Introduction to the Special Section on Global Women's Reproductive Health

We welcome you to the Journal of Women’s Health 2010 special section on global women’s reproductive health. Access to a full range of reproductive healthcare is fundamental to a woman’s ability to exercise her right to control her body, to self-efficacy, and to maintain her health as well as that of her family. In 2010, no woman should die or suffer the morbidity associated with lack of access to contraception, safe abortion, or delivery with a skilled attendant. This special section addresses these issues related to women’s reproductive health from multiple perspectives

The effect of midwifery care on rates of cesarean delivery

Objective: To examine whether changing to a midwifery-led maternity service model was associated with a lower national rate of cesarean delivery. Methods: We analyzed trends in the rate of cesarean delivery per 1000 live births between 1996 and 2010 in New Zealand. Estimates of relative increases in rate were calculated via Poisson regression for several maternal age groups over the study period. Results: Rates of cesarean delivery increased over the study period, from 156.9 per 1000 live births in 1996 to 235 per 1000 in 2010: a crude increase of 49.8%. Increasing trends were apparent in each age group, with the largest increases occurring before 2003 and relatively stable rates in the subsequent period. The smoothed estimate showed that the increase in cesarean rate across all age groups was 43.7% (95% confidence interval, 41.6–45.8) over the 15-year period. Conclusion: A national midwifery-led care model was not associated with a decreased rate of cesarean delivery but, instead, with an increase similar to that in other high-resource countries. This indicates that other factors may account for the increase. Further research is needed to examine maternity outcomes associated with different models of maternity care

Inclusion, Analysis, and Reporting of Sex and Race/Ethnicity in Clinical Trials: Have We Made Progress?

Background: The National Institutes of Health (NIH) Revitalization Act of 1993 requires that NIH-funded clinical trials include women and minorities as participants; other federal agencies have adopted similar guidelines. The objective of this study is to determine the current level of compliance with these guidelines for the inclusion, analysis, and reporting of sex and race/ethnicity in federally funded randomized controlled trials (RCTs) and to compare the current level of compliance with that from 2004, which was reported previously. Methods: RCTs published in nine prominent medical journals in 2009 were identified by PubMed search. Studies where individuals were not the unit of analysis, those begun before 1994, and those not receiving federal funding were excluded. PubMed search located 512 published articles. After exclusion of ineligible articles, 86 (17%) remained for analysis. Results: Thirty studies were sex specific. The median enrollment of women in the 56 studies that included both men and women was 37%. Seventy-five percent of the studies did not report any outcomes by sex, including 9 studies reporting <20% women enrolled. Among all 86 studies, 21% did not report sample sizes by racial and ethnic groups, and 64% did not provide any analysis by racial or ethnic groups. Only 3 studies indicated that the generalizability of their results may be limited by lack of diversity among those studied. There were no statistically significant changes in inclusion or reporting of sex or race/ethnicity when compared with 2004. Conclusions: Ensuring enhanced inclusion, analysis, and reporting of sex and race/ethnicity entails the efforts of NIH, journal editors, and the researchers themselves

he More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials

PURPOSE: The National Institutes of Health (NIH) Revitalization Act of 1993 requires NIH-funded clinical trials to include women and minorities as participants and assess outcomes by sex and race or ethnicity. The objective of this study was to investigate current levels of compliance with these guidelines for inclusion, analysis, and reporting in NIH-funded randomized controlled trials (RCTs) and compare the results with those from 2009 and 2004, which the authors reported previously. METHOD: The authors identified 782 RCTs published in 14 leading U.S. medical journals in 2015 with a PubMed search. Of those, 142 were the primary report of a NIH-funded RCT, conducted in the United States, and eligible for analysis. The authors reviewed abstract, text, and tables of each eligible study as well as any follow-up published commentary to determine compliance with NIH guidelines. RESULTS: Thirty-five studies limited enrollment to one sex. The median enrollment of women in the remaining 107 studies was 46%, but 16 (15.0%) enrolled less than 30% women. Twenty-eight of the 107 (26%) reported at least one outcome by sex or explicitly included sex as a covariate in statistical analysis. Of the 142 studies, 19 (13.4%) analyzed or reported outcomes by race or ethnicity. There were no statistically significant changes in inclusion, analysis, or reporting by sex, race, or ethnicity compared with the previous studies. CONCLUSIONS: NIH policies have not resulted in significant increases in reporting results by sex, race, or ethnicity. The authors recommend strong journal policies to increase compliance with NIH policies

Navigating the Challenges of Global Reproductive Health Research

Reproductive health research in low-resource settings poses unique and complex challenges that must be addressed to ensure that global research is conducted with strict adherence to ethical principles, offers direct benefit to the research subjects, and has the potential for adoption of positive findings to the target population. This article addresses challenges to conducting reproductive health research in low-resource settings in the following areas: (1) establishment and maintenance of global collaboration, (2) community partnerships, (3) ethical issues, including informed consent and the role of incentives, (4) staff training and development, (5) data collection and management, and (6) infrastructure and logistics. Particular attention to these challenges is important to ensure that research is culturally appropriate and methodologically sound and enhances the adoption of health-promoting behaviors. Rigorous evaluation of interventions in low-resource settings may be a cost-effective and time-efficient way to identify interventions for large-scale program replication to improve women's health