Clinical trial NCT03397277: Promoting Safety Behaviours in Antenatal Care Using a Video
Official title: Preparing for the Worst - Promoting Safety Behaviours in Antenatal Care Among Norwegian, Pakistani and Somali Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Keywords: IPV
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian University of Science and Technology
name: La Trobe University
First posted: 2018-01-11
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adoption of safety behaviours
timeFrame: change from pregnancy to 3 months postpartum
measure: The World Health Organisation Quality of Life Brief (WHOQOL-BREF)
timeFrame: Change from pregnancy to 3 months postpartum
Secondary outcomes:
measure: Prevalence of Intimate Partner Violence (IPV) measured using Composite Abuse Scale (revised) - Short Form (CAS R SF)
timeFrame: change from pregnancy to 3 months postpartum
measure: Symptoms of depression
timeFrame: 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 outcomes:
measure: Mode of delivery
timeFrame: at birth
measure: Birth weight
timeFrame: at birth
measure: Initiation and early cessation of breastfeeding
timeFrame: approximately 3 months postpartum
measure: Method of pain relief used during labour
timeFrame: at birth
measure: birth experience
timeFrame: 3 months postpartum
Locations:
city: Askim
country: Norway
facility: Trøgstad Community Health Center
city: Flateby
country: Norway
facility: Rælingen Community Health Center
city: Halden
country: Norway
facility: Familie Hus Halden
city: Høland
country: Norway
facility: Aurskog- Høland Community Health Center
city: Jevnaker
country: Norway
facility: Jevnaker Community Health Center
city: Lillestrøm
country: Norway
facility: Lillestrøm Communicy Health Center
city: Nesoddtangen
country: Norway
facility: Nesodden Community Health Center
city: Oppegård
country: Norway
facility: Oppegård Community Health Center
city: Oslo
country: Norway
facility: Grorud Community Health Center
city: Oslo
country: Norway
facility: Bjerke Community Center
city: Oslo
country: Norway
facility: Health Centre Alna
city: Oslo
country: Norway
facility: Stovner Community Health Center
city: Rakkestad
country: Norway
facility: Rakkestad Community Health Center
city: Skedsmokorset
country: Norway
facility: Skedsmo Community Health Center
city: Ski
country: Norway
facility: Langhus
city: Ski
country: Norway
facility: Ski Community Health Center
city: Våler
country: Norway
facility: Våler Community Health Center
city: Ås
country: Norway
facility: Nordberg
city: Ås
country: Norway
facility: Ås Community Health Center
Study officials:
affiliation: Oslo and Akershus University College
name: Mirjam Lukasse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flaathen EME, Henriksen L, Smastuen MC, Schei B, Taft A, Noll J, Garnweidner-Holme L, Lukasse M. Safe Pregnancy intervention for intimate partner violence: a randomised controlled trial in Norway among culturally diverse pregnant women. BMC Pregnancy Childbirth. 2022 Feb 21;22(1):144. doi: 10.1186/s12884-022-04400-z.
citation: Walter B, Indreboe H, Lukasse M, Henriksen L, Garnweidner-Holme L. Pregnant Women's Attitudes Toward and Experiences With a Tablet Intervention to Promote Safety Behaviors in a Randomized Controlled Trial: Qualitative Study. JMIR Form Res. 2021 Jul 20;5(7):e28680. doi: 10.2196/28680.
citation: Garnweidner-Holme L, Henriksen L, Flaathen EM, Klette Bohler T, Lukasse M. Midwives' Attitudes Toward and Experience With a Tablet Intervention to Promote Safety Behaviors for Pregnant Women Reporting Intimate Partner Violence: Qualitative Study. JMIR Mhealth Uhealth. 2020 May 20;8(5):e16828. doi: 10.2196/16828.
citation: Henriksen L, Flaathen EM, Angelshaug J, Garnweidner-Holme L, Smastuen MC, Noll J, Taft A, Schei B, Lukasse M. The Safe Pregnancy study - promoting safety behaviours in antenatal care among Norwegian, Pakistani and Somali pregnant women: a study protocol for a randomized controlled trial. BMC Public Health. 2019 Jun 10;19(1):724. doi: 10.1186/s12889-019-6922-y.