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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Norwegian University of Science and Technology | OTHER |
| La Trobe University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screened positive intervention video | Experimental | Safety behaviour promoting video |
|
| Screened positive control video | Sham Comparator | Pregnant women who screen positive for IPV using the AAS who are randomized into viewing the control video |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety behaviour promoting video | Behavioral | A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mode of delivery | operative delivery vs. spontaneous vaginal birth | at birth |
| Birth weight | neonates birthweight in grams | at birth |
Inclusion Criteria:
Exclusion Criteria:
Only women are pregnant so only women can be recruited to this study
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| Name | Affiliation | Role |
|---|---|---|
| Mirjam Lukasse, PhD | Oslo and Akershus University College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trøgstad Community Health Center | Askim | Norway | ||||
| Nordberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35189843 | Derived | 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. | |
| 34283023 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 29, 2017 | Dec 29, 2017 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 29, 2017 | Dec 29, 2017 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2018 | Jan 11, 2018 | ICF_003.pdf |
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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.
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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.
| Control video | Behavioral | A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy |
|
| 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. |
| 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 |
| Ås |
| Norway |
| Ås Community Health Center | Ås | 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 |
| Grorud Community Health Center | Oslo | 0905 | Norway |
| Bjerke Community 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 | Norway |
| 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. |
| 32432553 | Derived | 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. |
| 31182062 | Derived | 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. |