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.

Female relatives or friends trained as labor doulas: outcomes at 6 to 8 weeks postpartum.

BACKGROUND: Data collected on more than 12,000 women in 15 randomized controlled trials provide robust evidence of the beneficial effects of doula support on medical outcomes to childbirth. The objective of this paper was to examine the association between doula support and maternal perceptions of the infant, self, and support from others at 6 to 8 weeks postpartum. The doula was a minimally trained close female relative or friend. METHODS: Six hundred low-risk, nulliparous women were enrolled in the original clinical trial and randomized to doula support (n = 300) or standard care (n = 300). The mother-to-be and her doula attended two 2-hour classes about providing nonmedical, continuous support to laboring women. For the secondary study, presented here, research participants (N = 494) were interviewed by telephone using a 42-item questionnaire. RESULTS: Overall, when doula-supported mothers (n = 229) were compared with mothers who received standard care (n = 265), they were more likely to report positive prenatal expectations about childbirth and positive perceptions of their infants, support from others, and self-worth. Doula-supported mothers were also most likely to have breastfed and to have been very satisfied with the care they received at the hospital. CONCLUSIONS: Labor support by a minimally trained female friend or relative, selected by the mother-to-be, enhances the postpartum well-being of nulliparous mothers and their infants, and is a low-cost alternative to professional doulas.

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.