Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study.

BACKGROUND: Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. METHODS/DESIGN: Using a two-group, repeated measures, experimental design, we will test a 14- week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and T2DM, nutrition and exercise education, coping skills training, physical activity (Phase I), educational and motivational text messaging and 3 months of continued monthly contact (Phase II). A total of 100 African American, non-Hispanic white, and bilingual Hispanic women between 22-36 weeks of pregnancy who are diagnosed with GDM and their infants will be randomized to either the experimental group or the wait-listed control group. The first aim of the study is to determine the feasibility of the intervention. The second aim of study is to test the effects of the intervention on maternal outcomes from baseline (22-36 weeks pregnant) to 10 months postpartum. Primary maternal outcomes will include fasting blood glucose and weight (BMI) from baseline to 10 months postpartum. Secondary maternal outcomes will include clinical, adiposity, health behaviors and self-efficacy outcomes from baseline to 10 months postpartum. The third aim of the study is to quantify the effects of the intervention on infant feeding and growth. Infant outcomes will include weight status and breastfeeding from birth through 10 months of age. Data analysis will include general linear mixed-effects models. Safety endpoints include adverse event reporting. DISCUSSION: Findings from this trial may lead to an effective intervention to assist women diagnosed with GDM to improve maternal glucose homeostasis and weight as well as stabilize infant growth trajectory, reducing the burden of metabolic disease across two generations. TRIAL REGISTRATION: NCT01809431.

Postpartum glucose tolerance screening in women with gestational diabetes in the state of North Carolina.

OBJECTIVE: To determine how frequently health care providers taking care of women with gestational diabetes mellitus (GDM) are screening for postpartum glucose tolerance and what practice approaches they are using to care for women with GDM. METHODS: A mailed survey assessed health care providers' knowledge of GDM and practice patterns. Factors influencing practice protocols for measuring glucose tolerance postpartum were identified. RESULTS: Of 1,002 eligible North Carolina health professionals, 399 responded (40%); 327 of these (82%) were providing prenatal and postpartum care and returned the completed surveys. Almost all providers (98%) screen for GDM, and the majority (97%) use the 50-gram one-hour glucose challenge test. Only 27% of respondents always screen for diabetes mellitus (DM) postpartum. The most common method for screening was the 75-gram two-hour glucose tolerance test (54%). The factors most commonly associated with failure to screen were patients lost to follow-up, patient inconvenience, and inconsistent screening guidelines. A majority (59%) stated that increased reimbursement would have little to no impact on their consistency in providing diabetic counseling. CONCLUSIONS: The rate of postpartum glucose tolerance testing is low in this study of providers of postpartum care. Several modifiable barriers to screening were identified. There is a need for improved screening practices and early intervention that could help prevent the complications of DM and benefit subsequent pregnancies in this high risk population.

Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period.

OBJECTIVE: To assess why postpartum women who desired long-acting reversible contraception (LARC) did not receive it in the postpartum period and to assess which contraceptive methods they were using instead. STUDY DESIGN: This was a subgroup analysis of 324 women enrolled in a randomized, controlled trial to receive or not receive an educational LARC script during their postpartum hospitalization. Participants in this subgroup analysis stated that they were either using LARC (n = 114) or interested in using LARC (n = 210) during a follow-up survey completed after their scheduled 6-week postpartum visit. Modified Poisson regression analysis was used to assess for characteristics associated with using LARC by the time of the follow-up survey. RESULTS: Women who were interested in LARC but not using it were more likely to be multiparous (relative risk [RR], 1.59; 95% CI, 1.19-2.11) and to have missed their postpartum visit (RR, 25.88; 95% CI, 3.75-178.44) compared with those using LARC. Among the interested 210 who were not using LARC, the most common reasons provided for non-use were that they were told to come back for another insertion visit (45%), missed the postpartum visit (26%), and could not afford LARC (11%). The most common contraceptive methods used instead of LARC were barrier methods (42%) and abstinence (19%); 18% used no contraceptive method. CONCLUSION: Two-thirds (65%) of postpartum women who desired to use LARC did not receive it in the postpartum period and used less effective contraceptive methods. Increasing access to immediate postpartum LARC and eliminating two-visit protocols for LARC insertion may increase postpartum LARC use. As the Affordable Care Act moves toward full implementation, it is necessary to understand the barriers that prevent interested patients from receiving LARC.

Screening for gestational diabetes: a summary of the evidence for the U.S. Preventive Services Task Force.

OBJECTIVE: To systematically review the evidence for screening for gestational diabetes mellitus (GDM). DATA SOURCES: We established eligibility criteria for relevant studies. We systematically searched MEDLINE and the Cochrane Collaboration Library for studies meeting eligibility criteria. We supplemented this search with further studies identified from reference lists of reviews. METHODS OF STUDY SELECTION: Two reviewers examined each article for eligibility. A single reviewer abstracted relevant data from the included articles; a second reviewer checked the abstractions. We graded the quality of the articles according to criteria developed by the U.S. Preventive Services Task Force. TABULATION, INTEGRATION, AND RESULTS: No well-conducted, randomized, controlled trial provides direct evidence for the health benefits of screening for GDM. The evidence is unclear regarding the optimal screening and reference diagnostic test for GDM. The impact of hyperglycemia on adverse maternal and neonatal health outcomes is probably continuous. Although insulin therapy decreases the incidence of fetal macrosomia for those women with more severe degrees of hyperglycemia, the magnitude of any effect on maternal and neonatal health outcomes is not clear. The evidence is insufficient to determine the magnitude of health benefit for any treatment among the large number of women with GDM at milder degrees of hyperglycemia. We found limited evidence regarding the potential adverse effects of screening for GDM. CONCLUSION: Because of the lack of high-quality evidence concerning critical issues, we are unable to determine the extent to which screening has an important impact on maternal and neonatal health outcomes. A randomized, controlled trial of screening is necessary to answer the many remaining questions.

Effect of an educational script on postpartum contraceptive use: a randomized controlled trial.

OBJECTIVES: Short interpregnancy intervals are associated with adverse perinatal outcomes. Increased postpartum use of long-acting reversible contraception (LARC) could reduce short interpregnancy intervals. Therefore, the primary objective of our study was to evaluate if a postpartum educational script about LARC (LARC script) could increase postpartum LARC utilization at the 6-week postpartum visit. STUDY DESIGN: We completed a randomized controlled trial (1:1) of 800 postpartum women in Raleigh, North Carolina. Women were recruited from the postpartum unit and randomized to receive (intervention) or not receive (control) the LARC script prior to hospital discharge. We conducted follow-up phone interviews to assess LARC use after their 6-week postpartum visit. We used Pearson's chi-squared test to compare LARC use between arms. RESULTS: Between May 2011 and January 2012, 400 women were randomized to each arm. Three hundred sixty-nine women (92.3%) in each arm were successfully contacted after their 6-week postpartum visit. LARC use was reported by 17.6% and 13.3% of women in the intervention and control arms, respectively (p=.103). CONCLUSIONS: The LARC script did not increase LARC utilization at the 6-week postpartum visit. Future studies should evaluate interventions that address both educational and systematic barriers to postpartum LARC uptake. IMPLICATIONS: Use of a postpartum educational script focused on the intrauterine device and contraceptive implant did not increase their utilization after the 6-week postpartum visit. Future studies should evaluate interventions that address both educational and systematic barriers to postpartum contraceptive uptake.

Characteristics associated with interest in long-acting reversible contraception in a postpartum population.

BACKGROUND: Short interpregnancy intervals lead to adverse perinatal outcomes and could be prevented with increased use of long-acting reversible contraception (LARC) in the postpartum period. The primary objective of this study was to assess which baseline characteristics are associated with the intent to use LARC among postpartum women. STUDY DESIGN: This study was a substudy of baseline data from a randomized controlled trial. Eight hundred women completed a pre-intervention survey of demographics and reproductive health history and intentions. We estimated adjusted relative risks (RRs) of intent to use LARC for baseline characteristics of interest. RESULTS: Three hundred three postpartum women (38%) intended to use LARC. Two out of 10 baseline characteristics were significantly associated with intent to use LARC: not trying for pregnancy at time of conception [adjusted RR, 1.6; 95% confidence interval (CI), 1.2-2.1] and no desire for another pregnancy within 2 years (adjusted RR, 1.9; 95% CI, 1.2-2.8). CONCLUSIONS: High interest in LARC exists among postpartum women, particularly among women with a recent unintended pregnancy and women who do not desire pregnancy for at least 2 years. Past and future pregnancy intentions should be incorporated into future models and frameworks that evaluate postpartum contraceptive choice. Educational intervention studies are also needed to assess if LARC interest can be increased among postpartum women who are less likely to intend to use LARC but at risk for future adverse perinatal outcomes.

A randomized trial comparing vaginal misoprostol versus Foley catheter with concurrent oxytocin for labor induction in nulliparous women.

The objective of this study was to compare the efficacy and safety of intracervical Foley catheter with concurrent use of oxytocin versus vaginal misoprostol for labor induction in nulliparous women. Nulliparous women with Bishop score <6 who presented for labor induction were randomized to either 25 microg vaginal misoprostol every 4 hours followed by oxytocin, if indicated, or intracervical Foley catheter with simultaneous use of oxytocin. Among the 162 patients enrolled, 79 (49%) received misoprostol and 83 (51%) received Foley/oxytocin. We were unable to demonstrate a statistically significant difference between the misoprostol group and Foley/oxytocin group in the incidence of cesarean delivery (35% versus 29%; p = 0.37). The induction-to-delivery time was significantly shorter in the Foley/oxytocin group (18 versus 24 hours; p < 0.01). No differences in intrapartum complications, neonatal outcomes, or maternal morbidity were found. When compared with vaginal misoprostol, intracervical Foley catheter combined with oxytocin has a similar efficacy and safety profile for labor induction in nulliparous women. Foley/oxytocin results in a shorter induction-to-vaginal delivery time compared with misoprostol.

Physically abused pregnant women's perceptions about the quality of their relationships with their male partners.

OBJECTIVES: Most studies of pregnant victims of intimate partner violence have focused on the violent behaviors, without examining other potentially important dimensions of the relationships. This research studies pregnant abuse victims to examine the frequency of violent behaviors occurring during pregnancy, how women characterize the quality of their relationships, and the association between violence frequency and women's perceptions concerning the overall quality of their relationships. METHODS: Eighty-one women who were physically abused by intimate partners during pregnancy were interviewed. Information was collected concerning the women's: experiences of partner violence during pregnancy; perceptions of other aspects of the quality of their relationships; and sociodemographic characteristics. RESULTS: The most frequent type of violent behavior occurring during pregnancy was verbal aggression, followed by minor violence, and then severe violence. Men perpetrated each type of violent behavior at significantly higher rates than did their female partners. In general, the women were quite negative in their characterizations of many dimensions of their relationships, as well as in their perceptions concerning the overall quality of their relationships, with women who had been victims of more frequent violence being significantly more likely to characterize their relationships as being of lower overall quality (OR = 3.5, 95% CI = 1.4-8.7). CONCLUSIONS: Prenatal care providers are encouraged to screen their patients for intimate partner violence, and to work with others in their community to assure that women in abusive situations are offered appropriate services/interventions including safe and feasible alternatives to staying in unsatisfactory relationships with abusive partners.