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

Pan African Clinical Trials Registry