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

BACKGROUND: Vaginal 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. AIM: To 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. METHODS: This 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. OUTCOMES: Treatment efficacy evaluated with the female sexual function index (FSFI) and the vaginal health index (VHI). RESULTS: Overall, 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 IMPLICATIONS: Maintenance 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 LIMITATIONS: The 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. CONCLUSION: A 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.

The efficacy and safety of a single maintenance laser treatment for stress urinary incontinence: a double-blinded randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: To evaluate the efficacy and safety of a single carbon dioxide (CO2) laser maintenance treatment in women previously treated successfully with laser for stress urinary incontinence (SUI), who have demonstrated a decline in treatment effect. METHODS: Women aged 40-70 years who experienced temporary significant improvement in symptoms following CO2 laser treatments for SUI were randomized to either the treatment group or the sham treatment control group. Cough test results, 1-h pad weights and scores on the Urogenital Distress Inventory (UDI6), the International Consultation of Incontinence Questionnaire (ICIQ-UI) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) were obtained at baseline and 3 and 6 months. RESULTS: Of 183 women screened, 131 were included in the final analysis. Demographic characteristics and baseline measures in the outcome tests were similar between the groups. Statistically significant improvements were demonstrated in the study compared to the control group at 3 months post-treatment in positive cough test (44.4% vs. 79.4%, P = 0.002), mean pad weight test (2.3 g ± 1.3 vs. 5.6 ± 1.1, P < 0.001), mean UDI-6(24.7 ± 12.1 vs. 45.1 ± 13.6 SD, P = 0.004), mean ICIQ-UI (16.5 ± 4.3 vs. 10.3 + 3.8, P = 0.003) and mean PISQ-12 (21.3 ± 6.8 vs. 36.6 ± 7.5, P = 0.003). However, values at 6 months post-treatment were similar to those at baseline. CONCLUSIONS: Our results suggest that a single maintenance laser treatment for reducing symptoms of SUI is transiently effective, well tolerated and safe. This treatment modality provides alternative non-surgical therapy for women with SUI.

Interpregnancy interval following missed abortion and the risk for preterm birth.

OBJECTIVE: Short inter-pregnancy interval (IPI) of <18 months following a live birth, has been associated with adverse pregnancy outcome. This study aimed to evaluate whether a short IPI following a medically treated missed abortion (MA) poses similar perinatal risks in a subsequent pregnancy. STUDY DESIGN: The retrospective analysis included patients with history of an MA at up to 10 weeks of gestation, treated with misoprostol (pgE1) only, and with a documented subsequent live pregnancy (2010-2022). 1110 Patients were allocated into two groups: IPI ≤18 months and IPI >18 months. The primary outcome was the risk for a spontaneous preterm birth (PTB) <37 weeks of gestation in the consecutive pregnancy. Secondary outcomes included maternal and neonatal adverse outcomes. Statistical analysis was performed using the Statistical Program for Social Sciences for Windows version 26 (SPSS Inc, Chicago, IL). RESULTS: The cohort included 1,110 patients: 430 (38.74 %) patients with IPI <18 months and 680 (61.26 %) patients with IPI >18 months. The characteristics of the two groups were not significantly different. The rates of spontaneous PTB <37 and <34 weeks of gestation were significantly higher in the short vs. long IPI cohort (16.28 % vs. 7.06 % and 6.74 % vs. 5.0 %, respectively, p < 0.05). These patients also had a higher risk for Cesarean delivery (31.63 % vs. 23.34 %, p = 0.005) and postpartum hemorrhage (4.42 % vs. 2.06 %, p = 0.029) compared to patients with IPI >18 months. The observed differences remained statistically significant even after adjusting for potential confounding variables using multiple regression analysis. No other significant differences in neonatal or maternal outcomes were noted. CONCLUSION: Short IPI (≤18 months) following a medical treatment MA may be associated with an increased risk of PTB, Cesarean delivery and PPH.

Interpregnancy interval after vacuum delivery and subsequent perinatal outcomes.

OBJECTIVE: To evaluate whether a short interpregnancy interval (IPI) after vacuum extraction (VE), poses similar perinatal risks in a subsequent pregnancy. METHODS: This was a retrospective, single-center cohort study between 2011 and 2021. Nulliparous women with term, singleton VE deliveries and with known pregnancy outcomes in their subsequent pregnancy were eligible for inclusion in the study. Each woman was allocated into one of two groups based on the IPI, <18 months and between 18 and 60 months. The primary outcome was the risk of spontaneous preterm birth (PTB) <37 weeks in the consecutive birth. RESULTS: We included 1094 pregnancies: 212 (19.4%) with IPI <18 months and 882 (80.6%) with IPI between 18 and 60 months following the previous VE delivery. The VE characteristics were comparable between the groups. Young maternal age was a risk factor for a short IPI (28.0 ± 4.8 vs 30.3 ± 4 years, P < 0.01). Spontaneous PTB <37 weeks was significantly higher in the IPI <18 months group with 18-60 months (7.1% vs 2.6%, P = 0.002). Polynomial regression analysis also confirmed a significantly increased risk of preterm birth <37 weeks (P < 0.01). Short IPI <18 months was also associated with an increase in the risk of low birthweight <2500 g (6.1% vs 2.8%, P = 0.02) and admission to the neonatal intensive care unit (6.1% vs 2.6%, P = 0.013). The incidence of recurrent VE, albeit significant (2.3% vs 4.9%, P = 0.049), was low in both groups. No differences were noted in any of the other secondary outcomes. CONCLUSION: Short IPI (<18 months) following term VE delivery is associated with higher neonatal risks, particularly PTB, in the subsequent pregnancy. These findings are particularly important when counseling women planning an optimal IPI.

Delivery mode after cervical ripening among patients with no prior vaginal births.

PURPOSE: To compare mode of delivery and maternal and neonatal outcomes using cervical ripening balloon (CRB) for induction of labor (IOL) in nulliparous patients vs. those undergoing first trial of labor after cesarean (TOLAC). METHODS: Retrospective cohort study including data from two tertiary medical centers. Included were all patients with a singleton pregnancy and a gestational age > 37+0 weeks and no prior vaginal birth undergoing IOL with CRB. Nulliparous patients (nulliparous group) were compared to patients with one prior cesarean delivery (CD) and no prior vaginal delivery (TOLAC group). Patients who withdrew consent for trial of labor at any time in both groups were excluded. The primary outcome was mode of delivery. RESULTS: Overall, 161 patients were included in the TOLAC group and 1577 in the nulliparous group. The rate of CD was similar in both groups and remained similar after adjusting for confounders (29.8 % vs. 28.9 %, p = 0.86, OR 1.1, 95 %, CI 0.76-1.58). CD due to fetal distress was more common in the TOLAC group (75 % vs. 56 %, p = 0.014). Other maternal outcomes and neonatal outcomes were similar in the two groups. CONCLUSION: Comparable vaginal delivery rates may be achieved in patients with or without a previous CD attempting their first trial of labor, with a cervical ripening balloon for labor induction, without increasing adverse maternal or neonatal outcomes.

Does delayed vacuum-assisted delivery harbor greater maternal or neonatal complications?

OBJECTIVE: To compare maternal and fetal outcomes between early (<2 h) and delayed (>2 h) vacuum extraction (VE) deliveries. METHODS: We performed a retrospective cohort study in a single, university-affiliated medical center (2014-2021). We included term singleton pregnancies delivered by VE, allocated into one of two groups according to second stage duration: <2 h or >2 h. Primary outcome was maternal composite adverse outcome (included chorioamnionitis, 3-4 degree lacerations, and postpartum hemorrhage [PPH]). RESULTS: We included 2521 deliveries: 2261 (89.6%) with early VE and 260 (10.4%) with delayed VE. Study groups' characteristics were not different, except of parity. Maternal composite outcome almost reached a significance (P = 0.054) comparing between the groups. Comparing second stage length up to 2 h versus more, there was similar rate of advance maternal lacerations. However, extending the second stage to more than 3 h was associated with third degree lacerations compared to 2-3 h (9.8% vs 3%, P = 0.011). There were significantly more PPH events in the later VE group (P = 0.004), but the need for blood transfusions was similar. The rates of 5 min Apgar score ≤7 (P = 0.001) and umbilical artery pH <7.0 were significantly higher in group 2 compared with group 1. The effect was much more pronounced when second stage was >3 h. After conducting multiregression analysis, the results became insignificant. CONCLUSION: Our study suggests that VE performed in the late second stage of labor, up to 3 h, is safe as VE performed in the early stages regarding maternal and neonatal outcomes. Extra caution is needed with extended second stage to more than 3 h.

Fixed-time interval vs on-demand oral analgesia after vaginal delivery: a randomized controlled trial.

BACKGROUND: Scheduled administration of analgesics was proven superior to on-demand dosing following cesarean deliveries. However, this protocol was not compared after vaginal delivery. OBJECTIVE: To compare the efficacy of a fixed- vs on-demand analgesic protocol for the management of pain in the first 24 hours after a vaginal delivery. STUDY DESIGN: This randomized, prospective, controlled trial was conducted at a single tertiary medical center between June 1, 2020 and June 30, 2022. Vaginally delivered patients were randomly assigned to receive oral analgesics (paracetamol 1 g + ibuprofen 400 mg) either every 6 hours for the first 24 hours postpartum (scheduled analgesia group) or as needed (on-demand group). Pain level during the first 24 hours postdelivery was measured using a 10-point visual analog scale. RESULTS: A total of 200 patients were randomized 1:1 to the 2 cohorts. Baseline and delivery characteristics, including oxytocin augmentation, epidural anesthesia, episiotomy rate, and neonatal birthweight, were comparable between groups. Patients in the scheduled group received more paracetamol and ibuprofen doses in the first 24 hours (2.9±1.3 and 2.9±1.2 doses vs 0.8±1.1 and 0.7±1.1 doses, respectively; P<.001). Pain score was comparable between study groups (5.31±1.92 vs 5.29±1.67; P=.626) even after subanalysis for primiparity, episiotomy, and vacuum-assisted delivery (P>.05). However, patients on a fixed treatment schedule were more likely to breastfeed their baby (98% vs 88%; P=.006) as than those receiving treatment on demand. In addition, they were more satisfied with their labor and delivery experience, as evaluated by Birth Satisfaction Scale questionnaires quality control (37.9±4.7 vs 31.1±5.2; P=.0324), patient attributes (35.0±5.1 vs 30.3±6.3; P=.0453), and stress experienced (58.1±8.5 vs 50.1±8.3; P=.0398). No side effects or adverse outcomes were reported in either group. CONCLUSION: A scheduled analgesic protocol for postpartum pain management following vaginal delivery revealed similar pain scores compared with an on-demand protocol, although it was associated with higher breastfeeding rates and higher maternal satisfaction.

The optimal induction timing in prelabor rupture of membranes: a retrospective study.

OBJECTIVE: Term prelabour rupture of membrane (PROM) occurs in 8% of term deliveries, but it is unclear when to initiate induction. Our objective was to assess the optimal timing of oxytocin induction in the management of term PROM in terms of maternal and neonatal outcomes. METHODS: A retrospective cohort study was performed at a single tertiary care center from 2010 to 2020. All singleton pregnancies with PROM beyond 37 weeks gestation, without regular uterine contractions, were included. Eligible women were divided into three groups according to the timing of oxytocin induction (≤12; 12-24; ≥24 h) following PROM. RESULTS: Of 9,443 women presented with the term PROM, 1676 were included. They were classified according to the timing of oxytocin induction initiation following PROM: 1,127 within 12 h; 285 within 12-24 h; 264 after 24 h. There were no significant differences in baseline demographic characteristics between groups. Women who presented at our emergency department were induced earlier delivered significantly sooner than those who received oxytocin later (45 vs. 28.2 vs. 23.2 h, respectively, p < .001. Maternal infection rate was similar and unrelated to oxytocin starting time. Induction at <12 h from PROM was associated with reduced rate of antibiotic administration compared with other timings (26.8% vs. 38.6% vs. 33.33%, respectively; p < .001), and the same was found for neonatal composite adverse outcomes (RR = 1.27, p = .0307). CONCLUSION: In term PROM, early induction (within 12 h of PROM) may be recommended to reduce the time-do-delivery interval and increase the delivery rate within 24 h. It may be of economic significance and improve women satisfaction. Furthermore, early induction may also improve neonatal outcomes, without worsening maternal outcomes.

Continuous vs intermittent induction of labor with oxytocin in nulliparous patients: a randomized controlled trial.

BACKGROUND: Oxytocin is considered the drug of choice for the induction of labor, although the optimal protocol and infusion duration remain to be determined. OBJECTIVE: This study aimed to assess whether the duration of oxytocin infusion increases 24-hour delivery rates and affects the length of time-to-delivery and patient's experience. STUDY DESIGN: A randomized controlled trial was performed at a single tertiary medical center, between January 1, 2020 and June 30, 2022. Nulliparous patients with a singleton pregnancy at a vertex presentation and a Bishop score ≥6 were randomly assigned to receive either continuous (16 hours, with a 4 hours pause in between infusions) or intermittent (8 hours, with a 4 hours pause in between infusions) oxytocin infusion, until delivery. In both groups, infusion was halted when signs of maternal or fetal compromise were observed. Randomization was conducted with a computer randomization sequence generation program. The primary outcome was delivery within 24 hours from the first oxytocin infusion and the secondary outcome included time-to-delivery, mode of delivery, and additional maternal and neonatal outcomes. Seventy-two patients per group were randomized to reach 80% statistical power with a 20% difference in the primary outcome according to previous studies. RESULTS: A total of 153 patients were randomized, 72 to the continuous oxytocin infusion group and 81 to the intermittent infusion group. The total oxytocin infusion time was similar between the groups. Patients in the continuous arm were more likely to deliver within 24 hours from oxytocin initiation (79.73% vs 62.96%, P<.05), and had a shorter oxytocin-to-delivery time interval, compared with patients receiving intermittent treatment (9.3±3.7 hours vs 21±11.7 hours, P<.001). Furthermore, time from ruptured membranes to delivery was shorter (9.3±3.7 hours vs 21±11.7 hours; P<.0001) and chorioamnionitis was less frequent (9.46% vs 21%; P<.05) in the continuous compared with the intermittent arm. Cesarean delivery rate was 20% in both groups (P=.226). There was no difference in postpartum hemorrhage, or adverse neonatal outcomes between the groups. Patients receiving continuous oxytocin infusion were more satisfied with the birthing experience. CONCLUSION: Continuous infusion of oxytocin for labor induction in nulliparous patients with a favorable cervix may be superior to intermittent oxytocin infusion, because it shortens time-to-delivery, decreases chorioamnionitis rate, and improves maternal satisfaction, without affecting adverse maternal or neonatal outcomes.

Cervical ripening with multiple medical or combined induction methods: Risks of subsequent preterm birth in nulliparous women.

OBJECTIVE: To determine the impact of combined medical and medical/mechanical methods for cervical ripening on the risk of preterm birth in subsequent pregnancy, in nulliparous women. METHODS: A retrospective cohort study of nulliparous women with term singleton gestations induced by single or combined methods at one center who had their subsequent second birth in the same center. Study groups were compared with a control group of nulliparous women not induced. The primary outcome was risk of preterm labor in the second consecutive birth. Secondary outcomes included neonatal and maternal complications. RESULTS: Cohort included 1277 nulliparous women who underwent cervical ripening by single or combined methods. The study group consisted of 942 women induced by one dose of prostaglandin E2 , 248 women induced by combined methods, and 87 women induced by a mechanical method. The control group consisted of 3903 women. Demographic data of the groups were comparable. Rates of spontaneous preterm birth and early spontaneous preterm birth in the subsequent births did not differ between the groups. CONCLUSION: Cervical ripening with combined methods or multiple medical methods did not increase the rate of subsequent spontaneous preterm births in nulliparous women or change the neonatal and maternal complications rate.

Which part of cervical length is predictive of preterm birth in women with cerclage?

OBJECTIVE: To evaluate the predictive value of transvaginal ultrasonography measures: total cervical length (TCL), length to internal OS (LIO) and external OS (LEO) from the cerclage following cerclage placement, for spontaneous preterm birth (PTB). METHODS: A retrospective cohort at a single tertiary care center (2010-2020). Women with McDonald cerclage were evaluated during the 2nd and 3rd trimesters for cervical measurements: TCL, LIO, LEO. The primary outcome was PTB < 37 weeks. Demographic data, obstetric history, delivery information and serial cervical length measurements were collected. Subgroup analyses were performed to evaluate cervical length parameters (as described) and PTB rates prior to 34, 32 and 28 weeks of gestation. RESULTS: Of 66 women enrolled, 36.4% (n = 24) had PTB. There were no differences in the obstetrical history and demographic information (p > .05) nor indication for cerclage (p = .369). Cervical length measurements at 20-24 weeks demonstrated a shorter TCL & LIO (22.69 vs. 33.86 mm, p = .001; 9.25 vs. 15.9 mm, p = .0042; respectively) in the preterm group. The LEO was similar in both groups. This pattern was also shown in a subgroup analysis (PTB < 34, 32 and 28 weeks). CONCLUSION: Cervical length from internal OS to cerclage and total cervical length have a predictive value for PTB in women with a cervical cerclage, regardless of the indication for cerclage/previous pregnancy outcomes. Our data emphasize the importance of follow-up cervical length measurements of women with a cervical cerclage, and especially cervical length from internal OS to cerclage as those women may need additional care.

Vaginal progesterone treatment for the prevention of preterm birth and intrahepatic cholestasis of pregnancy: A case-control study.

INTRODUCTION: Intrahepatic cholestasis of pregnancy (ICP) is associated with a distinctive maternal pruritus, abnormal liver function tests, raised serum total bile acids, and increased rates of adverse fetal outcomes, including intrauterine fetal death. Progesterone has been implicated in the pathogenesis of ICP. We aimed to evaluate whether the incidence of ICP is altered in women receiving long-term daily vaginal progesterone, indicated for a short cervical length. STUDY DESIGN: A matched 1:3 case-control study of pregnant women between January 2014 and January 2019. Study cases included pregnant women with the diagnosis of ICP. Control cases were women without ICP. The primary outcome was the rate of vaginal progesterone treatment among the groups. RESULTS: The use of vaginal progesterone throughout pregnancy was higher in the ICP group compared with the control group (8/174 [4.6 %] versus 6/522 [1.1 %], respectively, P = 0.03, odds ratio 4 [95 % confidence interval 1.4-11.7]). CONCLUSIONS: Pregnant women treated with long-term vaginal progesterone preparations for the prevention of preterm birth are at increased risk of developing ICP. In the presence of pruritus during pregnancy, we recommend an early consultation and diagnostic test to confirm or rule-out ICP.