OBJECTIVE: The aim of this study was to evaluate regular (4-hourly prior to each oral misoprostol dose with amniotomy when feasible) compared with restricted (only if indicated) vaginal assessments during labor induction with oral misoprostol in term nulliparous women MATERIALS AND METHODS: We performed a randomized trial between November 2016 and September 2017 in a university hospital in Malaysia. Our oral misoprostol labor induction regimen comprised 50 μg of misoprostol administered 4 hourly for up to 3 doses in the first 24 hours. Participants assigned to regular assessment had vaginal examinations before each 4-hourly misoprostol dose with a view to amniotomy as soon as it was feasible. Participants in the restricted arm had vaginal examinations only if indicated. Primary outcomes were patient satisfaction with the birth process (using an 11-point visual numerical rating scale), induction to vaginal delivery interval, and vaginal delivery rate at 24 hours.
RESULTS: Data from 204 participants (101 regular, 103 restricted) were analyzed. The patient satisfaction score with the birth process was as follows (median [interquartile range]): 7 [6-9] vs 8 [6-10], P = .15. The interval of induction to vaginal delivery (mean ± standard deviation) was 24.3 ± 12.8 vs 31.1 ± 15.0 hours (P = .013). The vaginal delivery rate at 24 hours was 27.7% vs 20.4%; (relative risk [RR], 1.4; 95% confidence interval [CI], 0.8-2.3; P = .14) for the regular vs restricted arms, respectively. The cesarean delivery rate was 50% vs 43% (RR, 1.1; 95% CI, 0.9-1.5; P = .36). When assessed after delivery, participants' fidelity to their assigned vaginal examination schedule in a future labor induction was 45% vs 88% (RR, 0.5; 95% CI, 0.4-0.7; P < .001), and they would recommend their assigned schedule to a friend (47% vs 87%; RR, 0.6; 95% CI, 0.5-0.7; P < .001) in the regular compared with the restricted arms, respectively.
CONCLUSION: Despite a shorter induction to vaginal delivery interval with regular vaginal examination and a similar vaginal delivery rate at 24 hours and birth process satisfaction score, women expressed a higher preference for the restricted examination schedule and were more likely to recommend such a schedule to a friend.
OBJECTIVES: To compare the effectiveness, acceptability, and consequences of routine vaginal examinations compared with other methods, or different timings, to assess labour progress at term.
SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth Trials Register (which includes trials from CENTRAL, MEDLINE, Embase, CINAHL, and conference proceedings) and ClinicalTrials.gov (28 February 2021). We also searched the reference lists of retrieved studies.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) of vaginal examinations compared with other methods of assessing labour progress and studies assessing different timings of vaginal examinations. Quasi-RCTs and cluster-RCTs were eligible for inclusion. We excluded cross-over trials and conference abstracts.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed all studies identified by the search for inclusion in the review. Four review authors independently extracted data. Two review authors assessed risk of bias and certainty of the evidence using GRADE.
MAIN RESULTS: We included four studies that randomised a total of 755 women, with data analysed for 744 women and their babies. Interventions used to assess labour progress were routine vaginal examinations, routine ultrasound assessments, routine rectal examinations, routine vaginal examinations at different frequencies, and vaginal examinations as indicated. We were unable to conduct meta-analysis as there was only one study for each comparison. All studies were at high risk of performance bias due to difficulties with blinding. We assessed two studies as high risk of bias and two as low or unclear risk of bias for other domains. The overall certainty of the evidence assessed using GRADE was low or very low. Routine vaginal examinations versus routine ultrasound to assess labour progress (one study, 83 women and babies) Study in Turkey involving multiparous women with spontaneous onset of labour. Routine vaginal examinations may result in a slight increase in pain compared to routine ultrasound (mean difference -1.29, 95% confidence interval (CI) -2.10 to -0.48; one study, 83 women, low certainty evidence) (pain measured using a visual analogue scale (VAS) in reverse: zero indicating 'worst pain', 10 indicating no pain). The study did not assess our other primary outcomes: positive birth experience; augmentation of labour; spontaneous vaginal birth; chorioamnionitis; neonatal infection; admission to neonatal intensive care unit (NICU). Routine vaginal examinations versus routine rectal examinations to assess labour progress (one study, 307 women and babies) Study in Ireland involving women in labour at term. We assessed the certainty of the evidence as very low. Compared with routine rectal examinations, routine vaginal examinations may have little or no effect on: augmentation of labour (risk ratio (RR) 1.03, 95% CI 0.63 to 1.68; one study, 307 women); and spontaneous vaginal birth (RR 0.98, 95% CI 0.90 to 1.06; one study, 307 women). We found insufficient data to fully assess: neonatal infections (RR 0.33, 95% CI 0.01 to 8.07; one study, 307 babies); and admission to NICU (RR 1.32, 95% CI 0.47 to 3.73; one study, 307 babies). The study did not assess our other primary outcomes: positive birth experience; chorioamnionitis; maternal pain. Routine four-hourly vaginal examinations versus routine two-hourly examinations (one study, 150 women and babies) UK study involving primiparous women in labour at term. We assessed the certainty of the evidence as very low. Compared with routine two-hourly vaginal examinations, routine four-hourly vaginal examinations may have little or no effect, with data compatible with both benefit and harm, on: augmentation of labour (RR 0.97, 95% CI 0.60 to 1.57; one study, 109 women); and spontaneous vaginal birth (RR 1.02, 95% CI 0.83 to 1.26; one study, 150 women). The study did not assess our other primary outcomes: positive birth experience; chorioamnionitis; neonatal infection; admission to NICU; maternal pain. Routine vaginal examinations versus vaginal examinations as indicated (one study, 204 women and babies) Study in Malaysia involving primiparous women being induced at term. We assessed the certainty of the evidence as low. Compared with vaginal examinations as indicated, routine four-hourly vaginal examinations may result in more women having their labour augmented (RR 2.55, 95% CI 1.03 to 6.31; one study, 204 women). There may be little or no effect on: • spontaneous vaginal birth (RR 1.08, 95% CI 0.73 to 1.59; one study, 204 women); • chorioamnionitis (RR 3.06, 95% CI 0.13 to 74.21; one study, 204 women); • neonatal infection (RR 4.08, 95% CI 0.46 to 35.87; one study, 204 babies); • admission to NICU (RR 2.04, 95% CI 0.63 to 6.56; one study, 204 babies). The study did not assess our other primary outcomes of positive birth experience or maternal pain.
AUTHORS' CONCLUSIONS: Based on these findings, we cannot be certain which method is most effective or acceptable for assessing labour progress. Further large-scale RCT trials are required. These should include essential clinical and experiential outcomes. This may be facilitated through the development of a tool to measure positive birth experiences. Data from qualitative studies are also needed to fully assess whether methods to evaluate labour progress meet women's needs for a safe and positive labour and birth, and if not, to develop an approach that does.
OBJECTIVE: In this study we use transperineal ultrasound to identify how many women will achieve a normal vaginal delivery without substantial damage to the levator ani or anal sphincter muscles, and to create a model to predict patient characteristics associated with successful atraumatic normal vaginal delivery.
STUDY DESIGN: This is a retrospective, secondary analysis of data sets gathered in the context of an interventional perinatal imaging study. A total of 660 primiparas, carrying an uncomplicated singleton pregnancy, underwent an antepartum and postpartum interview, vaginal exam (Pelvic Organ Prolapse Quantification), and 4-dimensional translabial ultrasound. Ultrasound data were analyzed for levator trauma and/or overdistention and residual sphincter defects. Postprocessing analysis of ultrasound volumes was performed blinded against clinical data and analyzed against obstetric data retrieved from the local maternity database. Levator avulsion was diagnosed if the muscle insertion at the inferior pubic ramus at the plane of minimal hiatal dimensions and within 5 mm above this plane on tomographic ultrasound imaging was abnormal, ie the muscle was disconnected from the inferior pubic ramus. Hiatal overdistensibility (microtrauma) was diagnosed if there was a peripartum increase in hiatal area on Valsalva by >20% with the resultant area ≥25 cm2. A sphincter defect was diagnosed if a gap of >30 degrees was seen in ≥4 of 6 tomographic ultrasound imaging slices bracketing the external anal sphincter. Two models were tested: a first model that defines severe pelvic floor trauma as either obstetric anal sphincter injury or levator avulsion, and a second, more conservative model, that also included microtrauma.
RESULTS: A total of 504/660 women (76%) returned for postpartum follow-up as described previously. In all, 21 patients were excluded due to inadequate data or intercurrent pregnancy, leaving 483 women for analysis. Model 1 defined nontraumatic vaginal delivery as excluding operative delivery, obstetric anal sphincter injuries, and sonographic evidence of levator avulsion or residual sphincter defect. Model 2 also excluded microtrauma. Of 483 women, 112 (23%) had a cesarean delivery, 103 (21%) had an operative vaginal delivery, and 17 (4%) had a third-/fourth-degree tear, leaving 251 women who could be said to have had a normal vaginal delivery. On ultrasound, in model 1, 27 women (6%) had an avulsion and 31 (6%) had a residual defect, leaving 193/483 (40%) who met the criteria for atraumatic normal vaginal delivery. In model 2, an additional 33 women (7%) had microtrauma, leaving only 160/483 (33%) women who met the criteria for atraumatic normal vaginal delivery. On multivariate analysis, younger age and earlier gestation at time of delivery remained highly significant as predictors of atraumatic normal vaginal delivery in both models, with increased hiatal area on Valsalva also significant in model 2 (all P ≤ .035).
CONCLUSION: The prevalence of significant pelvic floor trauma after vaginal child birth is much higher than generally assumed. Rates of obstetric anal sphincter injury are often underestimated and levator avulsion is not included as a consequence of vaginal birth in most obstetric text books. In this study less than half (33-40%) of primiparous women achieved an atraumatic normal vaginal delivery.