systematic fetal movement counting from pregnancy week 28 or to standard antenatal care. This study sample included primarily white, cohabiting, nonsmoking, and relatively well‐educated women. The outcome measure was maternal‐fetal attachment, measured by using the Prenatal Attachment Inventory. Analysis was by intention‐to‐treat. Results: No difference was found between the groups in the scores on prenatal attachment; the means and standard deviations were 59.54 (9.39) and 59.43 (9.35) for the intervention and the control groups, respectively (p = 0.747). The mean difference between the groups was 0.20 (95% CI: 1.02–1.42). Conclusions: Fetal movement counting in the third trimester does not stimulate antenatal maternal‐fetal attachment. This result differs from a previous study where fetal movement counting improved maternal‐fetal attachment. Further research with a focus on possible mediating factors such as levels of stress, concern, and other psychological factors is required. (BIRTH 38:4 December 2011)     

Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial

BackgroundVaginal looseness and decreased sensation during intercourse is prevalent in up to 30%–55% of premenopausal women. The efficacy and safety of CO2 laser have been demonstrated for these indications; however, the effect is temporary, up to 6–12 months. No studies regarding the efficacy and safety of adjuvant laser treatments have been conducted to date.AimTo evaluate the efficacy and safety of a single maintenance CO₂ laser treatment in women with vaginal looseness and a concurrent decline in sexual sensation during intercourse.MethodsThis prospective double-blinded randomized controlled trial included premenopausal women who experienced significant temporary improvement in symptoms following previous treatment with CO2 laser due to the abovementioned indications. Participants were randomized to either a single CO2 laser treatment or a single sham treatment.OutcomesTreatment efficacy evaluated with the female sexual function index (FSFI) and the vaginal health index (VHI).ResultsOverall, 119 women were included in the study. Mean VHI and FSFI scores were significantly higher in the study group compared to the control group at three months post-treatment (17.34±1.39 vs 12.86±2.23, P = .023 and 30.93±1.79 vs 25.78±1.87, P = .044, respectively). In the study group, both VHI and FSFI returned to baseline at six months post-treatment. The median rate of sexual intercourse per month was increased in the study group at three months post-treatment (8 vs 4, P = .011), and returned to baseline at six months post-treatment.Clinical implicationsMaintenance laser treatment provides a temporary non-surgical alternative for women with vaginal looseness and associated sexual dysfunction, though treatment effect seems to be limited to less than 6 months, requiring additional maintenance sessions.Strengths and limitationsThe strengths of the current study include a randomized-sham controlled design. Furthermore, VHI was used as an objective evaluation tool, in addition to the FSFI, and assessment of the rate of sexual intercourse. The homogeneity and the relatively small sample size of the cohort is a limitation, and calls for caution in interpretation of the results, and the use of CO2 laser treatment in different age groups and populations.ConclusionA single maintenance laser treatment in women who previously underwent successful treatment with laser is an effective, well-tolerated, and safe procedure for treating symptoms of vaginal looseness and sexual dysfunction, though effects are temporary.Lauterbach R, Aharoni S, Farago N, et al. Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial. J Sex Med 2022;19:1404–1411.     

Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial

BackgroundProvoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life and consequently negatively affects quality of life. Low-intensity shock wave therapy produces physical forces that lead to pain relief.AimThe aim of this study was to evaluate the feasibility, safety, and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia.MethodsThis is a double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJmm2) using the Medispec, ED-1000 shockwave generator or sham. Participants were assessed at the baseline, and at 1 and 3 months after completing all treatments.OutcomesPain was assessed by both subjective and objective measures. The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point visual analog scale. Secondary outcome measures were changes in pain threshold and tolerance, assessed by a quantitative validated algometer test, the Wong-Baker pain FACES scale, the Female Sexual Function Index and the Patients’ Global Impression of Change scale.ResultsFrom the baseline to 1 month and 3 months after completion of treatment, visual analog scale scores for dyspareunia decreased (8.0 ± 1.4, 5.7 ± 2.3, and 4.4 ± 2.5, respectively, P < .005). For these respective time points, Wong-Baker scores decreased (4.0 ± 0.6, 2.9 ± 1.2, 2.5 ± 1.3, respectively, P < .05); and total Female Sexual Function Index increased (17.9 ± 6.3, 20.9 ± 6.2, 22.5 ± 8, respectively, P < .002). Pain threshold and tolerance measured by the algometer were increased 3 months after completion of the treatment compared with the baseline (69.8 mmHg ± 11.8 vs 22.9 mmHg ± 9.0, P < .01 and 87.7 mmHg ± 35.7 vs 43.3 mmHg ± 14.7, P < .0001, respectively). No changes were observed in any of the measures assessed in the sham group.Clinical ImplicationsWe found a new effective treatment for alleviating the most bothersome symptom in PVD, pain during penetration and intercourse. This resulted in improved sexual function.Strengths & LimitationsThe strengths of this study are the randomized controlled design, the correlated subjective questionnaires, and the use of semiquantitative algometer methodology. The limitations are the relative low number of participants in a single center.ConclusionFor women with PVD, low-intensity shockwave therapy applied at the introitus is a feasible, safe, and effective treatment option that may have a beneficial effect in pain relief and in sexual function.Gruenwald I, Gutzeit O, Petruseva A, et al. Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial. J Sex Med 2021;18:347–352.     

Preoperative Gabapentin for Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Study ObjectiveTo evaluate whether a single dose of gabapentin given preoperatively reduces narcotic use 24 hours after minimally invasive hysterectomy (MIH).DesignRandomized controlled trial.SettingSingle academic-affiliated community hospital.PatientsWomen undergoing MIH for benign indications between June 2016 and June 2017.InterventionsSubjects were randomized to receive a preoperative regimen of acetaminophen, celecoxib, and gabapentin versus acetaminophen and celecoxib alone.Measurements and Main ResultsThe primary outcome assessed was the total amount of narcotics used at 24 hours after surgery. Secondary outcomes included adverse effects from gabapentin use, total narcotics used, and pain scores at 2 weeks after surgery.A total of 129 women were randomized and eligible for analysis in the gabapentin study arm (n = 68) or the control arm (n = 61). Demographic characteristics and surgical details were similar between groups. Narcotics used at 24 hours after surgery totaling 168 versus 161 oral morphine milligram equivalents in the gabapentin and control groups, respectively, did not significantly differ between groups (p = .60). Total narcotics used and pain scores at 2 weeks after surgery and the rates of adverse effects from gabapentin were also similar between study arms.ConclusionSingle-dose, preoperative gabapentin for women undergoing benign MIH does not reduce total opioid use 24 hours after surgery.     

Etonogestrel-Releasing Contraceptive Implant for Postpartum Adolescents: A Randomized Controlled Trial

Study Objective

To compare immediate postpartum insertion of the contraceptive implant to placement at the 6-week postpartum visit among adolescent and young women.

Intraumbilical Oxytocin for the Management of Retained Placenta: A Randomized Controlled Trial

Objective: To evaluate the ability of intraumbilical oxytocin injection as a treatment for retained placenta after vaginal delivery to reduce the incidence of manual removal and postpartum hemorrhage.Methods: A randomized controlled trial was set up in a university and a district general hospital. We recruited 81 women with singleton pregnancies who underwent vaginal delivery and who failed to deliver the placenta after 20 minutes of active management of the third stage of labor. Study subjects were randomized to receive either 1) an intraumbilical injection of oxytocin (20 IU in 20 mL of saline); 2) an intraumbilical injection of saline (20 mL); or 3) no treatment. Outcome measures were expulsion of the placenta within 45 minutes of delivery, need for manual removal of the placenta under anesthesia, and postpartum hemorrhage (defined as a blood loss greater than 500 mL).Results: Women given an intraumbilical injection of oxytocin had a significant increase in spontaneous expulsion of the placenta within 45 minutes of delivery and fewer manual removals of the placenta, compared with women without treatment (odds ratio [OR] 11.6, 99% confidence interval [CI] 1.4, 272.8; and OR 7.4, 99% CI 1.1, 86.5; respectively). When women given intraumbilical oxytocin were compared with women given only intraumbilical saline, the difference was not statistically significant (OR 6.6, 99% CI 0.9, 77.2 for spontaneous expulsion of the placenta; and OR 4.7, 99% CI 0.8, 39.5 for manual removal). There was no significant difference in the incidence of spontaneous expulsion and manual removal of the placenta between women given intraumbilical saline injection and women without treatment (OR 1.8, 99% CI 0.1, 53.9; and OR 1.6, 99% CI 0.1, 22.4; respectively).Conclusion: The results of our study suggest a clinically important beneficial effect of intraumbilical oxytocin injection in the management of retained placenta.     

A Randomized,Controlled Trial of Nurse-Midwifery Care

ABSTRACT: Background : In 1990 a pilot nurse-midwifery program was implemented in a tertiary care hospital in a major western Canadian city. A randomized, controlled trial was conducted to determine if when maternal and newborn patient outcomes were compared, the midwifery program was as effective as traditional, low-risk health care available in the city. Methods : All low-risk women who requested and qualified for nurse-midwifery care were randomly assigned to an experimental or control group. Results : One hundred one women received care from nurse-midwives and 93 received standard care from either an obstetrician or family physician. The rate of cesarean delivery in the nurse-midwife group was 4 percent compared with 15.1 percent in the physician group. The episiotomy rate, excluding cesarean deliveries, for the nurse-midwife group was 15.5percent compared with 32.9 percent in the physician group. The rates of epidural anesthesia for pain relief in labor were 12.9 percent and 23.7 percent, respectively. Statistically significant differences were found for ultrasound examinations, amniotomy, intravenous drug administration during labor; dietary supplements, length of hospital stay, and admission of infants to the neonatal intensive care unit. Conclusions : The results clearly support the effectiveness of the pilot nurse-midwifery program and suggest that more extensive participation of midwives in the Canadian health care system is an appropriate use of health care dollars.     

Home versus Hospital Breastfeeding Support for Newborns: A Randomized Controlled Trial

ABSTRACT: Background: The advantages of breastfeeding have been well established for both mothers and their infants. Existing research reports equivocal effects of early discharge and postpartum home care on breastfeeding success. The purpose of this study was to compare the effects of breastfeeding support offered in hospital and home settings on breastfeeding outcomes and maternal satisfaction for mothers of term and near‐term newborns who experienced standard or early discharge. Methods: In a randomized controlled trial with prognostic stratification for gestational age, 101 term and 37 near‐term (35–37 weeks’ gestational age) mother‐newborn pairs were randomized to either a standard care group (standard care and standard length of hospitalization) or an experimental group (standard hospital care with early discharge and home support from nurses who were certified lactation consultants). Data collection occurred before randomization, at discharge from hospital, and from 5 to12 days postpartum. Primary outcomes included breastfeeding rates and maternal satisfaction. Results: More mothers of term newborns in the experimental group were breastfeeding exclusively at follow‐up (p=0.02) compared with the control group. No significant breastfeeding differences occurred among mothers with near‐term newborns in the experimental and standard care groups. Conclusions: In‐home lactation support appears to facilitate positive breastfeeding outcomes for mothers of term newborns. This may also be a beneficial model of postpartum care for mothers of near‐term newborns; however, further research is required. The findings suggest implications for health caregivers and policy makers with respect to postpartum lactation and health care services. (BIRTH 29:4 December 2002)     

Knee-Chest Postural Management for Breech at Term: A Randomized Controlled Trial

Background: In 3 to 4 percent of all term births, the fetus presents as a breech. The objectives of this trial were to assess if assuming the knee-chest position reduced the frequency of breech presentation at delivery, increased the success of the subsequent external cephalic version, or both, and to determine if this management plan reduced the need for cesarean delivery. Methods: A randomized clinical trial recruited 100 women from two hospitals in Adelaide, South Australia, with a singleton breech presentation and a gestational age equal to or more than 36 weeks. Women in the treatment group were advised to assume the knee-chest position for 15 minutes three times a day for one week. Women in the control group did not perform postural management. All participants were reviewed one week later, and women whose baby remained as a breech presentation were offered an external cephalic version. Results: Postural management did not increase the success of the external cephalic version, reduce the frequency of breech presentation at delivery, or reduce the need for cesarean delivery in women with a breech presentation at term. Conclusions: Findings from this trial included in a meta-analysis of postural management for breech presentation at term suggested that this is not an effective form of care to be offered routinely to women with a breech presentation at term.     

Abdominal Ice after Laparoscopic Hysterectomy: A Randomized Controlled Trial

Study ObjectiveTo assess the impact of abdominal ice packs on opioid use and pain control after laparoscopic hysterectomyDesignRandomized controlled trial.SettingAcademic tertiary care medical center.PatientsTotal of 142 adult women undergoing laparoscopic (either conventional or robotic) hysterectomy were randomized to control (n = 69) or intervention (n = 73). Exclusion criteria included preoperative opioid use, planned intensive care unit admission or same-day discharge, an incision ≥4 cm, and regional anesthesia use.InterventionsSubjects in the intervention group had a large ice pack placed directly on the lower abdomen before leaving the operating room. The ice pack was maintained continuously for 12 hours postoperation, as desired thereafter until discharge, and continued use encouraged after discharge for up to 48 hours.Measurements and Main ResultsTotal opioids administered postoperatively, while inpatient and after dismissal, were assessed in morphine milligram equivalents. Postoperative pain, as well as analgesia acceptability and side effects, were assessed using validated measures: Brief Pain Inventory and Overall Benefit of Analgesia Score. Median morphine milligram equivalent was lower in the intervention group than the controls from inpatient stay on the floor to completion of opioid use as an outpatient (22.5 vs 26.2) but was not statistically significant (p = .79). There was no significant difference between the groups in Brief Pain Inventory assessment of postoperative pain severity (p = .80) or pain interference (p = .36) or Overall Benefit of Analgesia Score total score (p = .88). Most patients in the intervention group were very satisfied with ice pack use (n = 51, 79.7%) and very likely to recommend it to friends or family (n = 54, 83.1%). There were no adverse events related to ice pack use.ConclusionThere was no significant difference in postoperative opioid use or pain assessment with ice pack use after laparoscopic hysterectomy. However, most of the subjects expressed high satisfaction specific to ice pack use and would recommend its use to others, suggesting potential desirability as adjunct therapy in postoperative pain control.     

L-精氨酸治疗胎儿生长受限的效果及其机制探讨

目的 :探讨一氧化氮 (NO)在胎儿生长受限 (FGR)发生、发展中的作用及L 精氨酸 (L Arg)治疗FGR的效果和作用机制。方法 :选择符合入选条件的FGR患者 6 6例 ,其中L Arg组 30例 ,常规治疗组 36例。正常初产妇 30例为正常组。监测治疗前后胎儿生长发育参数、脐血流参数、孕妇血液流变学参数及孕妇血清NO水平变化 ,脐静脉血清NO水平 ,并比较新生儿出生体重。结果 :治疗后 ,L Arg组与常规治疗组比较 :①L Arg组胎儿双顶径 (BPD)、股骨长 (FL)及腹围(AC)的增长幅度较高 (P均 <0 .0 1) ;②搏动指数 (PI)、阻力指数 (RI)较低 (P <0 .0 1,P <0 .0 5 ) ,快速血流比值 (FBVR)较高 (P <0 .0 1) ;③全血低切粘度 (LBV)值较低 (P <0 .0 5 ) ;④孕妇血清及脐静脉血清NO水平较高 (P均 <0 .0 1) ;⑤新生儿出生体重较高 (P <0 .0 5 )。结论 :NO合成和 (或 )释放减少可能在FGR的发生、发展中起重要作用。L Arg结合常规治疗较单纯常规治疗具有更好的临床疗效     

Efficacy of Non-ablative Laser Therapy for Lichen Sclerosus: A Randomized Controlled Trial

ObjectiveThe aim of this randomized controlled trial was to evaluate the safety and efficacy of neodymium: yttrium aluminum garnet laser treatment of lichen sclerosus (LS) by comparing it with topical corticosteroid treatment.MethodsA total of 40 female patients with vulvar LS were randomized 1:1 into a study (laser) group and a control (topical corticosteroids) group. The laser group received three laser treatments. Blinded evaluators evaluated biopsies and graded improvement on clinical photographs at baseline and at 3 months. Patients graded the intensity of symptoms on a 0 to 10 visual analogue scale at baseline and 1-, 3-, and 6-month follow-up. Patients also rated the tolerability of laser treatments, and side effects were monitored. (Canadian Task Force classification I)ResultsLaser treatment discomfort was on average 1.5 of 10 on the visual analogue scale. At 1- and 3-month follow-up, patients in the laser group had significantly greater improvement in LS symptoms (burning, itching, pain, and dyspareunia), better patient satisfaction, and greater reduction of sclerosis than patients in the topical corticosteroid group. At 6-month follow-up, the improvement of symptoms in the laser group was still significant. The correct order of photographs (before and after treatment) was assigned significantly more often in the laser-treated patients compared with the control group.ConclusionLaser therapy for LS caused minimal patient discomfort during the treatment, with no adverse effects, and demonstrated better efficacy than in the control group, with significant improvement lasting up to 6 months. Laser therapy is a promising option for patients not responding to topical corticosteroid therapy or patients wishing to reduce long-term corticosteroid maintenance use.     

胎儿生长受限对胎儿脑神经发育的影响

胎儿生长受限（fetal growth restriction,FGR）可引起胎儿及新生儿近远期发育异常和成年期的严重神经系统疾病,因此FGR对胎儿及新生儿脑神经发育的影响已成为近年来的研究热点。人类研究和动物实验结果显示,FGR的发病时间、FGR的严重程度和分娩时孕周与胎儿脑神经发育密切相关。大脑中动脉多普勒超声、脑-胎盘率可评估FGR胎儿脑血流动力学,相位对比磁共振成像可监测胎儿脑血流及脑结构。早发型和晚发型FGR对子代脑神经发育的影响不同,FGR还可导致胎儿脑结构和功能异常,脑室内出血发生率增加。综述FGR对胎儿脑神经发育影响的研究进展,以期加强临床对FGR胎儿的管理,改善其近远期结局。     

A Randomized Trial of Electronic Fetal Monitoring in Preterm Labor: Mothers'Views

ABSTRACT: To determine if perceptions of preterm labor and birth differed between women who were monitored by electronic fetal monitoring (EFM) or by periodic auscultation, 135 subjects were randomly assigned to one of two treatment groups on admission to a tertiary perinatal care setting. The first group received external monitoring by continuous Doppler and tocodynamometer when membranes were intact, and with an internal fetal scalp electrode and pressure catheter once membranes were ruptured. The second group received periodic monitoring with a DeLee fetoscope or amplified Doppler. All women were cared for on a one-to-one basis by expert study nurses. Subjects completed a questionnaire about their labor experience during their postpartum hospital stay. There was no statistically significant difference between the two groups on the study measures [T2(7,81) = 13.65; F = 1.82; P > 0.05]. Forty-four percent of the variance in women's global evaluation of labor was explained by their perceptions of nursing support. These findings suggest that mothers' perceptions of their preterm labor are less influenced by the technologic interventions used than by the supportive care received from nurses.     

Surgical Excision Versus Ablation for Superficial Endometriosis-Associated Pain: A Randomized Controlled Trial

Study Objective

To compare surgical excision and ablation of endometriosis for treatment of chronic pelvic pain.

胎儿生长受限的病因研究进展

胎儿生长受限（FGR）又称宫内生长受限（IUGR）,是指胎儿在母体、胎儿自身以及环境因素影响下未达到其生长潜能,是产科常见疾病之一,也是我国围生儿死亡的主要原因之一。FGR可以引起多种围生儿不良妊娠结局,包括胎儿窘迫、低出生体质量儿、早产等,且与多种远期或成年疾病相关,如代谢综合征、心血管疾病。预防FGR的发生对于提高人口素质有重要意义,但引起FGR的因素众多,主要包括母体因素、胎儿因素及胎盘、脐带因素,各种因素并不只以单一的形式存在,全面了解其发生因素有助于预防该疾病的发生。对FGR的病因进行综述,以期为该疾病的预防提供理论基础。。