Background Prior research from India demonstrates a need for family planning counseling that engages both women and men, offers complete family planning method mix, and focuses on gender equity and reduces marital sexual violence (MSV) to promote modern contraceptive use. Effectiveness of the three-session (two male-only sessions and one couple session) Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention, which used male health providers to engage and counsel husbands on gender equity and family planning (GE + FP), was demonstrated by increased pill and condom use and a reduction in MSV. However, the intervention had limited reach to women and was therefore unable to expand access to highly effective long acting reversible contraceptives such as the intrauterine device (IUD). We developed a second iteration of the intervention, CHARM2, which retains the three sessions from the original CHARM but adds female provider- delivered counseling to women and offers a broader array of contraceptives including IUDs. This protocol describes the evaluation of CHARM2 in rural Maharashtra. Methods A two-arm cluster randomized controlled trial will evaluate CHARM2, a gender synchronized GE + FP intervention. Eligible married couples ( n = 1200) will be enrolled across 20 clusters in rural Maharashtra, India. Health providers will be gender-matched to deliver two GE + FP sessions to the married couples in parallel, and then a final session will be delivered to the couple together. We will conduct surveys on demographics as well as GE and FP indicators at baseline, 9-month, and 18-month follow-ups with both men and women, and pregnancy tests at each time point from women. In-depth interviews will be conducted with a subsample of couples ( n = 50) and providers ( n = 20). We will conduct several implementation and monitoring activities for purposes of assuring fidelity to intervention design and quality of implementation, including recruitment and tracking logs, provider evaluation forms, session observation forms, and participant satisfaction surveys. Discussion We will complete the recruitment of participants and collection of baseline data by July 2019. Findings from this work will offer important insight for the expansion of the national family planning program and improving quality of care for India and family planning interventions globally. Trial registration ClinicalTrial.gov, NCT03514914 .

Background: This study aims to explore the potential association between unintended pregnancy and maternal health complications. Secondarily, we test whether antenatal care (ANC) and community health worker (CHW) visits moderate the observed association between unintended pregnancy and maternal health complications. Methods: Cross sectional data were collected using a multistage sampling design to identify women who had a live birth in the last 12 months across 25 highest risk districts of Uttar Pradesh (N = 3659). Participants were surveyed on demographics, unintendedness of last pregnancy, receipt of ANC clinical visits and community outreach during pregnancy, and maternal complications. Regression models described the relations between unintended pregnancy and maternal complications. To determine if receipt of ANC and CHW visits in pregnancy moderated associations between unintended pregnancy and maternal complications, we used the Mantel-Haenzel risk estimation test and stratified logistic models testing interactions of unintended pregnancy and receipt of health services to predict maternal complications. Results: Around one-fifth of the women (16.9%) reported that their previous pregnancy was unintended. Logistic regression analyses revealed that unintended pregnancy was significantly associated with maternal complicationspre-eclampsia (AOR:2.06; 95% CI:1.57-2.72), postpartum hemorrhage (AOR:1.46; 95% CI: 1.01-2.13) and postpartum pre-eclampsia (AOR:2.34; 95% CI:1.47-3.72). Results from the Mantel Haenszel test indicated that both ANC and CHW home visit in pregnancy significantly affect the association between unintended pregnancy and postpartum hemorrhage (p < 0.001). Conclusion: Unintended pregnancy is associated with increased risk for maternal health complications, but provision of ANC clinical visits and CHW home visits in pregnancy may be able to reduce potential effects of unintended pregnancy on maternal health.