The main purpose of the PCPPP trial was to determine if a set of systematic, coordinated, evidenced-based risk-reduction strategies implemented during the inter-conception period would reduce the risk of a subsequent PTB. We are unaware of any similar large scale RCT attempting to mitigate multiple known risk factors for repeat PTB, in a cohort of women in the immediate postpartum period following a premature delivery.
The findings presented here document the prevalence of the risk factors in the study cohort, the willingness of PCPPP enrollees to agree to receive treatment, and the extent to which women participated in the medical and other services offered as part of the PCPPP trial. As noted earlier, participation rates were calculated based on the lowest possible yet reasonable thresholds for classifying an enrollee as having `participated’. In addition, the PCPPP trial was designed to incorporate every reasonable effort to eliminate, or at least minimize all known barriers to accessing treatment or services.
Not surprisingly, given that the sample consisted of women who had just delivered prematurely, the prevalence of the risk factors in the study sample appear to be high when compared to available data for similar sociodemographic populations. Recent data available from the Centers for Disease Control (CDC) , for example, revealed that 24.7 percent of adults 30 to 34 years of age had mild to severe periodontal disease, and that rates increased markedly with age for both men and women . The presence of periodontal disease in the CDC study was established according to the CDC/American Academy of Periodontology definitions, which are not directly comparable to ours. However, using a full-mouth examination and clinical confirmation by a periodontist we found that 58.5 percent of the PCPPP intervention group had moderate to severe periodontal disease. Pocket depth is generally considered an important marker for periodontal disease and all women identified as having periodontal disease in the PCPPP trial had at least one site with pocket depth ≥4 mm. By comparison, the detailed data from the above-mentioned CDC study showed that 29.6 percent of all adults 30–34 had at least one site with pocket depth >4 mm and that rates increased markedly with age. This is consistent with the conclusion that PCPPP women had a prevalence of periodontal disease considerably higher than that in the general population of women of similar age, especially in light of the fact that the average age of the PCPPP intervention group was only 25.6.
Data from the recent National Health Interview Survey reveal that about 21 percent of women 18–44 years age are current smokers , compared to almost 40 percent reported here. With respect to the prevalence of depression, reports tend to vary considerably depending on the screening instrument used, the cut-offs used to define depression and depression severity, or whether point or period prevalence rates are in question, among other things. Hence the precise `true’ prevalence of depression among postpartum women or women of childbearing age is unclear. A systematic review of the literature by Gavin and colleagues revealed that, approximately 19 percent of new mothers suffer from some form of depression at some point during the first three months following delivery, and as many as 7 percent have been diagnosed as having suffered from major depression . In the PCPPP study a total of 471 women in the intervention group were screened for depressive symptomatology during the first 3 months postpartum; of those 237 or 29 percent were identified as being “possibly depressed” according to the Center for Epidemiological Studies of Depression Scale (CES-D). Subsequent evaluation of the “possibly depressed” group using the SCID revealed that 16 percent of the intervention group was clinically depressed, more than twice the equivalent period prevalence rate reported by Gavin and colleagues.
Urogenital tract infections screened for in the PCPPP study intervention included the more commonly reported conditions of bacterial vaginosis, chlamydia, and gonorrhea. The prevalence of these conditions in the study sample was 49, 10, and 1.7 percent, respectively, compared to 19, 2.2, and 0.24 percent reported elsewhere for young adult women or women of childbearing age in general -.
In addition to the prevalence of the risk factors targeted for intervention in the PCPPP trial we also documented the rate at which eligible women were willing to participate in the respective interventions. With the exception of the smoking intervention the overwhelming majority of women identified with other risk factors expressed the willingness to receive the appropriate treatment or services. The analysis of participation patterns revealed that eligible women availed themselves of the various PCPPP treatments and services in widely varying degrees, ranging from a high of 85 percent (for infection) to a low of 28 percent (for smoking). Approximately 2 out of every 5 women identified with low literacy levels eventually received any related services, and fewer than half of the women with confirmed periodontal disease ever had any follow-up treatments. Again, in each case, every reasonable effort was made to remove or mitigate what are the most often-cited `barriers’ to receiving health care and related services -- including full reimbursement for costs and personalized accommodations related to transportation to and from clinical sites, free childcare, flexible and convenient clinical hours, and even home visits when necessary.
Not surprisingly, in most cases, the prevalence of risk factors was significantly higher for minority as compared to white women, and for low income women, as measured by insurance status. Black women enrolled in the study, for example, were more than two times more likely than white women to have been diagnosed with a urogenital tract infection and more than two and one-half times more likely to have been diagnosed with periodontal disease. In addition, both Black and Hispanic women were significantly more likely than white women to have reported housing instability, and were also significantly more likely to have elevated rates of low literacy.
There was no evidence to suggest that minority and low income women were either more reluctant to accept or able to take advantage of medical treatments or services offered as part of the PCPPP trial. Where rates of acceptance differed to any degree they tended to be higher among minority as opposed to white women (in the case of periodontal disease and low literacy) or higher among women who were uninsured or on Medicaid, as compared to privately insured women (in the case of housing instability). Moreover, there were no significant differences in participation rates associated with either race/ethnicity or insurance status, pertaining to any of the treatments or services offered as a part of the PCPPP interventions. The absence of any meaningful relationship between these socioeconomic factors and participation rates for the PCPPP trial suggests that the strategies used to make treatments and services as accessible as possible efforts were fairly successful.
The findings presented here also highlight the possibility of widely varying participation rates pertaining to interventions or programs offering multiple health and health-related treatments and services to women in the pre- or inter-conception period. Undoubtedly, participation will vary according to the perception of the benefits to those who enroll. Many other factors, however, will likely influence participation rates across `types’ of service or treatments. Ensuring that high-risk women will be able or willing to avail themselves of multiple appropriate treatments or services during the pre- or inter-conceptional period is increasingly being recognized as necessary to reduce the risk of PTB, since the underlying cause may be the cumulative effect of exposures and conditions which predate pregnancy, and may not be detectable or adequately addressed within the gestational period ,,,. Unfortunately, the forces that motivate, enable, or inhibit women from accessing needed services outside the context of prenatal care, in the pre- or inter-conceptional period, are likely to be quite complex and are by no means fully understood. Successfully identifying the appropriate strategies for increasing access to and use of risk-reduction strategies and services may well require innovative and multi-level methodologies that match the complex nature of the problem.