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Completed

NCT Number: NCT03397277

Promoting Safety Behaviours in Antenatal Care Using a Video

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.

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Key information

Conditions

Intimate Partner Violence

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Trøgstad Community Health Center, Askim, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Safety behaviour promoting video

Behavioral

A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence

Control video

Behavioral

A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy

Primary outcomes

  1. Adoption of safety behaviours

    Time frame: change from pregnancy to 3 months postpartum

    Number of used safety behaviours

  2. 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.

Secondary outcomes

  1. 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.

  2. 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)

Other outcomes

  1. Mode of delivery

    Time frame: at birth

    operative delivery vs. spontaneous vaginal birth

  2. Birth weight

    Time frame: at birth

    neonates birthweight in grams

  3. 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

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • La Trobe University
  • Norwegian University of Science and Technology
  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2018
Registry last updated
Sep 21, 2020

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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