Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study.

INTRODUCTION: Though interest is growing for trials comparing planned delivery mode (vaginal delivery [VD]; cesarean section [CS]) in low-risk nulliparous women, appropriate study design is unclear. Our objective was to assess feasibility of three designs (preference trial [PCT], randomized controlled trial [RCT], partially randomized patient preference trial [PRPPT]) for a trial comparing planned delivery mode in low-risk women. METHODS: A cross-sectional survey of low-risk, nulliparous pregnant women (N = 416) and healthcare providers (N = 168) providing prenatal care and/or labor/delivery services was conducted in Argentina (2 public, 2 private hospitals). Proportion of pregnant women and providers willing to participate in each design and reasons for not participating were determined. RESULTS: Few women (< 15%) or professionals (33.3%) would participate in an RCT, though more would participate in PCTs (88% women; 65.9% professionals) or PRPPTs (44.4% public, 63.4% private sector women; 44.0% professionals). However, most women would choose vaginal delivery in the PCT and PRPPT (> 85%). Believing randomization unacceptable (RCT, PRPPT) and desiring choice of delivery mode (RCT) were women's reasons for not participating. For providers, commonly cited reasons for not participating included unacceptability of performing CS without medical indication, difficulty obtaining informed consent, discomfort enrolling patients (all designs), and violating women's right to choose (RCT). CONCLUSIONS FOR PRACTICE: Important limitations were found for each trial design evaluated. The necessity of stronger evidence regarding delivery mode in low-risk women suggests consideration of additional designs, such as a rigorously designed cohort study or an RCT within an obstetric population with equivocal CS indications.

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

BACKGROUND: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. RESULTS: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. CONCLUSIONS: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. TRIAL REGISTRATION: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol.

BACKGROUND: Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings. METHODS/DESIGN: This will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate). TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR). Identifier: ACTRN12613000141741.

Placenta accreta spectrum: a hysterectomy can be prevented in almost 80% of cases using a resective-reconstructive technique.

OBJECTIVE: To describe the use of surgical repair (One-step resective-conservative surgery) in all cases of placenta accreta spectrum. STUDY DESIGN: Multicentre retrospective case series from tertiary referral hospitals in Argentina. A total of 452 patients were accepted from 12 hospitals presenting suspicion of invasive placenta by auxiliary methods (ultrasound, Doppler and MRI). At the time of the surgery, placenta accreta spectrum was classified according to invasion topography (specific blood supply) and local features (proximity to other structures, adhesion process, and multiple anastomotic blood vessels). Type 1: upper posterior bladder; type 2: parametrial; type 3: low posterior bladder; and type 4: low posterior bladder and fibrosis. After the ligature of newly formed vessels between the uterus and pelvic organs, the fetus was delivered through an upper segmental hysterotomy. Hemostasis was achieved by selective ligature of vesical-uterine and colpo-uterine vessels. Then, the invaded myometrium and the entire placenta were removed totally in bloc and until detected healthy tissue in both edges, to guarantee the most physiological hysterotomy in the uterine segment. The uterus was closed with a polyglactin suture, double-layer technique. The main outcome measurements were the uterine conservation, the blood loss and other complications classified according to intrasurgical classification. RESULTS: From 452 accepted patients, 326 patients had a confirmed diagnosis of placenta accreta spectrum by histology analysis and surgical-clinical findings. In 126 cases, placenta accreta spectrum was excluded used the same diagnostic criteria (Type 0 or false positive PAS). They were identified 248 cases as type 1, 44 as type 2, 23 as type 3 and 11 as type 4. Uterine conservation was possible in the 81% of type 1 invasion with 500 mL of blood loss (interquartile range, IQR = Q3 - Q1). The modified Pfannenstiel was the most commonly used incision, while midline incision was chosen in all emergencies or in patients with a previous midline incision. Hysterotomy made in the upper part of the uterine segment presented normally attached placentas and not accreta. Selective vessel ligature, also named custom-made hemostasis method (CMHM) was effective at stopping or preventing bleeding associated with PAS. The entire placenta and the invaded area are removed in block, to guarantee to perform the uterine repair with healthy tissue and to avoid a recurrence in the subsequent cesarean. The uterine-ovary artery axis is never occluded or obliterate to guarantee the uterine-endometrial and ovary blood supply as before surgery. No significant differences existed according to the population; however, the presence of total occlusive placenta previa was more frequent in types 3 and 4, which were also associated with older mothers and age-related collagen changes. Lateral and lower segment invasions (types 2 and 3) were most commonly associated with previous terminations of pregnancy, curettage, and manual removal of the placenta. Blood loss and technical difficulty were clearly associated to the invaded area, while invasion degree was a poor marker to predicting bleeding or complications in all locations Uterine conservation was possible in 202/248 (81.5%) of type 1, 21/44 (47.7%) of type 2, 5/23 (21.8%) of type 3 and 0/11 (0%) of type four cases. Type 0 (false positive) were excluded of statistical analysis, and the uterus was preserved in 100% of cases. In a separate report, we will describe the maternal and fetal outcomes as well as 204 subsequent pregnancies after the use of one-step resective reconstructive technique. CONCLUSIONS: Using the resective-reconstructive approach (one-step conservative surgery) to the management of invasive placenta, the uterus can be preserved with minimal morbidity and reduced blood loss in almost 80% of cases. Précis preventing hysterectomy in 80% of placenta accreta spectrum.

Neonatal outcome after conservative-reconstructive surgery for placenta accreta spectrum disorders.

AIM: To report the neonatal outcome after conservative-reconstructive surgery for placenta accreta spectrum (PAS) disorders. MATERIALS AND METHODS: Inclusion criteria were women undergoing conservative-reconstructive surgery for PAS. The outcomes explored were: 5 min Apgar score, birth weight, and need for ventilatory support (RS1 supplementary oxygen, RS2 nasal positive pressure ventilation, or RS3 mechanical ventilatory assistance). Descriptive statistics (means and standard deviations for quantitative and percentage and interquartile range for quantitative variables) were sued to report the data. RESULTS: 84% of women with PAS type 1 were delivered between 35 and 37 weeks of gestation. There was only one case of small for gestational age (SGA) newborn 81% of the newborns required admission to the NICU and 11% respiratory support of those pregnancies complicated by PAS type 2, 59% were delivered between 35 and 36.6 weeks. Neonatal birth weight was consistent with gestational age at birth for all the included cases, and there was no SGA newborn in this group. 84% of the newborns required admission to the NICU, while 21% respiratory support. All women with PAS type 3 were delivered between 30 and 33 weeks of gestation. Although all newborns were admitted to NICU and 73% required ventilatory support, there was no SGA case. Pregnancies complicated by PAS type 4 completed their pregnancy between weeks 35 and 37. There was no case affected by SGA; although all newborns were admitted to NICU, none required ventilatory support. CONCLUSIONS: Conservative surgery in pregnancies complicated by PAS does not seem to increase the risk of adverse neonatal outcomes. Early gestational age at birth and invasion in the inferior third of the lower uterine segment is associated with an increased incidence of neonatal complications, likely due to the earlier gestational age at delivery for these pregnancies.

Clinical implementation of a cervical cancer screening program via co-testing at a university hospital.

The Human Papillomavirus (HPV) test is a crucial technology for cervical cancer prevention because it enables programs to identify women with high-risk HPV infection who are at risk of developing cervical cancer. Current U.S. Preventive Services Task Force recommendations include cervical cancer screening every three years with cervical cytology alone or every five years with either high-risk HPV testing alone or high-risk HPV testing combined with cytology (co-testing). In Argentina, 7,548 new cervical cancer cases are diagnosed each year with 3,932 deaths attributed to this cause. Our study aims to show the clinical implementation of a cervical cancer screening program by concurrent HPV testing and cervical cytology (co-testing); and to evaluate the possible cervical cancer screening scenarios for Latin America, focusing on their performance and average cost. A cervical cancer screening five year program via co-testing algorithm (Hybrid-2-Capture/cytology) was performed on women aged 30-65 years old at a university hospital. Statistical analysis included a multinomial logistic regression, and two cancer screening classification alternatives were tested (cytology-reflex and HPV-reflex). A total of 2,273 women were included, 91.11% of the participants were double-negative, 2.55% double-positive, 5.90% positive-Hybrid-2-Capture-/negative-cytology, and 0.44% negative-Hybrid-2-Capture/positive-cytology. A thorough follow-up was performed in the positive-Hybrid-2-Capture group. Despite our efforts, 21 (10.93%) were lost, mainly because of changes on their health insurance coverage which excluded them from our screening algorithm. Of the 171 women with positive-Hybrid-2-Capture results and follow-up, 68 (39.77%) cleared the virus infection, 64 (37.43%) showed viral persistence, and 39 (22.81%) were adequately treated after detection via colposcopy/biopsy of histological HSIL (High-Grade Squamous Intraepithelial Lesion). The prevalence of high-risk HPV in this population was 192 women (8.45%), with HSIL histology detection rates of 17 per 1,000 screened women. A multinomial logistic regression analysis was performed over the women with positive-Hybrid-2-Capture considering the follow up (clearance, persistence and HSIL) as dependent variable, and the cytology test results (positive- or negative-cytology and Atypical Squamous Cells of Undetermined Significance, ASC-US) as independent variable. The model supported a direct association between cytology test results and follow up: negative-cytology/clearance, ASC-US/persistence, and positive-cytology/HSIL with the following probabilities of occurrence for these pairs 0.5, 0.647 and 0.647, respectively. Cytology could be considered a prognostic-factor in women with a positive-Hybrid-2-Capture. These findings suggest that the introduction of co-testing could diminish the burden of cervical cancer in low-and middle-income-countries, acting as a tool against inequity in healthcare.

Conservative approach in heavy postpartum hemorrhage associated with coagulopathy.

The application of external uterine elastic bandage is a new approach to control serious postpartum hemorrhage. This was applied in 10 consecutive patients with severe postpartum hemorrhage. After circulatory stabilization by external aortic compression, laparotomy and identification of the source of bleeding, compression sutures were applied and intrauterine fibrin glue was administered. Immediately thereafter, external uterine elastic bandage was wrapped around the uterus to compress it and stop the bleeding. After hemostasis had persisted for some time, the bandage was removed, and uterus and abdomen were then closed. Application of external uterine elastic bandage resulted in hemostasis within 45 minutes after aortic compression. Hysteroscopy 6 months after the procedure showed no signs of uterine ischemia or endometrial adhesions. In conclusion, external elastic uterine bandage is a simple tool that seems to improve hemostasis and prevent hysterectomy in heavy postpartum hemorrhage.

Systematic review on near miss cases of placenta accreta spectrum disorders: correlation with invasion topography, prenatal imaging, and surgical outcome.

Purpose of the article: Placental accreta spectrum (PAS) is the most dangerous iatrogenic complication of cesarean potentially leading to massive intra-partum haemorrhage and death. Despite this, identification of near miss cases of PAS has not been consistently reported in the published literature. The aim of this systematic review was to explore prenatal and surgical characteristics of near miss cases of PAS disorders.Materials and methods: Medline, Embase, CINAHL, SciELO, and Cochrane databases were searched. Only studies including near miss cases of PAS disorders in which a detailed description of the clinical course, severity of placental invasion, role of prenatal imaging, and surgical management were considered eligible for the inclusion in the present systematic review. Random-effect meta-analyses of proportions were used to pool the data.Results: Thirty-four studies were included in the systematic review. The incidence of placenta accreta, increta, and percreta in near miss cases of PAS disorders was 0% (95% CI 0-24.6), 17.3% (95% CI 8.4-28.6) and 82.7% (95% CI 71.4-91.6). S1 invasion, defined as invasion in the upper posterior bladder wall was present in none of the near miss cases of PAS while all included cases showed S2 invasion. Prenatal imaging, either ultrasound or magnetic resonance imaging, detected invasive placenta in 54.4% (95% CI 41.0-67.5). Clinical symptoms occurred in 65.3% (95% CI 52.1-77.4) of near miss cases of PAS before surgery, while the corresponding figures for symptoms occurring during and after surgery were 65.5% (95% CI 52.2-77.5) and 50.0% (95% CI 36.5-63.5) of cases, respectively. Invasion in the inferior part of the lower uterine segment, posterior bladder and parametria was associated with a high risk of morbidity.Conclusion: Near miss cases of PAS are commonly associated with posterior bladder or parametrial invasion and placenta percreta. Further studies are needed in order to identify women affected by PAS disorders at high risk of surgical complications.