Promoting Safety Behaviours in Antenatal Care Using a Video

Intimate Partner Violence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397277
• Other study ID #: 260355
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: September 2020
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 15, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

Behavioral:
• Safety behaviour promoting video
A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence
• Control video
A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Oslo Metropolitan University	La Trobe University, Norwegian University of Science and Technology, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mode of delivery	operative delivery vs. spontaneous vaginal birth	at birth
Other	Birth weight	neonates birthweight in grams	at birth
Other	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
Other	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
Other	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
Primary	Adoption of safety behaviours	Number of used safety behaviours	change from pregnancy to 3 months postpartum
Primary	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	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
Secondary	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.