Domestic Violence Enhanced Perinatal Care Program in China

NCT05388565 | Recruiting

• 1 other identifier: SVRI2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project addresses intimate partner violence (IPV) against pregnant women, which is a serious social and health issue. Pregnant women represent a particularly vulnerable population of IPV survivors in China, who have been largely underserved. There have been no interventions developed in China to prevent maternal IPV and its effects on maternal and infant health. The proposed project is the first structured IPV intervention integrated into prenatal care in China, which may have the potential to be translated into more prenatal clinics in China to prevent violence against pregnant women and improve maternal and infant health.

Conditions

Intimate Partner Violence

Outcome Measures

Primary Outcomes (4)

• Intimate Partner Violence

  The Revised Conflict Tactics Scales (CTS2) will be used to measure the frequency of violent behaviors used by the partner. Higher total scores indicate more frequent violent behaviors from the partner.

  Baseline

• Intimate Partner Violence

  The Revised Conflict Tactics Scales (CTS2) will be used to measure the frequency of violent behaviors used by the partner. Higher total scores indicate more frequent violent behaviors from the partner.

  36-40 weeks before delivery

• Intimate Partner Violence

  The Revised Conflict Tactics Scales (CTS2) will be used to measure the frequency of violent behaviors used by the partner. Higher total scores indicate more frequent violent behaviors from the partner.

  3 months postpartum (6 weeks post-intervention)

• Intimate Partner Violence

  The Revised Conflict Tactics Scales (CTS2) will be used to measure the frequency of violent behaviors used by the partner. Higher total scores indicate more frequent violent behaviors from the partner.

  6 months postpartum (18 weeks post-intervention)

Study Arms (2)

The DOVE in China Intervention Group

EXPERIMENTAL

Our intervention consists of four major components: a) information about IPV and effects on maternal and infant health, b) danger assessment, c) options and safety plan, and d) resources.

Behavioral: Domestic Violence Enhanced Perinatal Care Program

The Control Group

PLACEBO COMPARATOR

The control group will be provided with a standard of care including usual perinatal care (e.g., prenatal health education) and a list of resource information (e.g., crisis lines, local IPV, and mental health resources).

Behavioral: Standard of Care

Interventions

Domestic Violence Enhanced Perinatal Care Program BEHAVIORAL

Our intervention consists of four major components: a) information about IPV and its effects on maternal and infant health, b) danger assessment, c) options and safety plan, and d) resources.

The DOVE in China Intervention Group

Standard of Care BEHAVIORAL

Usual perinatal care (e.g., prenatal health education) and a list of resource information (e.g., crisis lines, local IPV and mental health resources)

The Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being in early pregnancy (less than 13 weeks gestation) and screened positive for IPV in the year before pregnancy or during the current pregnancy.

You may not qualify if:

• Women who are not able to read and understand Chinese.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Shandong University: collaborator
• Soochow University: collaborator

Study Sites (1)

Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Fenglin Cao, MD

CONTACT

13065093172; caofenglin2008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: February 25, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 30, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CN (1)