John Y. Phelps

Normal values of urinary albumin and total protein excretion during pregnancy

OBJECTIVE Our purpose was to determine the normal 24-hour excretion values of urinary albumin and total protein in healthy pregnant women. STUDY DESIGN We evaluated 270 healthy pregnant women < or = 35 years old without a history of diabetes, hypertension, pyelonephritis, preeclampsia, or renal or connective tissue disease. Adequacy of 24-hour collection was determined by creatinine excretion. RESULTS The mean protein excretion in 24 hours was 116.9 mg, upper 95% confidence limit 259.4 mg. The mean albumin excretion in 24 hours was 11.8 mg, upper 95% confidence limit 28.7 mg. Both protein and albumin excretion increased after 20 weeks of gestation. No patient had evidence of microalbuminuria, defined as urinary albumin excretion > 30 mg/L. CONCLUSION These data support 260 mg per 24 hours of urinary protein and 29 mg per 24 hours of albumin as the upper limit of normal in pregnancy. Albumin accounts for a small fraction of total urinary protein excretion.

Accuracy and intraobserver variability of simulated cervical dilatation measurements

OBJECTIVE Our purpose was to assess the accuracy and intraobserver variability of clinical cervical diameter measurements among obstetric health care providers. STUDY DESIGN Polyvinyl chloride pipes 1 to 10 cm in diameter were mounted in cardboard boxes and used to simulate cervical examinations. The boxes were designed so that the examiner had to rely solely on proprioception to determine the inner diameter. RESULTS A total of 1574 simulated cervical diameter measurements were obtained from 102 different examiners in a two-part study. The overall accuracy for determining the exact diameter was 56.3%, which improved to 89.5% when an error of +/- 1 cm was allowed. Intraobserver variability for a given diameter measurement was 52.1%, which decreased to 10.5% when an error of +/- 1 cm was allowed. CONCLUSIONS Cervical diameter measurements obtained by digital examination are precise when an error of +/- 1 cm is allowed for. Intraobserver variability is > 50% and is an important consideration when evaluating dysfunctional labor.

Day 4 estradiol levels predict pregnancy success in women undergoing controlled ovarian hyperstimulation for IVF.

OBJECTIVE To evaluate the usefulness of serum estradiol levels obtained on the fourth day of gonadotropin stimulation in predicting the likelihood of pregnancy during controlled ovarian hyperstimulation (COH) using luteal phase leuprolide acetate (LA). DESIGN A 4-year retrospective analysis of day 4 estradiol levels and subsequent clinical pregnancy and delivery rates. SETTING A university hospital tertiary referral center. PATIENT(S) Couples undergoing IVF treatment. MAIN OUTCOME MEASURE(S) Primary outcome measures included clinical pregnancy and delivery rates. Secondary outcome measures included the number of oocytes retrieved and the number of embryos available for transfer per COH cycle. RESULT(S) The clinical pregnancy and delivery rates for cycles with day 4 estradiol levels of >75 pg/mL were 42.3% (30/71) and 32.4% (23/71), respectively. These rates differed significantly from those for cycles with day 4 estradiol levels of < or = 75 pg/mL, which were only 9.1% (4/44) and 6.8% (3/44), respectively. The number of oocytes retrieved and the number of embryos available for transfer for cycles with day 4 estradiol levels of >75 pg/mL also differed significantly from those for cycles with day 4 estradiol levels of < or = 75 pg/mL (11.4 and 7.8 versus 6.8 and 4.3, respectively). CONCLUSION(S) Estradiol levels obtained on the fourth day of gonadotropin therapy are highly predictive of successful ovulation induction and pregnancy outcome in cycles using luteal phase LA.

Comparison of Perioperative Outcomes of Total Laparoscopic and Robotically Assisted Hysterectomy for Benign Pathology during Introduction of a Robotic Program

Study Objective. Prospectively compare outcomes of robotically assisted and laparoscopic hysterectomy in the process of implementing a new robotic program. Design. Prospectively comparative observational nonrandomized study. Design Classification. II-1. Setting. Tertiary caregiver university hospital. Patients. Data collected consecutively 24 months, 34 patients underwent laparoscopic hysterectomy, 25 patients underwent robotic hysterectomy, and 11 patients underwent vaginal hysterectomy at our institution. Interventions. Outcomes of robotically assisted, laparoscopic, and vaginal complex hysterectomies performed by a single surgeon for noncancerous indications. Measurements and Main Results. Operative times were 208.3 ± 59.01 minutes for laparoscopic, 286.2 ± 82.87 minutes for robotic, and 163.5 ± 61.89 minutes for vaginal (P < .0001). Estimated blood loss for patients undergoing laparoscopic surgery was 242.7 ± 211.37 cc, 137.4 ± 107.50 cc for robotic surgery, and 243.2 ± 127.52 cc for vaginal surgery (P = 0.05). The mean length of stay ranged from 1.8 to 2.3 days for the 3 methods. Association was significant for uterine weight (P = 0.0043) among surgery methods. Conclusion. Robotically assisted hysterectomy is feasible with low morbidity, a shorter hospital stay, and less blood loss. This suggests that robotic assistance facilitates a minimally invasive approach for patients with larger uterine size even during implementing a new robotic program.

Spontaneously developed tail swellings (SDTS) influence the accuracy of the hypo-osmotic swelling test (HOS-test) in determining membrane integrity and viability of human spermatozoa

PurposeTo investigate the prevalence of spontaneously developed tail swellings (SDTS) in human sperm samples that are commonly encountered in the laboratory, and their influence on the hypo-osmotic swelling test (HOS-test).MethodsEjaculated, epididymal, and testicular sperm were evaluated for SDTS. Further, HOS-test scores were compared with those of vital stains using column washed sperm maintained in the laboratory.ResultsSDTS, at <10%, was present in all types of sperm samples. The highest and lowest occurrences of SDTS were found in cryopreserved sperm, and column-washed sperm respectively. SDTS can inflate the HOS-test score, and so lower the accuracy of the HOS-test. However, the HOS-test efficiency can be improved by assessing SDTS in the sample.ConclusionHOS-test and vital stain cannot be used interchangeably in all circumstances for sperm viability determination. The accuracy of the HOS-test can be enhanced by incorporating SDTS as a correction factor.

Prolactin gene expression in human ovarian follicular cells.

OBJECTIVE To investigate prolactin gene expression in human ovarian follicular cells. DESIGN RNA was isolated from follicular cells obtained at the time of transvaginal oocyte retrieval from patients after controlled ovarian hyperstimulation. The RNA was subjected to reverse transcription and polymerase chain reaction (RT-PCR) using prolactin-specific primers. The RT-PCR products were analyzed by gel electrophoresis, followed by Southern blot analysis using prolactin-specific probes. SETTING Department of gynecology and obstetrics research laboratory. PATIENT(S) Women undergoing controlled ovarian hyperstimulation followed by transvaginal oocyte retrieval. INTERVENTION(S) Controlled ovarian hyperstimulation followed by transvaginal oocyte retrieval. Expression of prolactin mRNA by follicular cells. RESULT(S) The presence of prolactin-specific cDNA amplified by RT-PCR from RNA isolated from human follicular cells was confirmed by Southern blot analysis. CONCLUSION(S) Human ovarian follicular cells are an extrapituitary site of prolactin gene expression.

A Medical-Legal Review of Power Morcellation in the Face of the Recent FDA Warning and Litigation

Minimally invasive gynecologic surgeons who perform laparoscopic intraperitoneal morcellation should be aware of the recent US Food and Drug Administration (FDA) warning and litigation arising from use of morcellation devices with claims of intraperitoneal dissemination of cancerous cells. On November 24, 2014, the FDA issued a statement warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Despite the best intentions in regards to their patients, gynecologists who continue to use power morcellation devices expose themselves to liability. This article is not meant to further deter gynecologists from using laparoscopic power morcellators, but rather to provide an interpretation of the FDA statement as to the patients for whom the use of power morcellation may still be permitted under the FDA guidelines. This article also offers protective measures from a legal perspective for those who choose to continue to use power morcellation in the face of the recent FDA warning and litigation.

Intermedin/Adrenomedullin 2 Is Associated With Implantation and Placentation via Trophoblast Invasion in Human Pregnancy

RATIONALE Intermedin (IMD) is a novel peptide expressed in trophoblast cells in human placenta and enhances the invasion, migration, and human leukocyte antigen class I, G (HLA-G) expression in first-trimester HTR-8SV/neo cells. We recently reported that infusion of IMD antagonist in pregnant rats is detrimental to pregnancy outcome, resulting in impaired fetoplacental growth and deformed placental vasculature. OBJECTIVE This study was undertaken to assess expression of IMD and its involvement in human implantation and early placentation and assess whether its expression is altered in spontaneous abortion. FINDINGS AND CONCLUSIONS We demonstrate for the first time that IMD is present in day 5 embryonic secretome; villous and decidual expression of IMD is higher at 6-8 weeks after a decline as gestation advances toward the second trimester; first-trimester spontaneous abortion is associated with a lower expression of IMD in serum, villi, and decidua; IMD stimulates the invasive capacity of first-trimester primary Extravillous cytotrophoblast cells; and IMD decreases elevated levels of tumor suppressor Kangia-1 in decidual explants from first-trimester spontaneous abortion. In conclusion, this study is the first to demonstrate a potential involvement of IMD in human embryo implantation and placental development via regulation of trophoblast invasion at the maternal-fetal interface and suggests a physiological role for this novel peptide in establishment of human pregnancy.

Enmeshed in Controversy: Use of Vaginal Mesh in the Current Medicolegal Environment.

&NA; Vaginal mesh has been a valuable tool in the treatment of stress urinary incontinence and pelvic organ prolapse. As our knowledge of the long-term outcomes and complications of this product has evolved, however, vaginal mesh has become the subject of legal scrutiny. Therefore, it is imperative that physicians understand pertinent litigation techniques to optimize their informed consent and documentation processes and protect themselves. Objectives Our objective is to familiarize physicians who use vaginal mesh with how law suits involving transvaginal mesh are construed. We also describe the current medicolegal environment surrounding the use of these products. Methods The food and drug administration public safety communications, food and drug administration Manufacturer and User Facility Device Experience database, and LexisNexis legal search engine were used to review data relevant to current vaginal mesh litigation. This information was used to create a medicolegal review. Results Litigation involving transvaginal mesh follows 3 paths. The first consists of claims against the manufacture of transvaginal mesh with allegations, such as design defects, failure to warn, and misrepresentation. The second is a defensive legal strategy called the learned intermediary doctrine, used by manufacturers to shift liability from themselves to surgeons. The manufacturers claim that the duty to inform patients of potential complications lies with the surgeon. The third involves claims by patients against surgeons for lack of informed consent, alleging that they were not sufficiently informed of potential complications associated with transvaginal mesh before insertion. Conclusions To lessen the liability, a surgeon using transvaginal mesh should inform patients of potential complications associated with the products and document informed consent in their medical records.

Avoiding legal pitfalls in surrogacy arrangements

The goal of this article is to discuss the legal pitfalls that reproductive endocrinologists face when participating in gestational surrogacy contracts. This paper was composed using Westlaw and LexisNexis commercial legal search engines to perform a review of statutes and cases pertaining to gestational surrogacy. The search results demonstrated that in the absence of suitable preparation, there is significant potential for litigation while participating in gestational agreements. Providers caring for gestational carriers have been named as parties in lawsuits for failure to provide psychological screening, failure to screen for infectious disease and participation in gestational contracts that are not compliant with state law. There is great disparity in state laws and court rulings pertaining to gestational agreements. When legal disputes arise, individual state laws and court rulings are controlling over the Uniform Parentage Act. Likewise, recommendations by the American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine do not supersede state laws. The failure to abide by individual state laws unnecessarily exposes reproductive endocrinologists and their IVF facilities to potential litigation. In order to lessen exposure to litigation, an understanding of individual state legislation or historical court rulings is advised.