Sleep disturbances in late pregnancy: associations with induction of labor.

PURPOSE: Sleep disturbances, which are common during pregnancy, may compromise labor. Nevertheless, little is known about associations between sleep disturbances and the likelihood of ending up induction of labor (IOL). Accordingly, we aimed to evaluate the connections between sleep disturbances during pregnancy and IOL. METHODS: Altogether 1778 women from the FinnBrain Birth Cohort Study with gestation weeks over 37 + 6 were enrolled in the study. The women were divided into IOL (n = 331) and spontaneous onset of labor (SOL, n = 1447) groups. Sleep disturbances in late pregnancy were evaluated using the Basic Nordic Sleep Questionnaire. Logistic regression analyses were conducted with adjustments for age, body mass index, parity, smoking, and depressive symptoms. RESULTS: Sleep disturbances were frequent in both IOL and SOL groups. In the IOL group 43.0% and in the SOL group 39.0% had poor general sleep quality (P = 0.186). Nocturnal awakenings occurred most commonly, in 94.0% and 93.9%, respectively (P = 0.653). In the IOL group, more women (22.7%) were habitual snorers than in the SOL group (17.0%, P = 0.017), however, the difference lost the statistical significance in adjusted analysis (P = 0.848). Women in the IOL group were more likely to be short sleepers (< 7 h) compared to those in the SOL group (20.2% and 15.4%, respectively, P = 0.034) with no difference after adjustment (P = 0.133). The two groups showed no differences in sleep loss (P = 0.252). CONCLUSIONS: Deterioration in sleep quality was noticeable in pregnant women, but it was unconnected with IOL. As the frequency of IOL is increasing, more research for related risk factors is needed.

Labor induction at 41+0 gestational weeks or expectant management for the nulliparous woman: The Finnish randomized controlled multicenter trial.

INTRODUCTION: Neonatal and maternal risks increase in term pregnancy as gestational age advances and become increasingly evident post-term. Management practices of late- and post-term pregnancies vary, and the optimal time point for intervention by labor induction is yet to be determined. MATERIAL AND METHODS: This randomized controlled trial of 381 nulliparous women with unripe cervices compared labor induction at 41+0 gestational weeks (early induction) with expectant management and labor induction at 41+5 to 42+1 gestational weeks (expectant management). This multicenter study included all five university hospitals and the largest central hospital in Finland. The study period was 2018-2022. Participants were randomized to either early induction (48.8%, n = 186) or expectant management (51.2%, n = 195) with equal randomization ratios of 1:1. This was a superiority trial, and the primary outcomes were rates of cesarean section (CS) and composite of adverse neonatal outcomes. The trial was registered at the ISRCTN registry (ISRCTN83219789, https://doi.org/10.1186/ISRCTN83219789). RESULTS: The rates of CS (16.7% [n = 31] vs. 24.1% [n = 47], RR 0.7 [95% CI: 0.5-1.0], p = 0.07) and a composite of adverse neonatal outcomes (9.7% [n = 18] vs. 14.4% [n = 28], RR 0.7 [95% CI: 0.4-1.2] p = 0.16) did not significantly differ between the groups, but the operative delivery rate was lower in the early induction group than in the expectant management group (30.6% [n = 57] vs. 45.6% [n = 89], p = 0.003). The rates of hemorrhage ≥1000 mL and neonatal weight ≥4000 g were also lower in the early induction group, as was the vacuum extraction rate in women with vaginal delivery. Of the women with expectant management, 45.6% (n = 89) had spontaneous onset of labor. No perinatal deaths occurred, but one case of eclampsia appeared in the expectant management group. CONCLUSIONS: Offering labor induction to nulliparous women at 41+0 gestational weeks may decrease the probability of operative delivery, postpartum hemorrhage, and neonatal weight ≥4000 g. However, this study was underpowered to affirm the trends of rising rates of CS and adverse neonatal outcomes in the expectant management group. Thus, expectant management could remain an option for some, as one in two women with expectant management had a spontaneous onset of labor.

Depressive symptoms and sleep disturbances in late pregnancy: Associations with experience of induction of labor with a catheter.

OBJECTIVE: Depressive symptoms and sleep disturbances have been found to be associated with negative labor experiences, particularly an increased level of pain. However, the associations between maternal depressive symptoms and sleep disturbances and the experience of induction of labor (IOL) remain unknown. In this study, we evaluated these associations with balloon catheter IOL. STUDY DESIGN: A prospective study was conducted on 106 women with planned IOL. Depressive symptoms were evaluated with The Edinburg Postnatal Depression Scale (EPDS) and sleep disturbances with the Basic Nordic Sleep Questionnaire (BNSQ) at the beginning of IOL. The IOL experience was investigated both during the IOL and postpartum with the same nine visual analogue scale (VAS) questions. RESULTS: Regarding sleep disturbances, during the IOL, women with worse general sleep quality were less satisfied (P = 0.019), less relaxed (P = 0.008), experienced more pain in general (P = 0.002) and reported higher contraction frequency (P = 0.003). Furthermore, women who experienced difficulties falling asleep were less relaxed (P = 0.009), reported more general pain (P < 0.001) and contraction pain (P = 0.005), while those with more daytime sleepiness reported less contraction pain (P = 0.033). In postpartum, women with worse general sleep quality reported more general pain (P = 0.003), while women with longer sleep duration and those with higher sleep loss reported more anxiety (P = 0.009 and P = 0.024, respectively). Additionally, women who woke up too early in the morning were less satisfied (P = 0.042), less relaxed (P = 0.004) and reported more general pain (P = 0.018). However, those who experienced more frequent nocturnal awakenings reported being more relaxed (P = 0.014) and having less general pain (P = 0.033). Higher depressive symptoms were associated with a higher frequency of contractions during IOL (P = 0.030), but with less general pain in postpartum (P = 0.027). CONCLUSIONS: Women with sleep disturbances during pregnancy were more likely to report more negative experiences during the IOL. Specifically, they reported more pain, feeling less relaxed and they were less satisfied with IOL. Conversely, the association between depressive symptoms and the experience of IOL seemed weaker. Thus, the quality of sleep of pregnant women is important for a better experience of IOL.

Experiences of induction of labor with a catheter - A prospective randomized controlled trial comparing the outpatient and inpatient setting.

INTRODUCTION: Approximately every fourth labor is induced. In Finland, when labor is induced, it is commonly carried out with a catheter in the inpatient (IP) setting. However, in uncomplicated, full-term pregnancies, induction of labor (IOL) in the outpatient (OP) setting is also possible. Nevertheless, there is only a limited amount of information about the experiences of IOL in OP setting. Our study compared the experiences of catheter IOL in OP and IP settings. MATERIAL AND METHODS: We performed a prospective randomized study, including 113 women with uncomplicated full-term pregnancies with planned IOL. After catheter insertion, women were randomized into OP or IP settings: after dropouts, there were 53 women in the OP group and 54 in the IP. The experiences of IOL were evaluated with three sets of visual analog scale (VAS) questionnaires: the general experience questionnaire (eight questions), the concurrent induction experience questionnaire (1, 5, 9, 13 hours; nine questions) and the postpartum experience questionnaire (14 questions). RESULTS: Both groups had low VAS scores, indicating good experiences of IOL. Women in the OP group were less satisfied (mean VAS difference Δ = 7.8, P = .015) and more anxious (Δ = 4.8, P = .008) than were women in the IP group. In the course of the IOL, all women became less satisfied (Δ = 8.4, P = .001), had more contraction pain (Δ = 8.9, P = .020) and had a higher frequency of contractions (Δ = 9.9, P = .004) but they were more relaxed and experienced less fear (Δ = 6.9, P = .036, Δ = 5.3, P = .001, respectively). There was no interaction between group and time. According to the postpartum experience questionnaire, both groups had a similar good general experience of IOL (P = .736) but the OP group had more fear (Δ = 9.5, P = .009) and was more anxious (Δ = 9.0, P = .007). Most of the women would choose catheter IOL in a subsequent pregnancy (OP 82.6%, IP 87.0%). CONCLUSIONS: The women in the OP setting were less satisfied and more anxious than were the women in the IP setting. However, the differences were marginal and the general experience after IOL was good. IOL in an OP setting is thus a viable option in low-risk full-term pregnancies. Therefore, when using catheter IOL, both setting options should be available.

Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings have become the most preferred surgical treatment for female urinary incontinence. OBJECTIVE: To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence. INTERVENTION: Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires. RESULTS AND LIMITATIONS: A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups. CONCLUSIONS: Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen. PATIENT SUMMARY: Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00379314.

Dynamic MRI confirms support of the mid-urethra by TVT and TVT-O surgery for stress incontinence.

OBJECTIVE: To study changes in mid-urethral function with dynamic MRI in stress urinary incontinent women undergoing either tension-free vaginal tape (TVT) or TVT-obturator sling operations. DESIGN: Prospective clinical study. SETTING: University hospital. SAMPLE: Forty-two parous women with stress urinary incontinence recruited to dynamic magnetic resonance imaging before and after mid-urethral sling surgery. Control group of 16 healthy women. METHODS: Dynamic magnetic resonance imaging at rest, during pelvic floor muscle contraction, coughing and voiding with a bladder volume of 200-300 ml. X- and Y- coordinates were used to determine the location of the mid-urethra during these activities. MAIN OUTCOME MEASURES: Changes in mid-urethral position after TVT and TVT-obturator operations during the different activities. RESULTS: Postoperatively the women could elevate their mid-urethra by pelvic floor muscle contraction significantly higher than before the operation (p<0.05). Despite a different support angle between the TVT and the TVT-O mid-urethral slings, we could not see any differences in the movement patterns. CONCLUSION: Mid-urethral slings support the mid-urethra and restrict downward movement during different activities. Movement patterns are similar after TVT and TVT-O operations.

A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results.

INTRODUCTION AND HYPOTHESIS: This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate. METHODS: Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires. RESULTS: At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups. CONCLUSION: The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.

Dynamic magnetic resonance imaging of the behavior of the mid-urethra in healthy and stress incontinent women.

OBJECTIVES: Support of the mid-urethra is thought to be an essential element of urinary continence in the female. Our aim was to image the behavior of the mid-urethra in healthy volunteers and in stress urinary incontinence (SUI) patients by dynamic magnetic resonance imaging (MRI). DESIGN: Prospective study. SETTING: Gynecology outpatient clinic association with Department of Radiology in University Hospital of Kuopio, Finland. SAMPLE AND METHODS: Fifteen healthy volunteers and 40 SUI women underwent dynamic MRI at rest, during pelvic floor muscle contraction, coughing and voiding with a bladder volume of 200 ml. Our aim was to determine the precise location and movement of the mid-urethra during these activities. MAIN OUTCOME MEASURE: The co-ordinate location and movement of the mid-urethra. RESULTS: Continent volunteers can elevate their mid-urethra significantly higher than incontinent women. Moreover, the mid-urethra of incontinent women rotated significantly more dorsocaudally during straining and coughing than in continent women. CONCLUSIONS: Elevation of the mid-urethra was more marked in continent compared to urinary incontinent women on pelvic floor muscle contraction suggesting sufficient support of the urethra. Downward movement of the mid-urethra was more significant in stress incontinent women than in continent volunteers.

A randomized trial comparing TVT with TVT-O: 12-month results.

The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.

Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial.

OBJECTIVE: To compare the intraoperative and immediate postoperative performance of the retropubic tension-free vaginal tape (TVT) procedure with that of the transobturator tension-free vaginal tape (TVT-O) procedure as primary treatment for female urinary stress incontinence. METHODS: Randomized multicenter comparative trial including four university hospitals and three central hospitals in Finland. Assessment preoperatively and 2 months postoperatively included a cough stress test and the following condition-specific quality of life questionnaires: the Urinary Incontinence Severity Score (UISS), the Detrusor Instability Score, the Incontinence Impact Questionnaire-Short Form, the Urogenital Distress Inventory-Short Form, and a visual analog scale (VAS). Operation time, theater time, hospital stay, intraoperative and immediate postoperative complications were recorded. RESULTS: Of the 273 originally randomized patients, 267 underwent the allocated operation, 136 in the TVT group and 131 in the TVT-O group. No significant differences in objective or subjective cure rates were detected. Patients in the TVT-O group had a significantly longer hospital stay, needed significantly more postoperative opiate analgesia and had significantly more complications than the patients in the TVT group. Patients in both groups had a significant postoperative improvement in quality of life, as indicated by the results of all the questionnaires used, with no difference between the groups. CONCLUSION: The TVT and the TVT-O procedures perform equally in terms of objective and subjective cure. The statistically significant higher complication rate in the TVT-O group is not regarded as clinically significant. CLINICAL TRIAL REGISTRATION: (www.ClinicalTrials.gov), NCT00379314 LEVEL OF EVIDENCE: I.