Domestic ViolenceNCT05199935
Testing the Effectiveness of a Safety-promoting Intervention in Antenatal Care
A study testing Video in people with Domestic Violence, run by Norwegian University of Science and Technology at 2 sites in Nepal.
Trial summary
Domestic violence during pregnancy can directly or indirectly cause maternal and fetal morbidity and even mortality. The investigators have validated the Abuse Assessment Screen to the Nepali context for use with a color-coded audio computer assisted self-interview method among pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,230 participants
- Where
- 2 sitesNepal
- Study dates
- 29 Jan 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 12 to 20 weeks gestational age of pregnancy
Who cannot join
- prior 12 weeks gestation
- after 20 weeks of pregnancy
- mentally unable to participate
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing the Effectiveness of a Safety-promoting Intervention With Standard Antenatal Care for Pregnant Women in Nepal
Domestic violence during pregnancy can directly or indirectly cause maternal and fetal morbidity and even mortality. The investigators have validated the Abuse Assessment Screen to the Nepali context for use with a color-coded audio computer assisted self-interview method among pregnant women. This instrument will be used to identify women experiencing domestic violence during or shortly prior to their current pregnancy. In addition, an intervention video was developed. The aim of the video is to encourage women to take safety actions, in particular telling someone about the violence experienced. Women in the control group will watch a video on a healthy pregnancy and sign and symptoms of complications and what to to if these occur.The control video was chosen to increase blinding. This study aims to investigate the effect of the video compared to an intervention video.
Read the detailed description
This randomized controlled study is a two armed study, which will take place at two locations in Nepal. Eligible women will be invited to the study when attending routine antenatal care. Women agreeing to participate will be invited to first complete a questionnaire. Upon completion of this first questionnaire women will view either the intervention or control video, irrespective of their Domestic Violence (DV) Status. In the intervention arm all women will be shown the intervention video, irrespective of their DV status. In the control arm women view an intervention video. All women are asked to return to the study during the last two months of their pregnancy. All women will be asked to complete the second questionnaire. Upon completions all women will be offered to see the intervention video. For the intervention group this will be their second viewing, for the control group this will be the first viewing of the intervention video. All women will be followed up til birth. Data about their birth will be collected from their hospital records.
- Conditions
- Domestic Violence
- Being tested
- Video, Control
- Keywords
- Pregnancy, Nepal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
Information on violence and safety behaviors. Women are encouraged to share their experience of domestic violence with others.
ControlOther
Control video on healthy pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Are shown the intervention video after filling out baseline questionnaire Receives: Behavioral: Video |
| Control | Other | Are shown a control at Time 0, baseline and the intervention video after main outcome data is collected at Time 1 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seeking support
A single question asking women if they have told anybody about the experience of domestic violence besides the person at the personal follow-up at Time 1 (baseline)
Measured: 12 to 24 weeks after intervention
Secondary outcomes (3)
Ways of Coping Checklist
Sub-scales seeking social support, avoidance and detachment, self-blame
Measured: 12 to 24 weeks after intervention
Use of safety measures
Measures women can take to prepare for leaving or reduce violence
Measured: 12 to 24 weeks after intervention
Change in Domestic Violence status
A change in domestic violence status from reporting not any experience of any domestic violence to reporting experience of any domestic violence, or the contrasting result going from reporting the experience of any domestic violence to reporting no experience of any domestic violence.
Measured: From baseline (questionnaire nr. 1) to time 1, questionnaire number 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start29 Jan 2023
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two armed randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Kathmandu Medical College and Teaching Hospital, Kathmandu University School of Medical Sciences, University of South-Eastern Norway
- Responsible party
- Sponsor
- Investigators
- Schei Berit, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199935
- Sponsor's protocol ID
- 178092
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chalise P, Manandhar P, Infanti JJ, Campbell J, Henriksen L, Joshi SK, Koju R, Pun KD, Rishal P, Simpson MR, Skovlund E, Swahnberg K, Schei B, Lukasse M. 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. BMC Public Health. 2023 Sep 15;23(1):1794. doi: 10.1186/s12889-023-16685-6.
PubMed 37715147
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effectiveness of a Safety-promoting Intervention With Standard Antenatal Care for Pregnant Women in Nepal
- ClinicalTrials.gov ID
- NCT05199935
- Acronym / sponsor ID
- 178092
- Conditions
- Domestic Violence
- Keywords
- Pregnancy, Nepal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,230 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Kathmandu Medical College and Teaching Hospital, Kathmandu University School of Medical Sciences, University of South-Eastern Norway
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Domestic violence during pregnancy can directly or indirectly cause maternal and fetal morbidity and even mortality. The investigators have validated the Abuse Assessment Screen to the Nepali context for use with a color-coded audio computer assisted self-interview method among pregnant women. This instrument will be used to identify women experiencing domestic violence during or shortly prior to their current pregnancy. In addition, an intervention video was developed. The aim of the video is to encourage women to take safety actions, in particular telling someone about the violence experienced. Women in the control group will watch a video on a healthy pregnancy and sign and symptoms of complications and what to to if these occur.The control video was chosen to increase blinding. This study aims to investigate the effect of the video compared to an intervention video.
Detailed description
This randomized controlled study is a two armed study, which will take place at two locations in Nepal. Eligible women will be invited to the study when attending routine antenatal care. Women agreeing to participate will be invited to first complete a questionnaire. Upon completion of this first questionnaire women will view either the intervention or control video, irrespective of their Domestic Violence (DV) Status. In the intervention arm all women will be shown the intervention video, irrespective of their DV status. In the control arm women view an intervention video. All women are asked to return to the study during the last two months of their pregnancy. All women will be asked to complete the second questionnaire. Upon completions all women will be offered to see the intervention video. For the intervention group this will be their second viewing, for the control group this will be the first viewing of the intervention video. All women will be followed up til birth. Data about their birth will be collected from their hospital records.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A two armed randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: VideoAre shown the intervention video after filling out baseline questionnaire |
| Control | Other | Other: ControlAre shown a control at Time 0, baseline and the intervention video after main outcome data is collected at Time 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- between 12 to 20 weeks gestational age of pregnancy
Key exclusion criteria (3 listed)
- prior 12 weeks gestation
- after 20 weeks of pregnancy
- mentally unable to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoInformation on violence and safety behaviors. Women are encouraged to share their experience of domestic violence with others. | Behavioural | Intervention |
| ControlControl video on healthy pregnancy | Other | Control |
Primary outcome
Seeking support
Time frame: 12 to 24 weeks after intervention
A single question asking women if they have told anybody about the experience of domestic violence besides the person at the personal follow-up at Time 1 (baseline)
3 secondary outcomes
Ways of Coping Checklist
Time frame: 12 to 24 weeks after intervention
Use of safety measures
Time frame: 12 to 24 weeks after intervention
Change in Domestic Violence status
Time frame: From baseline (questionnaire nr. 1) to time 1, questionnaire number 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 37715147Chalise P, Manandhar P, Infanti JJ, Campbell J, Henriksen L, Joshi SK, Koju R, Pun KD, Rishal P, Simpson MR, Skovlund E, Swahnberg K, Schei B, Lukasse M. 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. BMC Public Health. 2023 Sep 15;23(1):1794. doi: 10.1186/s12889-023-16685-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Schei Berit, PhD principal investigator
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video in people with Domestic Violence, run by Norwegian University of Science and Technology at 2 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seeking support (time frame: 12 to 24 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.