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.

A randomized control trial of continuous support in labor by a lay doula.

OBJECTIVE: To compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group). DESIGN: Randomized controlled trial. SETTING: A women's ambulatory care center at a tertiary perinatal care hospital in New Jersey. PATIENTS/PARTICIPANTS: Six hundred nulliparous women carrying a singleton pregnancy who had a low-risk pregnancy at the time of enrollment and were able to identify a female friend or family member willing to act as their lay doula. INTERVENTIONS: The doula group was taught traditional doula supportive techniques in two 2-hour sessions. MAIN OUTCOME MEASURES: Length of labor, type of delivery, type and timing of analgesia/anesthesia, and Apgar scores. RESULTS: Significantly shorter length of labor in the doula group, greater cervical dilation at the time of epidural anesthesia, and higher Apgar scores at both 1 and 5 minutes. Differences did not reach statistical significance in type of analgesia/anesthesia or cesarean delivery despite a trend toward lower cesarean delivery rates in the doula group. CONCLUSION: Providing low-income pregnant women with the option to choose a female friend who has received lay doula training and will act as doula during labor, along with other family members, shortens the labor process.

Transabdominal fetal pulse oximetry with near-infrared spectroscopy.

OBJECTIVE: The purpose of this study was to determine the feasibility of noninvasive fetal pulse oximetry in the human fetus with transabdominal continuous-wave near-infrared spectroscopy. STUDY DESIGN: The instrument has 3 wavelength light-emitting diodes (735, 805, and 850 nm) as light sources and a photomultiplier tube as a detector. This instrument was used in 6 pregnant women (>36 weeks of gestation). First, a fetal heart rate was obtained with a fetal heart rate monitor. Then, the depth of fetal tissue (head) from the maternal abdomen was determined by ultrasound examination; the distance between the optodes (light source and the detector) was set to be approximately twice the depth of the fetus (7-11 cm). The data analysis was based on the modified Beer-Lambert law and the use of optical densities at 735 and 850 nm to obtain the concentration changes of the oxyhemoglobin and deoxyhemoglobin. The saturation was expressed as the percent of oxygen saturation equal to 100 x oxyhemoglobin/(oxyhemoglobin + deoxyhemoglobin). We recorded the spectroscopy data and the fetal heart rate for approximately 3 to 10 minutes in each patient. RESULTS: The mean oxygen saturation values of each of the 6 individual fetuses ranged from 50% to 74% (overall mean saturation, 61% +/- 14.8% [SD]). CONCLUSION: This preliminary data indicate that transabdominal fetal pulse oximetry is feasible for human patient application. The measured values were similar to those that are obtained with transvaginal pulse oximetry. Future studies should correlate transabdominally obtained measurements with those measurements that are obtained by transvaginal fetal pulse oximetry.

The effect of computer-assisted evaluation of labor on cesarean rates.

Dystocia, or slow labor, is the leading cause of first-time cesarean sections. Current diagnostic guidelines for dystocia are vague, and there is no clear postoperative confirmatory evidence to assess the correctness of this diagnosis. For several decades, various professional organizations have indicated that cesarean rates could be lowered safely and have recommended levels that are far below national averages. The three major factors, of roughly equal importance, associated with cesarean for slow labor are the baby's weight, the mother's height, and the threshold at which the physician believes it is reasonable to intervene. The last is the only modifiable factor, and quality programs are a major part of changing medical behavior. By using two study designs, the effect of a mathematical method for evaluating labor progress on the rate of cesarean section was measured. In the prospective randomized clinical trial, the relative risk of cesarean in the experimental group was unchanged at 1.04. In the pretest-posttest analysis, the rates fell from 19.54% to 17.04% at 6 months and 16.62% at 12 months.