Maternal outcomes of a cohort of pregnancies affected by non-immune hydrops fetalis.

OBJECTIVE: To describe the maternal outcomes of a prospective cohort of non-immune hydrops fetalis (NIHF) pregnancies with negative standard-of-care evaluations. METHODS: This study was a secondary analysis of a prospective cohort study of NIHF pregnancies with negative work-ups (infection, alloimmune anemia, fetomaternal hemorrhage, and chromosomal disorders). Outcomes were obstetric complications, including pre-eclampsia, mirror syndrome, preterm birth, polyhydramnios, postpartum hemorrhage, and maternal mental health. RESULTS: Forty pregnancies were included. Four patients developed pre-eclampsia (4/40, 10.0%); three occurred postpartum. None was diagnosed with mirror syndrome. Of the 31 continued pregnancies, 16 (51.6%) resulted in early fetal death or stillbirth and 15 (48.4%) resulted in live births. Of the 15 live births, 8 (53.3%) were delivered by primary cesarean delivery; 5 (62.5%) were for hydrops fetalis. Eleven live births (73.3%) were delivered preterm; 9 (81.8%) were indicated, most commonly for fetal indications (7/9, 77.8%). Polyhydramnios occurred in 14/40 (35.0%) cases. Where EBL was recorded (n=37), there were 5 (13.5%) cases of postpartum hemorrhage and an additional 3 (8.1%) had uterine atony without hemorrhage. Eighteen patients (18/40, 45.0%) had new-onset or exacerbated depression or anxiety symptoms. CONCLUSION: Our study identified several important adverse outcomes of pregnancies complicated by NIHF with negative standard-of-care evaluations, including a high rate of postpartum pre-eclampsia and worsened mental health. We identified a higher rate of cesarean delivery and preterm birth, both primarily for fetal indications. We also observed the known relationship between polyhydramnios, hemorrhage, and atony, but noted that this risk included pregnancies concluding in dilation and evacuation. Counseling after a diagnosis of NIHF should include these adverse outcomes.

High diagnosis rate for nonimmune hydrops fetalis with prenatal clinical exome from the Hydrops-Yielding Diagnostic Results of Prenatal Sequencing (HYDROPS) Study.

PURPOSE: Nonimmune hydrops fetalis (NIHF) presents as life-threatening fluid collections in multiple fetal compartments and can be caused by both genetic and non-genetic etiologies. We explored incremental diagnostic yield of testing with prenatal exome sequencing (ES) for NIHF following a negative standard NIHF workup. METHODS: Participants enrolled into the Hydrops-Yielding Diagnostic Results of Prenatal Sequencing (HYDROPS) study met a strict definition of NIHF and had negative standard-of-care workup. Clinical trio ES from fetal samples and parental blood was performed at a CLIA-certified reference laboratory with clinical reports returned by geneticists and genetic counselors. Negative exomes were reanalyzed with information from subsequent ultrasounds and records. RESULTS: Twenty-two fetal exomes reported 11 (50%) diagnostic results and five possible diagnoses (22.7%). Diagnosed cases comprised seven de novodominant disorders, three recessive disorders, and one inherited dominant disorder including four Noonan syndromes (PTPN11, RAF1, RIT1, and RRAS2), three musculoskeletal disorders (RYR1, AMER1, and BICD2), two metabolic disorders (sialidosis and multiple sulfatase deficiency), one Kabuki syndrome, and one congenital anemia (KLF1). CONCLUSION: The etiology of NIHF predicts postnatal prognosis and recurrence risk in future pregnancies. ES provides high incremental diagnostic yield for NIHF after standard-of-care testing and should be considered in the workup.

Novel device vs manual examinations for the measurement of cervical dilation in labor: a randomized controlled trial.

BACKGROUND: Cervical dilation and changes in cervical dilation inform the management of labor, including decisions to admit a patient to the hospital, augment labor, or perform a cesarean delivery. Practitioners routinely measure cervical dilation subjectively using 2 fingers on manual examination; however, agreement of ≤1 cm between 2 observers has been reported as 60% to 91% previously in laboring women. OBJECTIVE: To evaluate the agreement among different providers' examinations using DilaCheck (interexaminer agreement) compared with interexaminer agreement between 2 manual examinations for cervical dilation of women in labor. STUDY DESIGN: Women admitted in labor to a labor and delivery service were randomized to receive 2 cervical examinations from trained providers, using either a novel device (DilaCheck) or the standard manual examination. This randomized controlled trial compares a novel device with the standard method of manual examination for the measurement of cervical dilation. The novel device consisted of a string measuring tape suspended between 2 soft plastic rings worn on the index and middle fingertips. Interobserver agreement, defined as the agreement (exact, ≤1 cm [primary outcome], or ≤2 cm) in the numeric cervical dilation measurement obtained by 2 different examiners, was compared between the 2 groups. RESULTS: A total of 42 women in labor were randomized, 21 to the novel device and 21 to the standard manual examination groups. The 2 device examinations agreed in 19% of cases, whereas manual examinations agreed exactly in 42.9% of cases (P=.10). Interobserver agreement of ≤1 cm was 61.9% vs 95.2%, respectively (P=.008). Interobserver agreement of ≤2 cm was 90.5% vs 100%, respectively (P=.15). Most interobserver disagreement was seen at 5 to 7 cm of cervical dilation. CONCLUSION: A novel device, DilaCheck, intended for a more objective cervical assessment of women in labor did not improve interobserver agreement; in fact, it decreased it. Standard cervical dilation examinations result in poor interexaminer exact agreement, usually at best 50% or less. Clinical management should be based on clinical differences of >1 cm because, in general, 90% of cervical examinations will agree within 1 cm of each other. Given the importance of dilation measurements in the management of labor, continued innovation in this field would benefit women in labor and the providers caring for them; however, the puzzle remains unsolved.

A Multicenter Investigation of Factors Influencing Women's Participation in Clinical Trials.

OBJECTIVE: To identify factors that influence women's participation in clinical research. METHODS: We administered a survey in outpatient and inpatient populations of Obstetrics and Gynecology facilities of six institutions located in four states. The survey included questions regarding any of the participant's past experiences in clinical research and the factors that would influence their participation in clinical research. Analyses included descriptive statistics and a Principal Component Analysis. RESULTS: The analysis included 3,773 respondents; 2,477 (68.1%) were pregnant. The majority of participants were Caucasian (1,453, 40.2%), followed by Hispanic (933, 25.8%), African American/black (744, 20.6%), other minorities (270, 7.5%), and multiracial (212, 5.9%). Ten potential motivating factors and 10 potential barriers were assessed. The greatest motivating factor was "how well research is explained" (mean = 2.87) while "risk of unknown side effects" was the greatest barrier (mean = 3.07) for women's participation in clinical trials. Among six helpful resources assessed, "material in my own language" was scored as the highest (mean = 2.8) in facilitating women's decision to participate. For "risk to the fetus/future fertility" as a barrier, pregnant women's score (mean = 3.25) was significantly higher than nonpregnant women's score (mean = 2.37). CONCLUSIONS: Overall, the risk of unknown side effects discourages women in general, and the risk to the fetus/future fertility discourages pregnant women the most from participating in clinical trials. However, explaining a study well and providing written material in the patients' own language may increase their willingness to participate.