Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202004752273171 Date of Approval: 19/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF HEALTH EDUCATION ON SPOUSAL KNOWLEDGE AND PARTICIPATION IN BIRTH PREPAREDNESS AND INSTITUTIONAL DELIVERY IN FARAFENNI REGIONAL HOSPITAL, THE GAMBIA
Official scientific title EFFECTS OF HEALTH EDUCATION ON SPOUSAL KNOWLEDGE AND PARTICIPATION IN BIRTH PREPAREDNESS IN FARAFENNI REGIONAL HOSPITAL, THE GAMBIA
Brief summary describing the background and objectives of the trial The Gambia is a male-dominant society in which husbands decide when and where their wives seek care, yet they are not involved in maternal health care services. Therefore, the purpose of this study was to design and measure the effects of antenatal health education on spousal participation in birth preparedness in Farafenni and satellite villages
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 08/09/2017
Actual trial start date 02/02/2018
Anticipated date of last follow up 31/08/2018
Actual Last follow-up date 25/01/2019
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health Education Package on obstetric danger signs birth preparedness and spousal participation The health education sessions were conducted in two separate rooms, i.e., the Antenatal Examination and the Weighing Rooms, as these rooms were not in use during the intervention days. The health education sessions were conducted by two research assistants (male and female) and the researchers using Wollof, Mandinka or Fula local languages depending on the participants’ preferences. The health education was delivered individually to all the members of the intervention group. There were two health education sessions for each of the spouses in the intervention group. First Health Education Sessions One hundred and fifty (150) spouses came for the first health education sessions, and each received a 25-minutes face-to-face health education on obstetric danger signs and birth preparedness. Posters with obstetric danger signs and birth preparedness indicators were also shown to the participants during the health talk. Counseling on blood donation was also conducted during the first health education contact with each spouse as blood donation is part of the birth preparedness process. The spouses who consented to donate blood were referred to donate blood to save for emergency during the pregnancy or delivery periods of their wives. Participants were made to understand that the blood donated may be used for other patients if their wives did not need it to avoid expiration, but the Blood Bank Unit would ensure that blood is made available to them when needed. The spouses were also informed of the expected dates of delivery of their wives so that they could make plans for it. After evaluating their comprehension and reviewing of the main messages, each participant was given a typed list of all the materials required for a clean delivery and A-4 size paper photocopies of the posters with the obstetric danger signs and birth preparedness indicator to take home. Each spouse was also informed on the date of his second session, which was at 36 weeks gestation of his wife. 6 months The antenatal booking days for pregnant women attending Farafenni Regional Hospital were Mondays, Tuesdays, and Thursdays. During these days, pregnant women whose spouses met the inclusion criteria were identified through interviews and were counseled on the purpose of the study. The women that agreed for their husbands to participate were given study participation invitation letters to deliver to them. There was no antenatal care (ANC) on Fridays, so these days were chosen as research days. The health education intervention and comparison placebo were conducted on alternate Fridays. Thirty (30) spouses were invited each Friday and were requested to come without their wives but with their antenatal cards. However, in many instances, not all the invited spouses honored the invitation to participate or to return for the second health education session. The spouses who refused to participate or to return for the second health education sessions were replaced making the health education intervention to extend for six (6) months to achieve the required sample size. The health education sessions were conducted in two separate rooms, i.e., the Antenatal Examination and the Weighing Rooms, as these rooms were not in use during the intervention days. The health education sessions were conducted by two research assistants (male and female) and the researchers using Wollof, Mandinka or Fula local languages depending on the participants’ preferences. The health education was delivered individually to all the members of the intervention group. There were two health education sessions for each of the spouses in the intervention group. 150
Control Group placebo on nutrition during pregnancy and breastfeeding counselling two counseling sessions for each participant. First session was the day of recruitment of each participant and second session at 36 weeks of individual's wife's gestation 6 months The treatment of the participants in the comparison group was similar to that of the intervention group except that they did not receive the health education messages from the intervention package but were given group counselling on nutrition during pregnancy in the first session and exclusive breast feeding in the second (duration: 45 minutes each). To avoid confusion, this group of participants was informed before the pre-test that the questions that were asked in both the pre-test and post-test were not related to the topics that were discussed in the counselling sessions. The participants from this group were not counselled or sent for blood donation. They were informed that their post-test data would be collected immediately after the deliveries of their wives. 150 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Spouses of pregnant women attending their antenatal care (ANC) booking at the Maternal and Child Clinic, Farafenni, with a gestational age between 16 to 28 weeks regardless of whether they were primp or multigravidas. 2. The spouses should come from the villages and Farafenni Wards identified as study sites and planning to stay in the area for at least one month post-delivery of their wives. 3. They should be living with their wives and expecting to be present during the pregnancy and delivery periods. 4. They should be able to speak Fula, Wollof, Mandinka or English language. 5. Permission must be given by their pregnant wives to contact them and for their participation. This due to the fact that women should be give the autonomy to choose whether their husbands can be involved in their maternal health care or not. According, WHO, despite the benefits of male partner participation in maternal health care, it should never be a requirement for women to access skilled care thus women should be empowered to make such a decision. Spouses who met the inclusion criteria but also had the following characteristic were excluded from the study: 1. Spouses less than 18 years of age during the time of data collection. This is because they had not reached the age allowed to give consent for the study as stipulated in the laws of The Gambia. 2. Spouses who were health-care professionals or studied medical sciences. 3. Spouses who were sick or traveled during the time of study participants’ enrollment. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/01/2018 The Gambia Government and Medical Research Council Joint Ethic Committee
Ethics Committee Address
Street address City Postal code Country
Fajara Banjul 2731 Gambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/06/2017 Research and Ethic committee College of Basic Medical Sciences University of Benin
Ethics Committee Address
Street address City Postal code Country
Ogbowo campus University of Benin Benin 1154 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/09/2017 University of The Gambia School of Medicine and Allied Health Sciences Research and Publication Committee
Ethics Committee Address
Street address City Postal code Country
No. 2 Marina Parade Banjul Banjul 6453 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Spousal participation in birth preparedness day of wife delivery or two to three weeks after the delivery of wife
Secondary Outcome knowledge of obstetric danger signs and birth preparedness at 36 gestation of participants wives
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Farafenni Regional Hospital Farafenni Mauritani Farafenni 6432 Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Haddy Tunkara Bah PI C/O School of Medicine and Allied Health Sciences, University of the Gambia Banjul 6324 Gambia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Haddy Tunkara Bah C/O School of Medicine and Allied Health Sciences, University of The Gambia Banjul 6324 Gambia Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Friday Okonufua Ogbowo Campus, University of Benin Benin Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haddy Tunkara Bah htbah@utg.edu.gm +2202707111 No.2 Marina parade
City Postal code Country Position/Affiliation
Banjul 6234 Gambia Lecturer University of The Gambia
Role Name Email Phone Street address
Public Enquiries Friday Okonofua feokonofua@yahoo.co.uk +234994477714 ogbowo, Benin city
City Postal code Country Position/Affiliation
Benin Nigeria University of Benin Nigeria
Role Name Email Phone Street address
Scientific Enquiries Florence Adeyemo doctoradeyemo@yahoo.com +23477646613 Ogbowo, Benin city
City Postal code Country Position/Affiliation
Benin Nigeria University of Benin
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this trial, after deidentification (text, tables, figures, and appendices). Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol From publication. No ending date. From publishing journal website and request from PI
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 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). 18/04/2020 18/04/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks yet to be publish
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
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)
Section Name Field Name Date Reason Old Value Updated Value
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
Section Name Field Name Date Reason Old Value Updated Value
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
Section Name Field Name Date Reason Old Value Updated Value
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. Dr. Haddy Tunkara Bah PI, C/O School of Medicine and Allied Health Sciences, University of the Gambia, Bah, 6324, Gambia, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
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,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 16/04/2020 This trial was my Ph. D thesis project work and was done under the supervision of Prof. Oknofua Prof. Friday Okonufua, Ogbowo Campus, University of Benin, Benin , , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
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 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
Section Name Field Name Date Reason Old Value Updated Value
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 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
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 19/04/2020 It is a requirement for trial registry as outline by WHO No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 19/04/2020 It is a requirement for trial registry as outline by WHO Individual participant data that underlie the results reported in this trial, after deidentification (text, tables, figures, and appendices).
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 19/04/2020 It is a requirement for trial registry as outline by WHO From publication. No ending date.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 19/04/2020 It is a requirement for trial registry as outline by WHO From publishing journal website and request from PI
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 19/04/2020 It is a requirement for trial registry as outline by WHO Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results summary 19/04/2020 It is a requirement for trial registry as outline by WHO 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).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of results summaries 19/04/2020 It is a requirement for trial registry as outline by WHO 18 Apr 2020
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 19/04/2020 Not publish yet 18 Apr 2020
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 19/04/2020 Not publish yet not publish yet
Section Name Field Name Date Reason Old Value Updated Value
Reporting Baseline characteristics 19/04/2020 It is a requirement for trial registry as outline by WHO 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 Field Name Date Reason Old Value Updated Value
Reporting Participant flow 19/04/2020 It is a requirement for trial registry as outline by WHO Please see attached file
Section Name Field Name Date Reason Old Value Updated Value
Reporting Adverse events 19/04/2020 It is a requirement for trial registry as outline by WHO None
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measures description 19/04/2020 The section because it is part of the registry requirements 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).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 19/04/2020 The section because it is part of the registry requirements yet to be publish
Section Name Field Name Date Reason Old Value Updated Value
Reporting Outcome measure document 19/04/2020 The section because it is part of the registry requirements 10932_9228_4738.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Participant flow document 19/04/2020 It is a requirement for trial registry as outline by WHO 10932_9228_4739.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 19/04/2020 It is a requirement for trial registry as outline by WHO No Yes