Intramyometrial and intravenous oxytocin compared to intravenous carbetocin for prevention of postpartum hemorrhage in elective cesarean section-A quasi-randomized controlled phase IV non-inferiority interventional trial.

INTRODUCTION: Our objective was to assess non-inferiority of the unique approach used in our institution of combined 10 IU IM (intramyometrial) and 10 IU IV (intravenous) oxytocin to carbetocin IV in preventing severe postpartum blood loss in elective cesarean sections. The design was a prospective controlled phase IV non-inferiority interventional trial. The setting was a tertiary center at University Hospital, Zurich, Switzerland. MATERIAL AND METHODS: The population consisted of 550 women undergoing elective cesarean section after 36 completed weeks of gestation at low risk for postpartum hemorrhage (PPH). Participants were assigned to either combined oxytocin regimen (10 IU IM and 10 IU IV) or carbetocin (100 µg IV). Non-inferiority for oxytocin for severe PPH was assessed with a 0.05 margin using the Newcombe-Wilson score method. The main outcome measures were severe postpartum blood loss defined as delta hemoglobin (∆Hb, Hb prepartum-Hb postpartum) ≥30 g/L. RESULTS: Non-inferiority of combined oxytocin (IM/IV) in preventing severe postpartum blood loss was not shown (17 women in the oxytocin group vs. 7 in the carbetocin group). The number needed to treat when using carbetocin was 28. The risk difference for ∆Hb ≥30 g/L was 0.04 (oxytocin 0.06 vs. 0.03), 95% confidence interval (CI) (0.00-0.08). No significant difference was observed for ∆Hb (median 12 [IQR 7.0-19.0] vs. 11 [5.0-17.0], p = 0.07), estimated blood loss (median 500 [IQR 400-600] vs. 500 [400-575], p = 0.38), or the PPH rate defined as estimated blood loss ≥1000 mL (12[4.5] vs. 5 [2.0], risk difference 0.03, 95% CI (-0.01 to 0.06), p = 0.16). More additional uterotonics were administered in the oxytocin group compared to the carbetocin group (15.2% vs. 5.9%, p = 0.001). Total case costs were non-significantly different in the oxytocin group (US $ 10 146 vs. 9621, mean difference 471.4, CI (-476.5 to 1419.3), p = 0.33). CONCLUSIONS: Combined (IM/IV) oxytocin is not non-inferior to carbetocin regarding severe postpartum blood loss defined as postpartum Hb decrease ≥30 g/L in elective cesarean sections. We recommend carbetocin for use in clinical practice for elective cesarean sections.

Evaluation of two rapid commercial assays for detection of Streptococcus agalactiae from vaginal samples.

INTRODUCTION: Streptococcus agalactiae, also known as group B streptococci (GBS), is associated with invasive infections in neonates. Identification of GBS vaginal colonization in pregnant women before delivery is essential for treatment with antibiotics to prevent intrapartum vertical transmission to the newborn. This study was designed to evaluate applicability of two rapid real-time PCRs in comparison to standard culture identification. MATERIAL AND METHODS: We compared the Xpert GBS assay, hereafter referred to as Xpert, and GenomEra GBS PCR, hereafter referred to as GenomEra. The standard culture identification consisted of two different agar plates as well as an enrichment broth. RESULTS: We analyzed vaginal samples of 260 pregnant women; 42 samples were tested GBS-positive by using standard culture as a gold standard, 30 by Xpert, and 37 by GenomEra. Xpert and GenomEra assays performed with sensitivities of 71.4% and 88.1% as well as specificities of 98.6% and 99.1%, respectively. Twelve vaginal samples were false-negative by Xpert and five samples by GenomEra. Interestingly, three negative Xpert results of standard culture-positive samples exhibited high Ct-values indicating the presence of GBS. If higher Ct-values are taken into consideration, the sensitivity of Xpert increases up to 78.6%. Moreover, only three Xpert PCRs had to be repeated, whereas two Genomera were invalid even after repetition and further 15 GenomEra PCRs were repeated because of borderline results or inhibition of the PCR test. CONCLUSIONS: In this study, GenomEra assay performed with a higher sensitivity than the Xpert PCR. On the other hand, the Xpert assay needs less hands-on-time for a sample preparation and requires approximately four-fold less repetitions as compared to the GenomEra assay. This robust performance of the Xpert assay make it applicable as a rapid intrapartum point-of-care test, although a higher sensitivity would be desirable. Therefore, culture in the 35-37 week of gestation remains the gold standard to detect vaginal colonization.

Second systolic peak in fetal middle cerebral artery Doppler after intrauterine transfusion.

OBJECTIVE: To evaluate functional relationship between fetal circulatory response to intrauterine transfusion (IUT) as a circulatory challenge and appearance of second systolic peak (P2) in middle cerebral artery (MCA) based on hemodynamic principles. METHODS: According to the concept of pulse wave (PW) propagation and reflection in adults, PWs arrive twice at cerebral circulation, as primary wave caused by left ventricle ejection and secondary after reflection in peripheral arteries. Thus adults show a biphasic contour of systolic blood flow in cerebral arteries. Similar waveforms may appear in fetal MCA-Doppler, as a response to IUT as a circulatory challenge. This is a proof-of-principle study, applying classical hemodynamic principles to fetal circulation. Accordingly, appearance of MCA-P2 may indicate vasoconstriction with increased PW reflection and timing of P2(Δt) should agree with the additional PW travel time down to reflection and return (Tr). To test this agreement, we searched our database for IUTs performed for severe fetal anemia, and compared Δt, obtained by Doppler, with Tr, obtained by hemodynamic calculation using human fetal data. Level of agreement was assessed using Bland-Altman-Plots. RESULTS: We identified 21 fetuses with adequate Doppler quality for Δt evaluation. In four cases (19%) MCA-P2 was observed before the intervention, and in 17 interventions (81%) thereafter; a highly significant association between IUT and P2 appearance (p < 0.001). In these 17 interventions good agreement of P2 timing was found between Doppler assessment: Δt = 80 ± 8 ms, and hemodynamic calculation: Tr = 76 ± 4 ms. CONCLUSION: P2 appearance in fetal MCA-Doppler seems to indicate PW reflection due to increased vasoconstriction after IUT. Thus hemodynamic considerations might enable Doppler monitoring of fetal vasoconstriction.

M-Sign in Middle Cerebral Artery Doppler Waveforms: A Sign of Fetal Vasoconstriction Before and After Open Fetal Spina Bifida Repair.

BACKGROUND: Increased pulse wave reflection in the fetal arterial system, illustrated by a second systolic peak (M-sign) in middle cerebral artery (MCA) Doppler waveforms, allows interpretation of fetal systemic vasoconstriction. Little is known about fetal vascular regulation during fetal spina bifida (fSB) repair. Therefore, the aim of this study was to analyze MCA-Doppler waveform changes before, during, and after fSB repair. PATIENTS AND METHODS: 31 pregnant women who underwent fSB repair were included. Fetal MCA-Doppler waveforms were prospectively analyzed before, during and after fSB repair, and categorized as follows: normal systolic downslope, systolic shoulder, second systolic peak (M-sign), and concave systolic downslope. These MCA waveforms were related to maternal and fetal characteristics, to anesthetic medication, and to umbilical artery (UA) waveforms. RESULTS: Before fSB repair, all fetuses repeatedly presented M-signs. After initiation of desflurane for general anesthesia, systolic shoulder and the M-sign vanished in 24/31 (78%) fetuses and 19/31 (61%) showed transient UA ARED flow. A significant association between these two Doppler findings was found (p=0.007). After fSB repair, signs of increased pulse wave reflection reappeared but resolved over time (23 days ± 20, SD) in all fetuses. CONCLUSION: Both fSB and intrauterine repair influence fetal vascular regulation. This phenomenon can be illustrated by MCA-Doppler waveforms. While anesthetic agents transiently eliminated M-signs and often provoked a UA ARED flow, fSB repair finally led to normalization of MCA-Doppler waveforms indicating return to normal fetal vascular regulation.

Prenatal Spina Bifida Repair: Defendable Trespassing of MOMS Criteria Results in Commendable Personalized Medicine.

INTRODUCTION: We hypothesize that after publication of the quintessence of the MOMS trial, eligibility criteria for prenatal spina bifida (SB) repair may be modified if a tenable argumentation underlies this decision. METHODS: Our first 154 fetal surgery patients were analyzed with particular focus on how many, which, and why the original eligibility criteria, set forth by the MOMS Trial Protocol, were disobeyed, and what the eventually detectable, negative and positive impacts of these deviations on outcomes were. RESULTS: A total of 152 patients (2 missing consent) were included (100%). In 69 patients (45.4%), a total of 89 eligibility criteria were disobeyed. In 54 (35.6%) cases, the following maternal criteria were concerned: gestational age at operation of >25+6 weeks in 17 (11.2%), uterine pathologies in 13 (8.6%) women, preoperative BMI ≥35 kg/m2 in 12 (7.9%), previous hysterotomy in 7 (4.6%), previous prematurity in 3 (2%), HIV/hepatitis B in 2 (1.3%), psychosocial issues in 2 (1.3%), and placenta praevia in 1 (0.7%). In 32 (21.1%) cases, fetal criteria were disobeyed 34 times: Fetal anomaly unrelated to SB in 19 (12.5%), no/minimal evidence of hindbrain herniation in 13 (8.6%), and severe kyphosis in 2 (1.3%). We could not identify cases where non-observation of criteria led to clear-cut maternal and/or fetal disadvantages. CONCLUSION: This study shows that MOMS trial eligibility criteria for prenatal SB repair should be modified or even abandoned with adequate medical and ethical argumentation, and with written parental informed consent after non-directive, full disclosure counseling. This clear-cut change of paradigm is a necessity as it leads toward personalized medicine, allowing more fetuses to benefit from fetal surgery than would have benefitted with the former, published, MOMS criteria in place.

Success Rate and Long-Term Effects of Embolization of Pelvic Arteries for the Treatment of Postpartum Hemorrhage.

Introduction: Postpartum hemorrhage (PPH) is the leading cause of peripartal maternal mortality and accounts for 25% of all maternal deaths worldwide. The most common reasons of PPH are uterine atony, retained placenta, or placenta accreta spectrum. Treatment of PPH depends on the etiology and corresponds to a stepwise approach, which follows the German, Austrian and Swiss guideline for the diagnosis and therapy of PPH in Switzerland. In severe ongoing PPH, hysterectomy has been the ultima ratio for many decades. Nowadays, interventional embolization of the pelvic arteries (PAE) has become a popular alternative. Besides being a highly effective minimally invasive method, PAE avoids hysterectomy with consecutively reduced morbidity and mortality. However, data on the long-term effects of PAE on fertility and menstrual cycle are scarce. Methods: We performed a monocentric study consisting of a retro- and a prospective part including all women who had undergone a PAE between 2012 and 2016 at University Hospital Zurich. Descriptive characteristics of patients and efficacy of PAE defined as cessation of bleeding were analyzed retrospectively. In the prospective part, all patients were contacted for a follow-up questionnaire regarding menstruation and fertility after embolization. Results: Twenty patients with PAE were evaluated. Our data showed a success rate of PAE in 95% of patients with PPH; only 1 patient needed a second, then successful, PAE. No patient needed a hysterectomy or any other surgical intervention. In our study, an association between mode of delivery and identified etiology of PPH is observed. After spontaneous delivery (n = 6), the main reason of severe PPH was retained placenta (n = 4), while after cesarean section (n = 14), uterine atony was identified in most cases (n = 8). Regarding menstruation after embolization, all women reported regular menstruation after the breastfeeding period (100%). The majority reported a regular pattern with a shorter or similar duration (73%) and lower or similar intensity (64%). Dysmenorrhea decreased in 67% of patients. Four patients planned another pregnancy, of whom only one had become pregnant with assisted reproductive technology and ended up in a miscarriage. Discussion: Our study confirms the efficacy of PAE in PPH, thus obviating complex surgical interventions and associated morbidity. The success of PAE does not depend on the primary cause of PPH. Our results may encourage the prompt decision to perform PAE in the management of severe PPH in case of failure of conservative management and help physicians in the post-interventional counseling regarding menstruation patterns and fertility.

The Impact of Prepartum Platelet Count on Postpartum Blood Loss and Its Association with Coagulation Factor XIII Activity.

Background: Postpartum hemorrhage is a leading cause of maternal morbidity and mortality worldwide. Contradictory information exists regarding the relevance of prepartum platelet count on postpartum hemorrhage. We have shown prepartum coagulation factor XIII to be associated with postpartum blood loss; however, little is known about the association of platelet count with factor XIII activity. Our objectives were, first, to evaluate the impact of prepartum platelet count on measured postpartum blood loss in the context of prepartum measurements of coagulation factors I, II, and XIII and, second, to evaluate the association of platelet count with coagulation factor XIII, both pre- and postpartum. Material and Methods: This is a secondary analysis of a prospective cohort study (PPH 1,300 study) which analyzed the impact of prepartum blood coagulation factors on postpartum blood loss in 1,300 women. Blood loss was quantified using a validated technique. The impact of prepartum platelet count on measured blood loss was assessed by continuous outcome logistic regression; the association of platelet count with factor XIII activity by Spearman rank correlation. Results: Prepartum platelet count was significantly associated with measured postpartum blood loss: every one unit (G/L) increase in prepartum thrombocytes was associated with an odds ratio of 1.002 (95% confidence interval, 1.001-1.004, p = 0.005) to keep blood loss below any given cut-off level. This means that the probability of postpartum hemorrhage decreases with increasing prepartum platelet levels. Moreover, a significant association of platelet count with factor XIII activity was shown (Spearman rank correlation coefficient for prepartum values 0.228, p < 0.001, and for postpartum values 0.293, p < 0.001). Discussion/Conclusion: The significant association of prepartum platelet count and postpartum blood loss as well as the association of platelet count with blood coagulation factor XIII activity support the likely role of platelets in preventing postpartum hemorrhage and support the new guidelines for the treatment of postpartum hemorrhage in Germany, Austria, and Switzerland, which calls for optimizing platelet counts peripartally in case of postpartum hemorrhage. A possible effect of platelets on the level of circulating factor XIII cannot be ruled out and should prompt further investigation.

The evolution of levator ani muscle trauma over the first 9 months after vaginal birth.

INTRODUCTION AND HYPOTHESIS: The objective was to investigate the evolution of levator ani muscle (LAM) trauma over the first 9 months after birth and to evaluate their agreement between different assessment periods. METHODS: From March 2017 to April 2019 we prospectively evaluated LAM states (intact, hematoma, partial or complete avulsion) of primiparous women after vaginal birth by using 4D translabial ultrasound (TLUS) at three different assessment periods. All women were examined 1-4 days (A1) and 6-10 weeks (A2) postpartum, and women with a trauma additionally 6-9 months postpartum (A3). Cohen's Kappa analysis was performed to evaluate the test agreement between the assessment periods. RESULTS: Thirty-two percent of the women at A1 had a LAM trauma and 24% at A2. The higher number of LAM injuries at A1 can be explained by hematomas (14%), of which 51% spontaneously resolved at A2, 35% revealed themselves as partial, and 12% as complete avulsions. At A3, we observed anatomical improvement from complete to partial avulsions (23%) and few partial avulsions changed into an intact LAM (3%); none of the complete avulsions changed into an intact LAM. The agreement of 4D TLUS between A1 and A2 was moderate to good (0.64 for the right-sided LAM/0.60 for the left-sided LAM) and between A2 and A3 good to very good (0.76 right-sided/0.84 left-sided). CONCLUSIONS: Levator ani muscle trauma can reliably be diagnosed during all assessment periods. However, the agreement between A1 and A2 was only moderate to good. This can be explained by hematomas inside the LAM that were only observed early postpartum. We observed some anatomical improvement at A3, but no complete avulsion improved to an intact LAM.

2D pelvic floor ultrasound imaging in identifying levator ani muscle trauma agrees highly with 4D ultrasound imaging.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the agreement between 2D and 4D translabial ultrasound (TLUS) technique in showing levator ani muscle (LAM) states after vaginal birth. METHODS: In a prospective observational cohort study between March 2017 and April 2019 we evaluated LAM states (intact, hematoma, partial, complete avulsion) of primiparous women having given birth vaginally with singletons in vertex presentation ≥ 36+0 gestational weeks by using 2D and 4D TLUS within 1-4 days postpartum (assessment A1) and again 6-10 weeks postpartum (assessment A2). Cohen's Kappa analysis was performed for each side separately to evaluate the test agreement between the two ultrasound techniques at every assessment period. RESULTS: A total of 224 women participated at A1 and 213 at A2. The agreement between the two ultrasound techniques was good to very good at A1 (Cohen`s kappa right-sided 0.78, left-sided 0.82) and very good at A2 (Cohen`s kappa both sides 0.88). The agreement was best when assessing an intact LAM or a complete avulsion (Cohen`s kappa between 0.78-0.92 for complete avulsions). CONCLUSIONS: The comparison between 2D and 4D TLUS showed a good to very good agreement in LAM trauma immediately after birth as well as 6-10 weeks postpartum. Therefore, 2D ultrasound could also be a valuable method for demonstrating a LAM abnormality and could be used in settings where 3D/4D ultrasound equipment is not available.

Determination of Anatomical Levels in Spina Bifida Fetuses with Ultrasound and MRI.

PURPOSE: The goal of this study was to assess the accuracy of prenatal anatomical level determination by ultrasound (US) and magnetic resonance imaging (MRI) by analyzing the congruence with the "true" anatomical level identified by postnatal MRI. PATIENTS AND METHODS: The first 60 patients undergoing fetal myelomeningocele surgery at The Zurich Center for Fetal Diangosis and Therapy were included in this study. Anatomical levels (i. e., first dysraphic vertebra) determined by prenatal US and MRI were compared to postnatal MRI. The level of agreement between the imaging modalities was evaluated with a Cohen's kappa test. Results > 0.6 were interpreted as good agreement, > 0.8 as excellent. RESULTS: The exact congruence between prenatal US and MRI compared to postnatal MRI was 33 % and 48 %, respectively, for an accuracy within one level difference of 80 % and 90 %, and within two levels difference of 95 % and 98 %, respectively. The level of agreement of prenatal US and MRI compared to postnatal MRI was 0.62 and 0.79, respectively. Most of the prenatally incorrectly assigned levels were assigned too high (worse) than the "true" level (US 88 % vs. MRI 65 %). CONCLUSION: Reliable exact prenatal level determination by US and MRI is not possible. However, the prenatal determination of the anatomical level of the lesion is good within one level margin of error. Prenatal US as well as MRI demonstrate a systematic error towards higher levels. The above considerations must be integrated into prenatal counselling.

Fetal-Maternal Surgery for Spina Bifida in a HIV-Infected Mother.

INTRODUCTION: In select cases, in utero surgery for myelomeningocele (MMC) leads to better outcomes than postnatal repair. However, maternal HIV infection constitutes a formal exclusion criterion due to the potential of vertical HIV transmission. Encouraged by a previous case of a successful fetal spina bifida repair in a Hepatitis Bs antigen-positive woman, a plan was devised allowing for fetal surgery. CASE REPORT: In utero MMC repair was performed although the mother was HIV-infected. To minimize the risk of in utero HIV transmission, the mother was treated by highly active antiretroviral therapy throughout gestation as well as intravenous zi-dovudine administration during maternal-fetal surgery. The mother tolerated all procedures very well without any sequelae. The currently 20 month-old toddler is HIV negative and has significantly benefitted from fetal surgery. DISCUSSION/CONCLUSION: This case shows that maternal HIV is not a priori a diagnosis that excludes fetal surgery. Rather, it might be a surrogate for moving towards personalized medicine and away from applying too rigorous exclusion criteria in the selection of candidates for maternal-fetal surgery.

Retained placenta and postpartum hemorrhage: time is not everything.

PURPOSE: Postpartum hemorrhage is the major cause of maternal mortality worldwide. Retained placenta accounts for nearly 20% of severe cases. We investigated the influence of the time factor and retained placenta etiology on postpartum hemorrhage dynamics. METHODS: Our retrospective study analyzed a single-center cohort of 296 women with retained placenta. Blood loss was measured using a validated and accurate technique based on calibrated blood collection bags, backed by the post- vs pre-partum decrease in hemoglobin. We evaluated the relationship between these two blood loss parameters and the duration of the third stage of labor using Spearman rank correlation, followed by subgroup analysis stratified by third stage duration and retained placenta etiology. RESULTS: Correlation analysis revealed no association between third stage duration and measured blood loss or decrease in hemoglobin. A shorter third stage (< 60 min) was associated with significantly increased uterine atony (p = 0.001) and need for blood transfusion (p = 0.006). Uterine atony was significantly associated with greater decrease in hemoglobin (p < 0.001), higher measured blood loss (p < 0.001), postpartum hemorrhage (p = 0.048), and need for blood transfusion (p < 0.001). CONCLUSION: Postpartum blood loss does not correlate with third stage duration in women with retained placenta. Our results suggest that there is neither a safe time window preceding postpartum hemorrhage, nor justification for an early cut-off for manual removal of the placenta. The prompt detection of uterine atony and immediate prerequisites for manual removal of the placenta are key factors in the management of postpartum hemorrhage.

Hindbrain Herniation and Banana and Lemon Sign After Open Fetal Myelomeningocele Repair - When Do These Signs Disappear and is Shunting Predictable?

PURPOSE: The aim was to describe the sonographic follow-up of hindbrain herniation (HH), the banana and lemon sign after fetal myelomeningocele (fMMC) repair, and the time of disappearance of these signs after the intervention, and to investigate any predictive value for the necessity of shunting during the infant's first year of life. Additionally, the sonographic evolution of the transcerebellar diameter (TCD) before and after fetal intervention was assessed. PATIENTS AND METHODS: The first 50 patients that underwent fMMC repair at Zurich Center for Fetal Diagnosis and Therapy (www.swissfetus.ch) were included in this study. Sonographic scans performed weekly after fMMC repair focusing on HH and banana and lemon signs were analyzed and compared between the shunted and the non-shunted group. ROC curves were generated for the time intervals of resolution of the signs in order to show their predictive accuracy for the need for shunting until 1 year of age. RESULTS: HH resolved in 48 fetuses (96 %) before delivery. The sonographic disappearance of HH within the first two weeks after fMMC repair was associated with a significantly lower incidence of shunt placement (OR 0.19; 95 % CI 0.4-0.9) during the first year of life (p = 0.03). All fetuses with persistent HH before delivery received a shunt. TCD growth was observed in all fetuses. CONCLUSION: The reversibility of HH within two weeks after fMMC repair is associated with an 80 % lower incidence of shunt placement during the infant's first year of life. Moreover, it allows the cerebellum to grow and to normalize its configuration.

Fetal surgery for spina bifida in Zurich: results from 150 cases.

PURPOSE: Over the past 10 years, over 150 fetal spina bifida surgeries were performed at the Zurich Center for Fetal Diagnosis and Therapy. This study looks at surrogates for success and failure of this approach. METHODS: We focused on key outcome parameters including hydrocephalus shunt rate at one year, bladder control at 4, independent ambulation at 3 years, and maternal, fetal, and neonatal complications. RESULTS: From the first 150 patients undergoing fetal surgery for spina bifida, 148 (98.7%) were included in the study. Maternal-fetal surgery was uneventful in 143/148 (97%) cases. Intraoperative problems included resuscitation in 4/148 fetuses (2.7%). 1/148 fetuses (0.7%) died on postoperative day 4. Maternal complications included chorioamniotic membrane separation in 22/148 (15%), lung embolism in 3/148 (2.1%), chorioamnionitis in 2/148 (1.4%), AV-block III and uterine rupture in 1/148 each (0.7%). 1/148 (0.7%) newborn death was recorded. Hindbrain herniation was identified preoperatively in 132/148 (90%) fetuses and resolved completely in 119/132 (90%). At one year, 39/106 (37%) children had required a CSF diversion. At 4 years, 4/34 patients (12%) had normal bladder control. At 3 years, 48/57 (84%) walked independently. CONCLUSION: A majority of patients benefitted from prenatal intervention, in that the shunt rate was lower and the rates of continent and walking patients were higher than reported with postnatal care.

Minimally Invasive Precise Application of Bioadhesives to Prevent IPPROM on a Pregnant Sheep Model.

INTRODUCTION: Iatrogenic preterm premature rupture of the membrane remains the Achille's heel of fetoscopy. The aim of this study was to show in vivo feasibility of fetal membrane (FM) defect sealing by the application of tissue glues with umbrella-shaped receptors. METHODS: First, we adapted our previously described ex vivo strategy and evaluated the adhesion strength of different tissue glues, Histoacryl® and Glubran2®, by bonding polytetrafluoroethylene or silicone encapsulated nitinol glue receptor to human FM. Then, we exposed pregnant sheep uterus through a laparotomy and placed a 10-French trocar into the amniotic cavity through which the umbrella-shaped glue receptor (n = 9) was inserted and fixated onto the FM with the tissue glues (n = 8). The tightness of the sealed defects was assessed 4 h post-surgery. RESULTS: Both tissue glues tested resulted in adhesion of the glue receptors to the FM ex vivo. In vivo, all glue receptors opened in the amniotic cavity (n = 9) and all successfully placed glue receptors sealed the FM defect (n = 8). Four hours post-surgery, 2 treatment sites showed minimal leakage whereas the negative control without glue (n = 1) showed substantial leakage. DISCUSSION: This in vivo study confirms that fetoscopically induced FM defects can be sealed by the application of tissue adhesives.

[Placental Locations in Subsequent Pregnancies - A Retrospective Study]. / Plazentalokalisationen in aufeinanderfolgenden Schwangerschaften ­ eine retrospektive Kohortenstudie.

INTRODUCTION: Different locations of the placenta are associated with specific risks during pregnancy and labor. Knowledge of the placental location helps to provide better care for the expectant mother and her unborn child. Whereas multiple studies show a higher risk for a recurrent placenta previa, hardly any such data is available for any other placental location. The aim of this study was to analyze the frequency of distribution of different placental locations and to evaluate correlations between placental locations in subsequent pregnancies. MATERIAL AND METHODS: In a retrospective cohort study women with singleton pregnancies ≥ 24 gestational weeks who had at least one ultrasound with identification of the placental location and gave birth to their firstborn and at least one more following child at our hospital between 2007 and 2016 were evaluated. Exclusion criteria were multiple pregnancies, abortions, intrauterine fetal death, and fetal malformations. Placental locations were classified into anterior, posterior, fundal, right, left, and previa. RESULTS: Data of 1657 women were analyzed. The most frequent location was anterior, followed by posterior, fundal and lateral, and previa. Statistical analysis showed no significant correlations in subsequent pregnancies regarding placental locations. CONCLUSION: Placental locations in subsequent pregnancies seem not to be influenced by previous pregnancies. Therefore no prognosis for placental location can be made concerning future pregnancies.

Association between the side of levator Ani muscle trauma and fetal position at birth - a prospective observational study.

INTRODUCTION: Trauma of the levator ani muscle (LAM) is common after vaginal birth and can most reliably be diagnosed by 3-dimensional (3D) translabial ultrasound (TLUS). Multiple risk factors are known in general, but not in association to a specific side of the body. Therefore, our aim was to evaluate different impact factors which cause LAM trauma on either side of the body or bilateral by focusing on the fetal position at birth. MATERIAL AND METHODS: As part of a prospective cohort study between 3/2017 and 4/2019, we analyzed vaginal births of nulliparous women with singletons in vertex presentation≥36+0 gestational weeks. We evaluated their pelvic floor for hematomas, partial and complete LAM avulsions by 3D TLUS 2-4 days postpartum and searched for an association between the affected body side and different fetal, maternal and obstetrical factors. RESULTS: 71 out of 213 women (33.3%) suffered from LAM trauma - 17 (23.9%) on the right side, 20 (28.2%) on the left side and 34 (47.9%) bilateral. No association between the different evaluated factors and the affected body side could be identified, except for the quality of fetal heart rate tracing. CONCLUSIONS: No significant impact factors of LAM trauma could be associated with a specific side of the body. Other possible mechanisms need investigation in the future, such as the time of the birth canal and the fetus to adapt to each other, including adequate time for the tissue to stretch and the fetus to rotate into the ideal position within the LAM hiatus. EINLEITUNG: Levatormuskelverletzungen sind häufig nach Vaginalgeburten und können zuverlässig mittels translabialem 3D-Ultraschall diagnostiziert werden. Diverse Risikofaktoren sind hierfür bekannt, allerdings keine hinsichtlich der Assoziation zu einer der beiden Körperseiten. Daher war das Ziel dieser Arbeit, verschiedene Einflussfaktoren im Rahmen vaginaler Geburten zu evaluieren, welche eine Levatorverletzung auf einer der beiden Körperseiten bzw. beidseitig begünstigen, v. a. hinsichtlich der Kindsposition im Geburtskanal. MATERIAL UND METHODIK: In einer prospektiven Kohortenstudie analysierten wir von 3/2017-4/2019 Erstgebärende mit vaginalen Einlingsgeburten aus Schädellage≥36+0 SSW. Wir evaluierten 2-4 Tage postpartal ihren Beckenboden mittels 3D-Ultraschall hinsichtlich Hämatomen sowie partiellen und kompletten Levatoravulsionen und suchten nach Assoziationen zwischen der betroffenen Körperseite und fetalen, maternalen und geburtshilflichen Einflussfaktoren. ERGEBNISSE: Von 213 Frauen erlitten 71 (33.3%) eine Levatorverletzung - 17 (23.9%) rechtsseitig, 20 (28.2%) linksseitig und 34 (47.9%) beidseitig. Es wurden keine Assoziationen zwischen den untersuchten Einflussfaktoren und der betroffenen Körperseite gefunden, bis auf die Qualität der fetalen Herzfrequenz. DISKUSSION: Es konnten keine signifikanten Einflussfaktoren für das Auftreten einer Levatorverletzung einer spezifischen Körperseite eruiert werden. Daher bedarf es in Zukunft der Untersuchung weiterer Mechanismen, wie der Adaptationsvorgänge von Geburtskanal und Fet und der adäquaten Zeit für das Gewebe zur notwendigen Dehnung, v. a. im Bereich der Levatoröffnung.

Prediction of levator ani muscle avulsion by genital tears after vaginal birth-a prospective observational cohort study.

INTRODUCTION: Visible birth tears and levator ani muscle (LAM) trauma are common after birth. For the diagnosis of LAM trauma ultrasound evaluation is advisable. As ultrasound equipment and trained personnel are not available everywhere at all times, we aimed to evaluate whether specific overt birth tears are an indicator for LAM trauma. METHODS: In a prospective cohort study at our center from March 2017-April 2019, we evaluated vaginal births of nulliparous women with singletons in vertex presentation ≥ 36 + 0 gestational weeks for LAM trauma by translabial ultrasound and for overt birth tears by inspection. We then calculated the association of overt birth tears with complete LAM avulsion. RESULTS: Of 213 women, 23.9% had any kind of LAM trauma, with 14.1% being complete avulsions. In univariate analysis, solely high-grade perineal tears (OASIS) were significantly associated with complete LAM avulsions. CONCLUSIONS: Fourteen percent of women suffered a complete LAM avulsion after vaginal birth, with OASIS being the only associated parameter of significance. The occurrence of such trauma might be an indicator for a mismatch between the size of the fetus and the structures of the birth canal, leading to birth trauma. Assessing for LAM trauma by translabial ultrasound in women with OASIS might be worthwhile.

Birth tears after spontaneous and vacuum-assisted births with different vacuum cup systems - a retrospective cohort study.

Objectives Birth tears are a common complication of vaginal childbirth. We aimed to evaluate the outcomes of birth tears first by comparing the mode of vaginal birth (VB) and then comparing different vacuum cups in instrumental VBs in order to better advise childbearing women and obstetrical professionals. Methods In a retrospective cohort study, we analyzed nulliparous and multiparous women with a singleton pregnancy in vertex presentation at ≥37 + 0 gestational weeks who gave birth vaginally at our tertiary care center between 06/2012 and 12/2016. We compared the distribution of tear types in spontaneous births (SBs) vs. vacuum-assisted VBs. We then compared the tear distribution in the vacuum group when using the Kiwi Omnicup or Bird's anterior metal cup. Outcome parameters were the incidence and distribution of the different tear types dependent on the mode of delivery and type of vacuum cup. Results A total of 4549 SBs and 907 VBs were analyzed. Birth tear distribution differed significantly between the birth modes. In 15.2% of women with an SB an episiotomy was performed vs. 58.5% in women with a VB. Any kind of perineal tear was seen in 45.7% after SB and in 32.7% after VB. High-grade obstetric anal sphincter injuries (OASIS) appeared in 1.1% after SB and in 3.1% after VB. No significant changes in tear distribution were found between the two different VB modes. Conclusions There were more episiotomies, vaginal tears and OASIS after VB than after SB. In contrast, there were more low-grade perineal and labial tears after SB. No significant differences were found between different vacuum cup systems, just a slight trend toward different tear patterns.

How do sustained birth tears after vaginal birth affect birth tear patterns in a subsequent birth?

Background Tears are common after vaginal birth, and different impact factors are known. However, the impact of tears from a previous birth to the tears of a subsequent birth is unknown. Therefore, we aimed to evaluate the distribution of birth tear patterns according to the sustained tears in a previous birth, in addition to other impact factors. Methods In a retrospective cohort study, we evaluated all women up to parity 4 with subsequent vaginal, singleton births of vertex presentation at ≥37 + 0 gestational weeks between 1/2005 and 12/2016. Their tears were grouped into tear patterns and were analyzed by parity. Tear patterns in the subsequent births were analyzed in association to the patterns of the previous births and impact factors were evaluated. Results We counted 4017 births in 1855 women [P1: 1368 (34.1%), P2: 1730 (43.1%), P3: 741 (18.4%), P4: 178 (4.4%)]. The frequency of tears and episiotomies decreased with higher parity, whereas the frequency of intact perineum increased. Twenty-eight different unique tear patterns were found. We could show that birth tear patterns changed with increasing parity and were associated with sustained tears in a previous birth. In addition, some impact factors on tear patterns could be identified. Conclusion The distribution of the single tear types is in accordance with the current literature. However, it is new that distinct tear patterns are associated to sustained tear patterns of previous births. Furthermore, we demonstrated some weak associations of tear patterns to certain impact factors, such as more episiotomies, low-grade perineal or vaginal tears isolated or in combination with other tears with increasing fetal weight and head circumference in the higher parities, and with a longer duration of the second stage and the pushing phase in lower parities.