Labor and Delivery Complication

Very preterm (VPT) birth is a major risk condition for child neurological and behavioral development and as well as for parental well-being, mainly due to multiple sources of stress (e.g., separation and pain exposure) during the hospitalization. Even in absence of severe critical medical comorbidities, VPT infants and their parents are exposed to multiple stress sources during the stay in the hospitalization in the Neonatal Intensive Care Unit (NICU), including early parent-infant separation and pain. Early parenting video-feedback (VF) interventions focused on promoting parent-infant closeness through the video-feedback (VF) approach methodology have proven effective in promoting child development and parental well-being. Electroencephalography (EEG) hyperscanning paradigms allow the assessment of brain-to-brain co-regulation during live interaction between infants and parents and hold promises to highlight mechanisms behind the interactive benefits of early VF parenting interventions. The 2-Brain Regulation to Achieve Improved Neuroprotection during Early Development (2-BRAINED) research project aims (a) to compare indexes of brain-to-brain co-regulation between dyads of full-term (FT) and VPT infants interacting with their mothers and (b) to investigate the effect of an early post-discharge VF intervention on the brain-to-brain co-regulation indexes of VPT dyads. The 2-BRAINED project is a randomized-controlled trial (RCT) with three arms (see arm description). VPT (gestational age below 35 weeks) and FT (gestational age above 37 weeks) dyads will be enrolled at birth and the former will be randomly allocated to one of two arms: VF intervention or care as usual. The VF intervention will be delivered during the first three months after NICU discharge, consisting of and consists of 8 weekly remote VF sessions focused on sensory, behavioral, cognitive, and affective dimensions of parenting. Before and after the intervention, videotaped mother-infant interaction will provide pre-post behavioral data to assess the short-term effectiveness of the VF intervention. Videos will be micro-analytically coded for infant's and caregivers' target behaviors. Mothers of VPT and FT infants will fill in questionnaires focused on maternal well-being (symptoms of depression \[Beck Depression Inventory, BDI; Beck et al.,1961\] and anxiety \[State-Trait Anxiety Inventory, STAI-Y, Spielberg, 1983\]), parenting (parental stress and mother-infant bonding \[Parenting Stress Index, PSI; Abidin, 1983\]), and infant development (language \[Italian adaptation of the MacArthur-Bates Communicative Development Inventory; Caselli \& Casadio, 1995\]; temperament \[Infant Behavior Questionnaire Revised, IBQ-R, Gartstein et al., 2003\] and sensory profile \[Sensory Profile 2, SP-2, Dunn, 2014\]) at 3, 6 and 9 months (corrected age, CA). At 9 months CA, all dyads will take part in a lab-based 5-min EEG- hyperscanning Still-Face task (Tronick et al., 1978; Provenzi et al., 2016) in the laboratory to assess brain-to-brain co-regulation, during which EEG activity from both the interactive partners will be recorded using two 32-electrode caps linked with two PC-connected wireless amplifiers (Smarting mBrainTrain) that will assure complete freedom of movements. Several indexes used to measure of brain-to-brain co-regulation will be tested and compared, including Phase-Locking Value (PLV), Amplitude-Amplitude Coupling (AAC) and imaginary coherence (ICoh). These indexes will be used to compare brain-to-brain co-regulation indexes (a) between PT and FT infants to test difference in interpersonal neurophysiological attunement in typical and at-risk infants as well as (b) between PTCU and PTVF. Moreover, best-fitting synchrony indexes will be used in a path analysis model testing the mediating role of brain-to-brain co-regulation indexes on the effects of VF early parental intervention on the short- and long-term outcomes. A prediction model will be implemented to predict outcomes on the basis of both clinical and EEG measures.

The word placenta accreta spectrum disorders (PASD) implies an atypical implantation of the placenta into the uterine wall and has been used to express placenta accreta, increta and percreta. Placenta accreta is a placenta where the placental villi sick on directly to the myometrium. Placenta increta is a placenta where the placental villi attack into the myometrium and placenta percreta is a placenta where the villi invade through the myometrium and into serosa. No antenatal diagnostic method gives the clinician 100% assurance of either ruling in or ruling out the existence of placenta accreta. The definitive diagnosis of placental accreta spectrum is frequently ended postpartum on hysterectomy specimens when an area of accretion shows chorionic villi which make direct contact with the myometrium and absence of deciduae. Antenatal ultrasound is the method of choice used to establish the diagnosis and direct clinical management.The combined use of power Doppler with three dimensional (3D) ultrasound provides the possibility of quantifying moving blood within a volume of interest. Three indices are calculated, namely vascularization index (VI), flow index and vascularization flow index

Currently, high resolution anorectal manometry (HDARM) is used as gold standard to measure anal sphincter pressures in women who have sustained a third or fourth degree perineal tears (obstetric anal sphincter injuries). This test is performed to help advise patients on future pregnancies or deliveries. However, HDRM catheters are very expensive and they also need to be performed in a dedicated procedure room. THD® Anopress in comparison is a lightweight, portable device which has a comparatively shorter investigation time and is more cost- effective. However, although THD® Anopress is currently used in the colorectal population, there is currently no validated research that compares the measurements obtained by HDARM with that of THD® Anopress with women with a history of obstetric anal sphincter injuries. The primary aim of this study is to compare pressure measurements from HDARM to that of THD® Anopress in women with obstetric anal sphincter injuries.

The informed consent process is an important part of any surgical and anesthetic intervention. It is also perhaps the most intellectually demanding portion of interacting with the healthcare system for patients. Competent patients have full autonomy over which treatments they receive, and making an informed choice about the decision to undergo a treatment requires at minimum a discussion of the proposed intervention, its risks and benefits, and alternatives to the proposed intervention. The objective is to improve the anesthesia informed consent process for patients undergoing elective Caesarean delivery through the use of a pre-recorded audiovisual presentation that discusses the logistical aspects of perioperative care and the risks and benefits of anesthesia which is provided to patients prior to meeting their anesthesiologist. The hypothesis is that the use of an audiovisual presentation which explains the purpose and nature of anesthesia for Caesarean delivery provided to the patient at least 24 hours prior to their procedure will result in a 10% increase in the effectiveness of risk communication and treatment decision making as measured by the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) tool.

The investigator will recruit female patients treated before 40 years with pelvic radiation (PRT) at least 12 months prior to study initiation.12 months is selected to increase the occurrence of uterine fibrosis. The investigator will perform transabdominal standard B-mode and Doppler US, SWE and pelvic MRI and characterize uterine parameters. The B-mode and Doppler US will be referred to collectively as US. This will provide essential information to design an intervention trial of a novel therapeutic approach to the treatment of radiation-induced uterine damage. The overall objective of the study will be achieved through the following specific aims: Aim 1: Assess the feasibility of SWE and pelvic MRI to identify and characterize uterine fibrosis. Hypothesis: A grid map sampling of the uterus will indicate feasibility of SWE and pelvic MRI to detect and characterize uterine fibrosis. Approach: SWE and MRI will be performed at time of study recruitment. US procedures will be transabdominal. When possible, and with participant consent, transvaginal US will also be performed. MRI images will also be sampled from existing pretreatment studies performed as standard of care. Perform SWE and MRI sampling of the uterus from fundus to lower uterine segment at two locations each from the upper, mid, and lower thirds of the uterus (six grid sample locations). Obtain five measurements at each location to evaluate for the presence and degree of fibrosis: 1. Assess the relationship between SWE measurements in kiloPascals (kPa) and each MRI parameter among cases at the post-treatment timepoint. 2. Assess the relationship between SWE measurements and each MRI parameter in kPa among controls at one random timepoint. 3. Evaluate differences in kPa between cases and controls according to SWE at the post-treatment timepoint. The imaging study will be considered feasible if at least 85% (e.g., ≥15/17) of all enrolled cases achieve the diagnosability criteria by SWE, defined as having the interquartile range to median ratio (IQR/M) of the measurements (kPa) \<=30% at any of the six locations. Aim 2: Characterize uterine parameters after PRT. Hypothesis: Patients treated with PRT for colorectal/anal cancer will have decreased uterine volume and increased arterial resistive indices (blood flow) on US. Approach: 2a. Perform US and estimate uterine volumes and arterial resistance. Use descriptive statistics to compare values to controls in the same age group. 2b. Perform MRI and describe changes in each parameter among cases between the pre- and post-treatment timepoints. Assess changes in: size of the uterus from baseline, junctional zone anatomy, endometrial thickness, cervical length, myometrial thickness, T2 signal of the myometrium (normalized for skeletal muscle signal acting as an internal control), and enhancement features.

Investigators are using a pseudo randomized yoked design and will include two groups: choice of intervention strategy or no-choice. If the individual is randomized to no choice, then the next person would get a choice and the no choice person would be assigned to the group yoked (matched) to the person with a choice. Participants assigned to the choice group will choose one of three intervention strategies provided; either Group A (receiving both nutrition and exercise simultaneously), B (starting with nutrition and receiving exercise sequentially followed by nutrition starting at 25 weeks) or C (starting with nutrition first and then introducing exercise sequentially at 25 weeks). All groups will follow the full NELIP until delivery. Participants in the no-choice group will be yoked (matched) to a participant in the choice group and receive the strategy that their yoked counterparts chose. Nutrition component of NELIP: This component is a modified gestational diabetic meal plan that has four general goals tailored to the participant: (1) to achieve approximately 2000 kcal of energy per day. The determination of the amount of kcal consumed per day will consider the participant's intake from the dietary assessment. There also must not be a restriction of calories that exceeds 30% of their total energy intake; (2) participants will consume approximately 200-250g/day of carbohydrates, accounting for approximately 40-55% of total energy intake. Carbohydrate intake will be distributed throughout three meals and four snacks daily. The nutritionist will educate participants about the importance of complex and low-glycemic index carbohydrates through the one-on-one session; (3) fat and protein intake will be approximately 30% and 20-30% of total energy intake, respectively; (4) achieve appropriate micronutrient and fluid intake for pregnancy. This will be monitored by a weekly 24 hour food intake record. Exercise component of NELIP: This is a walking program that comprises of 1 weekly supervised session on a treadmill or outside and participants will be recommended to walk 2 to 3 additional times per week. The walking program will start at 25 minutes per session, 3 to 4 times weekly, and increase by 2 minutes per week until 40 minutes and then maintained until delivery. This will be monitored by a wrist monitoring device. The primary outcome is adherence measured weekly using a published adherence protocol using a point system. Secondary outcomes are participant satisfaction to the program and health outcomes: weekly weight gain, calculated EGWG, and pregnancy outcomes (birth weight length, infant anthropometrics, APGAR scores and delivery complications). At 2, 6 and 12 months of age the maternal-infant dyad will return to the lab and infant morphometric measurements recorded from birth will be repeated.

Postpartum hemorrhage (PPH) is a common complication following vaginal or cesarean delivery and contributes significantly to maternal morbidity and mortality in the United States. There are numerous clinical factors which contribute to a patient's risk of developing PPH. Utilization of an evidence-based tool for PPH risk prediction is recommended by national societies and required by the Joint Commission. Most currently used tools are category based and assign a low, medium, or high risk of hemorrhage. These tools fail to take advantage of the vast amounts of data and computing power available via modern electronic medical records. Predictive modeling and informatics-based solutions could help to modernize PPH risk prediction and improve patient outcomes. This study proposes to continue standard of care risk assessment for all patients, including those randomized to the intervention arm (ARM B). Those patients in the intervention arm (ARM B) will have an additional risk prediction displayed, which will show the quantitative output from the logistic regression PPH risk prediction model, (validated in a previous study). In addition to this display, patients above a preset threshold of 3% risk will have a Best Practice Advisory (BPA) deployed to clinicians with recommended actions. These recommended actions, including the prophylactic use of tranexamic acid and second-line uterotonics, are supported by best evidence in those patients deemed to be at elevated a priori risk of PPH. These prophylactic treatments are accepted standard of care for those patients deemed high risk, and may be administered, at the discretion of the covering clinician, to patients rated high risk by the current risk assessment tool in the comparator arm (Arm A) of the study. The recommendations within the best practice advisory serve as a reminder of best practices as defined by the department and providers are not forced to follow the recommendations of the best practice advisory.

The current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (PCOS) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for GDM and other complications in PCOS patients.

The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants who undergo intrauterine procedures with these devices. The scopes will be used to assist in intrauterine procedures across a variety of fetal conditions, such as TTTS (twin-twin transfusion syndrome), TAPS (twin anemia polycythemia sequence), sFGR (selective fetal growth restriction) or TRAP sequence (twin reversed arterial perfusion). Fetoscopic laser photocoagulation (FLP) can also be used during in-utero surgery to correct abnormal vessels in cases like chorioangioma or vasa previa. Other complex congenital anomalies may require fetal intervention or diagnostic fetoscopy using Storz scopes. Improvements in the technique, experience and equipment have been associated with better maternal, fetal, and neonatal outcomes in fetal surgery. Smaller fetoscopes are associated with lower rates of premature delivery following FLP. New fetoscopes (11508AAK and 11506AAK) have the potential to improve visualization and the photocoagulation angle. Compared to alternative scopes, these Storz scopes provide a wider angle of view and are longer, enabling better reach to distant areas at the edge of the placenta, especially in cases of higher BMI, higher gestational age, and significant polyhydramnios. This study is an un-blinded, non-randomized, single arm, feasibility study on a convenience cohort to demonstrate the role of a curved fetoscope device (11508AAK) or straight fetoscope device (11506AAK) among in-utero surgeries. Patients will be enrolled in a consecutive manner and all qualifying, patients who agreed to the use of the curved or straight fetoscopes will be enrolled in the study. Outcome data will be reported as a descriptive statistical analysis. The curved fetoscope (11508AAK) device will be used in monochorionic pregnancies with an anterior placenta requiring in-utero surgery, while the straight fetoscope (11506AAK) will be used in monochorionic pregnancies with a posterior placenta. This device is classified as a significant risk device because it is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.

The purpose of this study is to determine whether participation in the Play and Learning Strategies (PALS) parenting intervention results in increased caregiver responsiveness behaviors and to test if participation in PALS results in increases in toddler skills and/or toddler neurological development.