跳至主要内容
临床试验/NCT05940129
NCT05940129已完成不适用

Integrating Maternal, Fetal, Newborn or Infant Safety in Antenatal and Post-natal Care Services for Rural and Tribal Women in India

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Fetal safety as measured by occurrence of fetal loss

研究概览

简要总结

Gender-based violence (GBV) (including homicide) is one of the leading causes of maternal and child (fetus, newborn or infant) mortality and morbidity in limited resource settings such as India. This study is evaluating the feasibility, acceptability and preliminary efficacy of WC-SHE (Women and Children-Safety, Health and Empowerment) intervention developed to promote health and safety outcomes of mother and children in rural and/or tribal regions in India. The aim will be to refine, optimize and standardize the WC-SHE intervention and its added components, develop fidelity measures, conduct a feasibility and acceptability evaluation of the intervention and implementation procedures as well as examine preliminary efficacy outcomes of WC-SHE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Over 18 years of age
  • Currently pregnant
  • Experienced intimate partner and/or in-law abuse in the past
  • Residing in rural or tribal areas in India

排除标准

  • Under 18 years of age
  • Not currently pregnant
  • No experience of intimate partner and/or in law abuse
  • Not residing in rural or tribal areas in India

结局指标

主要结局

Fetal safety as measured by occurrence of fetal loss

时间窗: Post intervention up to 6 months

Fetal loss includes post-intervention occurrence of any induced abortion or miscarriage, spontaneous abortion or miscarriage, or occurrence of fetal mortality or still birth

Severity and frequency of abuse by husband and in-laws as measured by the adapted Conflict Tactics Scale (CTS2)

时间窗: Baseline, 3 months, 6 months

Severity and frequency of abuse is assessed by the adapted version of the Revised Conflict Tactics Scale . Response categories range from 0 (never) to very 7 (frequently). Higher overall scores mean more conflict. Measured at Baseline, 3 months, 6 months.

Depression as assessed by the Patient Health Questionnaire

时间窗: Baseline, 3 months, 6 months

The Patient Health Questionnaire (PHQ-9) is used to measure depression; Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression. Score range 0-27. Measured at Baseline, 3 months, 6 months.

Level of satisfaction with child's health and health-related issues as assessed by the Postpartum Quality of Life (PQOL) measure

时间窗: 6 months

Participants are asked adapted items from the child care dimension of the Postpartum Quality of Life (PQOL) measure. The response options for items range from very dissatisfied to very satisfied and frequency levels ranging from never to always. Score range 16-80, with higher scores showing better quality of life.

Number of maternal safety behaviors as assessed by the Safety Behavior Checklist

时间窗: Baseline, 3 months, 6 months

The Safety Behavior Checklist is used to measure the number of safety strategies and support services used. Measured at Baseline, 3 months, 6 months.

Uncertainty in choosing safety options as assessed by the Adapted Decisional Conflict scale

时间窗: Baseline, 3 months, 6 months

The Adapted decisional conflict scale is used to measure decisional conflict for safety. The response options ranged from strongly disagree to strongly agree, with higher scores indicating lower decisional conflict. Decisional Conflict Scale scores range from 0(no decisional conflict) to 100 (high decisional conflict). Measured at Baseline, 3 months, 6 months.

Victim empowerment related to safety as assessed by the Measure of Victim Empowerment Related to Safety (MOVERS) Scale

时间窗: Baseline, 3 months, 6 months

The MOVERS scale is a 13 item scale that measures survivor empowerment within the domain of safety. Participants respond to each item using a five-point Likert scale (from "never true" to "always true. Possible score range 13-65. Higher scores indicate higher levels of empowerment related to safety. Measured at Baseline, 3 months, 6 months.

Newborn/infant health as measured by two items developed by the study team

时间窗: 6 months

Newborn/infant health is measured by number of participants who delivered a low birth weight or pre-term child. Participants are asked if newborn was (a) a low birthweight child; and (b) child born preterm.

Probable Post Traumatic Stress Disorder (PTSD) in primary care settings

时间窗: Baseline, 3 months, 6 months

Primary Care PTSD Screen is a 5 item screen used to identify participants with probable PTSD in primary care settings. The items are rated on a binary scale (No, Yes). Score range 1-5. Higher scores indicate increased post traumatic stress symptoms. Measured at Baseline, 3 months, 6 months.

Physical health status

时间窗: Baseline, 3 months, 6 months

For self-rated physical health, participants are asked about how would they describe their health during pregnancy (or post-delivery). The response options include poor, fair and excellent with poor coded as 1, fair as 2 and excellent as 3. Measured at Baseline, 3 months, 6 months.

Newborn/infant safety as measured by self-reported items developed by the study team

时间窗: 6 months

The following items are used to measure newborn or infant safety, (a) participants are asked about concern for the child's mistreatment by the participants husband or in-laws. The response options range from never (0) to always (4). (b) Participants are asked if there is concern about harm to the child by anyone, with yes/no response options; Any incident of death of a child within few weeks post-delivery is based on participants' self-reports

次要结局

  • Resilience as assessed by the Connor Davidson Resilience Scale(Baseline, 3 and 6 months)
  • Sources of support as assessed by the Brief Perceived Social Support Questionnaire(Baseline, 3 months, 6 months)
  • Economic stress(Baseline, 3 months, 6 months)
  • Self-efficacy for safety as assessed by an item developed by study team(Baseline, 3 months, 6 months)
  • Number of Self- care behaviors as measured by the items developed by the study team(Baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验