Addressing Domestic Violence in Antenatal Care Environments in Nepal (ADVANCE) - study protocol for a randomized controlled trial evaluating a video intervention on domestic violence among pregnant women.

BACKGROUND: Domestic violence (DV) prior to, and during pregnancy is associated with increased risks for morbidity and mortality. As pregnant women routinely attend antenatal care this environment can be used to offer support to women experiencing DV. We have developed a video intervention that focuses on the use of behavioral coping strategies, particularly regarding disclosure of DV experiences. The effectiveness of this intervention will be evaluated through a randomized controlled trial (RCT) and a concurrent process evaluation. METHODS: All pregnant women between 12-22 weeks of gestation attending routine antenatal care at two tertiary level hospitals in Nepal are invited to participate. DV is measured using the Nepalese version of the Abuse Assessment Screen (N-AAS). Additionally, we measure participants' mental health, use of coping strategies, physical activity, and food security through a Color-coded Audio Computer Assisted Self Interview (C-ACASI). Irrespective of DV status, women are randomized into the intervention or control arm using a computer-generated randomization program. The intervention arm views a short video providing information on DV, safety improving actions women can take with an emphasis on disclosing the violence to a trusted person along with utilizing helplines available in Nepal. The control group watches a video on maintaining a healthy pregnancy and when to seek healthcare. The primary outcome is the proportion of women disclosing their DV status to someone. Secondary outcomes are symptoms of anxiety and depression, coping strategies, the use of safety measures and attitudes towards acceptance of abuse. Follow-up is conducted after 32 weeks of gestation, where both the intervention and control group participants view the intervention video after completing the follow-up questionnaire. Additionally, a mixed methods process evaluation of the intervention will be carried out to explore factors influencing the acceptability of the intervention and the disclosure of DV, including a review of project documents, individual interviews, and focus group discussions with members of the research team, healthcare providers, and participants. DISCUSSION: This study will provide evidence on whether pregnant women attending regular antenatal visits can enhance their safety by disclosing their experiences of violence to a trusted person after receiving a video intervention. TRIAL REGISTRATION: The study is registered in ClinicalTrial.gov with identifier NCT05199935.

ATLANTIC DIP: simplifying the follow-up of women with previous gestational diabetes.

OBJECTIVE: Previous gestational diabetes (GDM) is associated with a significant lifetime risk of type 2 diabetes. In this study, we assessed the performance of HbA1c and fasting plasma glucose (FPG) measurements against that of 75 g oral glucose tolerance testing (OGTT) for the follow-up screening of women with previous GDM. METHODS: Two hundred and sixty-six women with previous GDM underwent the follow-up testing (mean of 2.6 years (s.d. 1.0) post-index pregnancy) using HbA1c (100%), and 75 g OGTT (89%) or FPG (11%). American Diabetes Association (ADA) criteria for abnormal glucose tolerance were used. DESIGN, COHORT STUDY, AND RESULTS: The ADA HbA1c high-risk cut-off of 39 mmol/mol yielded sensitivity of 45% (95% CI 32, 59), specificity of 84% (95% CI 78, 88), negative predictive value (NPV) of 87% (95% CI 82, 91) and positive predictive value (PPV) of 39% (95% CI 27, 52) for detecting abnormal glucose tolerance. ADA high-risk criterion for FPG of 5.6 mmol/l showed sensitivity of 80% (95% CI 66, 89), specificity of 100% (95% CI 98, 100), NPV of 96% (95% CI 92, 98) and PPV of 100% (95% CI 91, 100). Combining HbA1c ≥39 mmol/mol with FPG ≥5.6 mmol/l yielded sensitivity of 90% (95% CI 78, 96), specificity of 84% (95% CI 78, 88), NPV of 97% (95% CI 94, 99) and PPV of 56% (95% CI 45, 66). CONCLUSIONS: Combining test cut-offs of 5.6 mmol/l and HbA1c 39 mmol/mol identifies 90% of women with abnormal glucose tolerance post-GDM (mean 2.6 years (s.d.1.0) post-index pregnancy). Applying this follow-up strategy will reduce the number of OGTT tests required by 70%, will be more convenient for women and their practitioners, and is likely to lead to increased uptake of long-term retesting by these women whose risk for type 2 diabetes is substantially increased.