RESUMO
Background: We believe that physiotherapy with muscle training (MT) of the postpartum pelvic floor may lead to a change in the clinical management of patients with avulsion of the puborectal portion of the levator ani muscle (LAM). Our objective is to assess whether physiotherapy with MT of the postpartum pelvic floor in patients with LAM avulsion produces changes in pelvic floor morphology evaluated by 3/4D transperineal ultrasound. Methods: This parallel randomized controlled trial (RCT) included 97 primiparous patients. A study was conducted in three parts. In the first part (3 months postpartum), primiparous patients with LAM avulsion were recruited, and the levator hiatus and the LAM areas were measured using 3/4D transperineal ultrasound. In the second part (3 to 6 months postpartum), patients were randomized into two groups, with one undergoing rehabilitation (experimental group) and another without rehabilitation (control group). At the end of 6 months, a new transperineal ultrasound was performed. In the third part (9 months postpartum), the levator hiatus and LAM dimensions were analyzed again. The RCT was registered at ClinicalTrials.gov (NCT03686956). Project PI16/01387 funded by Instituto de Salud Carlos III (Spain) integrated in the national I+D+i 2013-2016 and cofounded by the European Union (ERDF/ESF, "Investing in your future"). Results: A total of 92 completed the study, including 46 patients in the experimental group and 46 in the control group. The experimental group had a greater LAM area at 6 months (9.2±1.9 vs. 7.6±2.1 cm2, P=0.008; 95% CI: 0.6-3.0) and 9 months after labor (9.4±2.7 vs. 7.6±2.0 cm2, P=0.012; 95% CI: 0.4-3.2), which was not observed at 3 months postpartum (8.3±1.6 vs. 7.5±2.3 cm2; P=0.183; 95% CI: 0.39-1.99). The levator hiatus area decreased more in the experimental group in almost all comparisons. The most significant change occurred from 3 to 6 months during the Valsalva maneuver (-3.92±5.12 vs. 0.45±3.06 cm2; P<0.005; 95% CI: 2.64-5.00). Conclusions: Women with a rehabilitated LAM through physiotherapy showed a significant reduction in the levator hiatus area during Valsalva while receiving in-person physical therapy (3 to 6 months after delivery). These differences did not persist once physical therapy was completed (6 to 9 months after delivery). Trial Registration: ClinicalTrials.gov identifier NCT03686956.
RESUMO
BACKGROUND: Complicated operative vaginal deliveries are associated with high neonatal morbidity and maternal trauma, especially if the procedure is unsuccessful and a cesarean delivery is needed. The decision to perform an operative vaginal delivery has traditionally been based on a subjective assessment by digital vaginal examination combined with the clinical expertise of the obstetrician. Currently there is no method for objectively quantifying the likelihood of successful delivery. Intrapartum ultrasound has been introduced in clinical practice to help predict the progression and final method of delivery. OBJECTIVE: The aim of this study was to compare predictive models for identifying complicated operative vaginal deliveries (vacuum or forceps) based on intrapartum transperineal ultrasound in nulliparous women. STUDY DESIGN: We performed a prospective cohort study in nulliparous women at term with singleton pregnancies and full dilatation who underwent intrapartum transperineal ultrasound evaluation prior to operative vaginal delivery. Managing obstetricians were blinded to the ultrasound data. Intrapartum transperineal ultrasound (angle of progression, progression distance, and midline angle) was performed immediately before instrument application, both at rest and concurrently with pushing. Intrapartum evaluation of fetal biometric parameters (estimated fetal weight, head circumference, and biparietal diameter) was also carried out. An operative vaginal delivery was classified as complicated when 1 or more of the following complications occurred: ≥3 tractions needed; third- to fourth-degree perineal tear; severe bleeding during episiotomy repair (decrease of ≥2.5 g/dL in the hemoglobin level); or significant traumatic neonatal lesion (subdural-intracerebral hemorrhage, epicranial subaponeurotic hemorrhage, skeletal injuries, injuries to spine and spinal cord, or peripheral and cranial nerve injuries). Six predictive models were evaluated (information available in Table 2). RESULTS: We recruited 84 nulliparous patients, of whom 5 were excluded because of the difficulty of adequately evaluating the biparietal diameter and head circumference. A total of 79 nulliparous patients were studied (47 vacuum deliveries, 32 forceps deliveries) with 13 cases in the occiput-posterior position. We identified 31 cases of complicated operative vaginal deliveries (19 vacuum deliveries and 12 forceps deliveries). No differences were identified in obstetric, neonatal, or intrapartum characteristics between the 2 study groups (operative uncomplicated vaginal delivery vs operative complicated vaginal delivery), with the following exceptions: estimated fetal weight (3243 ± 425 g vs 3565 ± 330 g; P = .001), biparietal diameter (93.2 ± 2.1 vs 95.2 ± 2.3 mm; P = .001), head circumference (336 ± 12 vs 348 ± 6.4 mm; P = .001), sex (female 62.5% vs 29.0%; P = .010), newborn weight (3258 ± 472 g vs 3499 ± 383 g; P = .027), and number of tractions (median, interquartile range) (1 [1-2] vs 4 [3-5]; P < .0005). To predict complicated operative deliveries, all 6 of the studied models presented an area under the receiver-operating characteristics curve between 0.863 and 0.876 (95% confidence intervals, 0.775-0.950 and 0.790-0.963; P < .0005). The results of the study met the criteria of interpretability and parsimony (simplicity), allowing us to identify a binary logistic regression model based on the angle of progression and head circumference; this model has an area under the receiver-operating characteristics curve of 0.876 (95% confidence interval, 0.790-0.963; P < .0005) and a calibration slope B of 0.984 (95% confidence interval, 0.0.726-1.243; P < .0005). CONCLUSION: The combination of the angle of progression and the head circumference can predict 87% of complicated operative vaginal deliveries and can be performed in the delivery room.
