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Promoting Safety Behaviours in Antenatal Care Using a Video

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03397277
Enrollment
250
Registered
2018-01-11
Start date
2018-01-15
Completion date
2020-09-15
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intimate Partner Violence

Keywords

IPV

Brief summary

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.

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.

Interventions

BEHAVIORALSafety behaviour promoting video

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

BEHAVIORALControl video

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

Sponsors

University of Oslo
CollaboratorOTHER
Norwegian University of Science and Technology
CollaboratorOTHER
La Trobe University
CollaboratorOTHER
Oslo Metropolitan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

All women will be shown a video (also women not screening positive for IPV). Unless staff ask women about the content of the video or the women discloses this, care providers will not know which film participants have viewed. As we include a group of women who screened negative for IPV in the assessment three months after birth care providers will not know who who screened positive and who screened negative. In the file the variable for control og intervention video will be blinded. Women will be selected for the post-partum questionnaire based on the screening for abuse. All abused women and for each abused woman two without abuse will be selected.

Intervention model description

Pregnant women will be screened for IPV using a modified version of the Abuse Assessment Screening. Women who screen positive are randomized into either the intervention video or a control video. Women screening negative for violence will be shown the control video. All women receive standard care and a card with high quality websites about safe pregnancy. Hidden among these is a webside that informs women about IPV (rights, safety etc..). Three months after birth all the women screening positive for violence will receive another questionnaire to fill out. In addition will a random sample of women who screened negative for IPV be asked to fill out a questionnaire at the same time. This group will be double the size of the women screening positive.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adoption of safety behaviourschange from pregnancy to 3 months postpartumNumber of used safety behaviours
The World Health Organisation Quality of Life Brief (WHOQOL-BREF)Change from pregnancy to 3 months postpartumA 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

MeasureTime frameDescription
Prevalence of Intimate Partner Violence (IPV) measured using Composite Abuse Scale (revised) - Short Form (CAS R SF)change from pregnancy to 3 months postpartumCAS(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.
Symptoms of depressionChange 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

MeasureTime frameDescription
Mode of deliveryat birthoperative delivery vs. spontaneous vaginal birth
birth experience3 months postpartumOne 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
Birth weightat birthneonates birthweight in grams
Initiation and early cessation of breastfeedingapproximately 3 months postpartumWe 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
Method of pain relief used during labourat birthwe 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026