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

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: Completed
• Conditions: Intimate Partner Violence
• Intervention / Treatment: Behavioral: Safety behaviour promoting video; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Adoption of safety behaviours	Number of used safety behaviours	change from pregnancy to 3 months postpartum
The World Health Organisation Quality of Life Brief (WHOQOL-BREF)	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

Outcome Measure	Measure Description	Time Frame
Prevalence of Intimate Partner Violence (IPV) measured using Composite Abuse Scale (revised) - Short Form (CAS R SF)	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	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

Outcome Measure	Measure Description	Time Frame
Mode of delivery	operative delivery vs. spontaneous vaginal birth	at birth
Birth weight	neonates birthweight in grams	at birth
Initiation and early cessation of breastfeeding	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	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	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

• Sponsor: Oslo Metropolitan University
• Collaborators: University of Oslo; Norwegian University of Science and Technology; La Trobe University
• Investigators: Principal Investigator: Mirjam Lukasse, PhD, Oslo and Akershus University College

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: IPV
• Other Study ID 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