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NCT Number: NCT05388565

Domestic Violence Enhanced Perinatal Care Program in China

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Fenglin Cao, PhD

CONTACT

[email protected]

13065093172

About this study

Intimate partner violence (IPV) is a serious social and health issue. It is prevalent during pregnancy and in the postpartum period, causing tremendous effects on maternal and child health such as maternal depression, preterm birth, low birth weight, and impaired child neuropsychological development. However, IPV has been overlooked and is a low priority in China. No IPV intervention and prevention program has been implemented in China to help women deal with IPV in the perinatal period and eliminate its effects on maternal and child health. The Domestic Violence Enhanced Home Visitation Program (DOVE), which is a structured IPV intervention integrated into the perinatal home visitation program in the United States, focuses on educating and empowering women about IPV and their options for preventing further IPV. Building on the demonstrated effectiveness of the DOVE intervention in preventing IPV as well as the well-established perinatal care system in China, we adapted the DOVE intervention for the context of perinatal care in China. The aim of the proposed project is to test the feasibility and acceptability of the adapted DOVE intervention ("DOVE in China") in reducing maternal IPV and infant exposure to IPV and improving maternal and child health in a sample of women recruited from two perinatal clinics located in two cities (richer vs. poorer) of China. The pilot study will use a randomized two-arm pre-posttest control group design with repeated measures and mixed methods. A total of 25 women per group, who are in early pregnancy and screened positive for IPV in the year before pregnancy or during the current pregnancy, will be recruited at each of the two perinatal clinics. The intervention group will receive three prenatal sessions and one postpartum session, while the control group will receive standard of care. The frequency of IPV, depression, perceived stress, safety behaviors, birth outcomes, and child growth and development will be assessed on the web-based survey. The phone interview will ask about women's acceptability and satisfaction with the intervention and how it impacts their well-being. All women will complete the survey at baseline, 36-40 weeks before delivery, and 3 and 6 months postpartum. The interview will be conducted with women in the intervention group immediately post-intervention. The findings will help enhance the intervention by making appropriate modifications to the processes and procedures involved and provide a foundation upon which to implement a subsequent effectiveness trial. The findings will be disseminated through various means (e.g., publications, presentations). The long-term goal is to create an integrated, sustainable model for the universal screening, assessment, and treatment of IPV in China's perinatal care and improve the health of abused women and their infants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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)

Primary outcomes

  1. Intimate Partner Violence

    Time frame: Baseline

    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.

  2. Intimate Partner Violence

    Time frame: 36-40 weeks before delivery

    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. Intimate Partner Violence

    Time frame: 3 months postpartum (6 weeks post-intervention)

    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.

  4. Intimate Partner Violence

    Time frame: 6 months postpartum (18 weeks post-intervention)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fenglin Cao, MD

CONTACT

[email protected]

13065093172

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Shandong University
  • Soochow University

Registry information

Official study title

Testing the Domestic Violence Enhanced Perinatal Care in China

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 24, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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