Changes to trial information |
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Eligibility |
Age group |
15/04/2020 |
age categories added |
Adult: 19 Year-44 Year |
Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) |
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Trial Information |
Public title |
15/04/2020 |
Institutional delivery care mistakenly not added as it is in the ethical clearance letter |
EFFECTS OF HEALTH EDUCATION ON SPOUSAL KNOWLEDGE AND PARTICIPATION IN BIRTH PREPAREDNESS IN FARAFENNI REGIONAL HOSPITAL, THE GAMBIA |
EFFECTS OF HEALTH EDUCATION ON SPOUSAL KNOWLEDGE AND PARTICIPATION IN BIRTH PREPAREDNESS AND INSTITUTIONAL DELIVERY IN FARAFENNI REGIONAL HOSPITAL, THE GAMBIA |
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Trial Information |
Final no of participants |
15/04/2020 |
The targeted participants were 300. 150 participants were enrolled in the experimental group and 150 in the control. However, due the post intervention followups for the post-test, 138 participants of the experimental and 119 of the control were traced and participated in the post-test. |
257 |
300 |
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Field Name
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Funding Source |
FundingSources List |
16/04/2020 |
I though that self-funded was the same as no funding but according to the comments of the reviewer, they are not the same. |
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Dr. Haddy Tunkara Bah PI, C/O School of Medicine and Allied Health Sciences, University of the Gambia, Bah, 6324, Gambia, Self Funded, |
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Funding Source |
FundingSources List |
16/04/2020 |
Bah is changed to Banjul as the city because it was a typographical error |
Dr. Haddy Tunkara Bah PI, C/O School of Medicine and Allied Health Sciences, University of the Gambia, Bah, 6324, Gambia, Self Funded, |
Dr. Haddy Tunkara Bah PI, C/O School of Medicine and Allied Health Sciences, University of the Gambia, Banjul, 6324, Gambia, Self Funded, |
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Date
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Collaborators |
Collaborators List |
16/04/2020 |
This trial was my Ph. D thesis project work and was done under the supervision of Prof. Oknofua |
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Prof. Friday Okonufua, Ogbowo Campus, University of Benin, Benin , , Nigeria |
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Ethics |
Ethics List |
19/04/2020 |
The trial was a Ph. D Thesis Project of the PI at the University of Benin. It was required for the study to be cleared by the ethical committee in this University before submitting it for approval in The Gambia where the study was conducted |
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TRUE, Research and Ethic committee College of Basic Medical Sciences University of Benin, Ogbowo campus University of Benin, Benin, 1154, Nigeria, , 14 Jun 2017, 2348023374740, researchethics@gmail.com, 10932_11270_4737.pdf |
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Ethics |
Ethics List |
19/04/2020 |
the PI is a lecturer in the Unversity of the Gambia and submitting to this committee was a requirement |
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TRUE, University of The Gambia School of Medicine and Allied Health Sciences Research and Publication Committee, No. 2 Marina Parade Banjul, Banjul, 6453, Gambia, , 15 Sep 2017, 2202246464, ethics@utg.edu.gm, 10932_11271_4737.pdf |
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Field Name
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Reporting |
Plan to share IPD |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
No |
Yes |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
IPD description |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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Individual participant data that underlie the results reported in this trial, after deidentification (text,
tables, figures, and appendices). |
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Field Name
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Date
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Reason
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Updated Value
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Reporting |
IPD-Sharing time frame |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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From publication. No ending date. |
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Key access criteria |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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From publishing journal website and request from PI |
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Study protocol document |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report |
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Field Name
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Date
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Reason
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Reporting |
Results summary |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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There was no statistically significant difference between the demographic characteristics of participants in the intervention and comparison groups except for highest level of education attained (χ2 = 17.937, p < 0.05).
The comparison group had significantly higher mean scores on knowledge of danger signs of pregnancy, (t = 2.383, p < 0.05) and labour and delivery (t = 3.855, p < 0.01) during the pre-test than those in the intervention group. However, the participants in the intervention had substantially higher mean gains after exposure to health education, while those in the comparison group recorded irrelevant differences in mean scores between the pre- and post-tests, making their differences on all the knowledge indicators statistically significant. The health education intervention alone could significantly predict 60% (R2 = 0.596%, F (1, 255 = 376.108, p < 0.001) of the variation in knowledge on birth preparedness between the intervention and comparison groups during the post-test. Combining the health education and having a senior secondary school education (β = 0.137, p < 0.05) to the model, improved the prediction to 65% (R2 = 0.646%, F (1, 255 = 17.656, p < 0.001).
The participants in the intervention group had significantly higher mean score on level of birth preparedness (M = 4.44; SD =1.46) than those in the comparison group (M = 0.97; SD = 0.83; p < 0.001). The spouses exposed to the health education were four times more likely to participate in the birth preparedness process of their wives than those in the comparison group. The most frequently reported birth preparedness indicators were saving money and identifying transport whilst the least was blood donation.
The health education intervention was able to significantly increase the positive attitude towards spousal participation in institutional delivery care in the intervention group (F (1, 255) = 109.153, p < 0.001). |
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Field Name
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Date
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Reason
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Reporting |
Date of results summaries |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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18 Apr 2020 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Date of the first journal publication |
19/04/2020 |
Not publish yet |
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18 Apr 2020 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Results & Publication URL |
19/04/2020 |
Not publish yet |
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not publish yet |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Baseline characteristics |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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The mean age of the spouses in the intervention group was 35.9 years (SD = 9.5), and 38.2 years (SD = 11.1) for those in the comparison group. The mean gestational age of their wives at booking was 24 weeks. Sixty-four percent (n = 88) and 67% (n =80) of those from the intervention and comparison groups respectively reported that they had informal Arabic education. Most of the study participants in the intervention (n = 72, 52.2%) and comparison groups (n = 65; 54.6%) were from the urban areas. There was no statistically significant difference between the demographic characteristics of participants in the intervention and comparison groups except for the highest level of education attained (χ2 = 17.937, p < 0.05).The comparison group had significantly higher mean scores on knowledge of danger signs of pregnancy, (t = 2.383, p < 0.05) and labour, and delivery (t = 3.855, p < 0.01) during the pre-test than those in the intervention group.The total levels of birth preparedness among spouses in both the intervention and comparison groups during the pre-test were rated as poor. |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Participant flow |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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Please see attached file |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Adverse events |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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None |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Outcome measures description |
19/04/2020 |
The section because it is part of the registry requirements |
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The effect of the health education intervention on spousal knowledge and participation in birth preparedness and institutional delivery was tested using analyses of covariance (ANCOVA) and hierarchical linear regression (to control for the demographic variables). Due to the reason that the participants in the study initially were not randomly assigned to the comparison and intervention groups, analysis of covariance (ANCOVA) was used to adjust for any preexisting between-group differences not controlled for at the study's onset. ANCOVA, using the pre-test mean scores as a covariate, would help to determine whether the adjusted post-test mean scores between the two sample groupings were significantly different from another (F-value; confidence level of p < 0.05). |
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Field Name
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Date
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Updated Value
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Reporting |
Link to protocol |
19/04/2020 |
The section because it is part of the registry requirements |
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yet to be publish |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Outcome measure document |
19/04/2020 |
The section because it is part of the registry requirements |
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10932_9228_4738.pdf |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Participant flow document |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
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10932_9228_4739.pdf |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Results Available |
19/04/2020 |
It is a requirement for trial registry as outline by WHO |
No |
Yes |