RCT of Supporting Nurses' Dispensing Hormonal Contraception

Introduction:Unintended pregnancies have an adverse effect on the health status of women, children and families. Pregnancies occurring within 24 months of delivery are more likely unintended and more likely complicated by fetal death, intrauterine growth retardation, preterm delivery and neonatal mortality. Accordingly, putting an interval of at least two years between pregnancies is a national and international priority and one of the primary objectives of the Nurse Family Partnership Program (NFP). Although results from clinical trials reveal that the NFP program has reduced subsequent unintended pregnancies and increased the intervals between subsequent births, analyses of NFP program data reveal opportunities for improvement, particularly through improved access to contraception. This study illustrates an approach to program improvement by giving the nurses the ability to distribute hormonal contraception to clients during home visits.

Methods: We will present preliminary findings from a five-site randomized clinical trial of adding a contraceptive dispensing component to the NFP program. We have enrolled 344 participants from August 2009 through April 2012 and have continued to follow them for up to 2 years after delivery. Inclusion criteria included English or Spanish speaking (or both), enrolled in the NFP program and 32 weeks or less gestation. We randomized participants to receive either the usual NFP care or the enhanced NFP intervention that includes contraceptive administration and distribution during home visits. The 25 NFP nurses involved in the study have offered participants a choice of combination oral contraceptives, progestin-only oral contraceptives, contraceptive patches, the contraceptive vaginal ring or a depomedroxyprogesterone injection at no cost to the participants for the entire two years after delivery.

Results:All five sites have implemented the intervention safely. Preliminary data at 6 months and 12 months post partum suggest that the intervention group is more likely to use effective contraceptive methods (defined as methods with which < 10% of women experience an accidental pregnancy during a year of typical use) compared to the usual care group. In addition, the nurses delivering the intervention have reported that the intervention is within their scope of practice and is safe and replicable as long as appropriate training, protocols and logistic support are available.

Conclusion: Adding a contraceptive distribution component to the existing NFP program is safe and feasible. Given the extent of the NFP program, this practice augmentation could improve public health outcomes by increasing the interval between births while significantly reducing the incidence of unintended pregnancy.