Promoting Safety Behaviours in Antenatal Care Using a Video

September 18, 2020 updated by: Mirjam Lukasse, Oslo Metropolitan University

Preparing for the Worst - Promoting Safety Behaviours in Antenatal Care Among Norwegian, Pakistani and Somali Pregnant Women

This study investigates the effect of a video which teaches 15 safety behaviours for women subject to intimate partner violence (IPV) during pregnancy. Half of the women screening positive for IPV during pregnancy will view the intervention video. The other half will view a control video.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intimate partner violence (IPV) poses a risk for the health of the woman during pregnancy also for the health of the unborn child. Pregnancy is time when nearly all women have regular contact with the healthcare system. Pregnancy is also a time during which women consider their situation and are open for change.

Healthcare staff have the opportunity to ask pregnant women if they experience IPV and need to know how to respond to women experiencing IPV. Healthcare staff can refer to other services. If staff are uncertain if referral is needed or wanted they can teach women how to increase their own safety and prepare for leaving through a number of safety promoting behaviours.The safety behaviours were originally developed in the USA to counsel women who attended a family violence unit and qualified for a protection order.

Women do not always disclose the true nature of their IPV to staff. However, they could still benefit from learning about safety promoting behaviours. Using a video for teaching allows for the use of pictures and sound and options for several languages.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Askim, Norway
        • Trøgstad Community Health Center
      • Flateby, Norway
        • Rælingen Community Health Center
      • Halden, Norway
        • Familie Hus Halden
      • Høland, Norway
        • Aurskog- Høland Community Health Center
      • Jevnaker, Norway
        • Jevnaker Community Health Center
      • Lillestrøm, Norway
        • Lillestrøm Communicy Health Center
      • Nesoddtangen, Norway
        • Nesodden Community Health Center
      • Oppegård, Norway
        • Oppegård Community Health Center
      • Oslo, Norway, 0905
        • Grorud Community Health Center
      • Oslo, Norway
        • Bjerke Community Center
      • Oslo, Norway
        • Health Centre Alna
      • Oslo, Norway
        • Stovner Community Health Center
      • Rakkestad, Norway
        • Rakkestad Community Health Center
      • Skedsmokorset, Norway
        • Skedsmo Community Health Center
      • Ski, Norway
        • Langhus
      • Ski, Norway
        • Ski Community Health Center
      • Våler, Norway
        • Våler Community Health Center
      • Ås, Norway
        • Nordberg
      • Ås, Norway
        • Ås Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women attending antenatal care at the community health center,
  • 18 years or older,
  • understanding sufficient Norwegian, Urdu, Somali or English to complete the questionnaire and understand the video.

Exclusion Criteria:

  • women who do not speak or understand the languages provided in the study (English, Urdu, Somali and Norwegian)
  • women who have never been in an adult intimate relationship
  • women who are closely attended by male partner
  • women who do not have the mental of physical capacity to answer the questionnaire.
  • women who cannot fill out the questionnaire in privacy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Screened positive intervention video
Safety behaviour promoting video
Behavioral: Safety behaviour promoting video
A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence
Sham Comparator: Screened positive control video
Pregnant women who screen positive for IPV using the AAS who are randomized into viewing the control video
Behavioral: Control video
A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adoption of safety behaviours
Time Frame: change from pregnancy to 3 months postpartum
Number of used safety behaviours
change from pregnancy to 3 months postpartum
The World Health Organisation Quality of Life Brief (WHOQOL-BREF)
Time Frame: Change from pregnancy to 3 months postpartum
A scale of 26 items assessing four dimensions of quality of life (QOL), physical, psychological, environmental and social. Low score equals low QOL. Mean scores are calculated for each domain.
Change from pregnancy to 3 months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of Intimate Partner Violence (IPV) measured using Composite Abuse Scale (revised) - Short Form (CAS R SF)
Time Frame: change from pregnancy to 3 months postpartum
CAS(R)-SF is a 15-item instrument capturing physical, sexual and psychological abuse and overall IPV. Total score ranges from 0 to 75. Low score indicates less violence. Mean total score is calculated and compared.
change from pregnancy to 3 months postpartum
Symptoms of depression
Time Frame: Change from pregnancy to 3 months postpartum. Minimum score is 0, maximum score is 15. The lower the score the fewer symptoms of depression the person has. A cut-off of 7 or more is used to indicate symptoms of depression.
Edinburgh Depression Scale -5 (short version)
Change from pregnancy to 3 months postpartum. Minimum score is 0, maximum score is 15. The lower the score the fewer symptoms of depression the person has. A cut-off of 7 or more is used to indicate symptoms of depression.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: at birth
operative delivery vs. spontaneous vaginal birth
at birth
Birth weight
Time Frame: at birth
neonates birthweight in grams
at birth
Initiation and early cessation of breastfeeding
Time Frame: approximately 3 months postpartum
We will use 3 questions developed for the Norwegian Mother and Child Cohort Study (MoBa) which recruited approx 100.000 women. These questions have been developed by nutrionalists and have been used in studies and published in relation to abuse, BMJ Open. 2015 Dec 18;5(12):e009240. doi: 10.1136/bmjopen-2015-009240. Past and recent abuse is associated with early cessation of breast feeding: results from a large prospective cohort in Norway.The questions allows for measuring the proportion of women initiating breastfeeding and how many stopped breastfeeding by the time of measurement postpartum
approximately 3 months postpartum
Method of pain relief used during labour
Time Frame: at birth
we will record the number of women in each arm who receive epidural analgesia, pudendal analgesia, used water immersion for pain relief, used nitrous oxide inhalation, used other methods.
at birth
birth experience
Time Frame: 3 months postpartum
One question asking if the birth experience was solely positive, positive with negative elements, negative with positive elements or solely negative. This question has been used in other studies and the answering options are usually dichotomised into a positive or negative birth experience
3 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo Metropolitan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
Norwegian University of Science and Technology
La Trobe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mirjam Lukasse, PhD, Oslo and Akershus University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 260355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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