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Trial registered on ANZCTR


Registration number
ACTRN12622001062718
Ethics application status
Approved
Date submitted
23/06/2022
Date registered
29/07/2022
Date last updated
29/07/2022
Date data sharing statement initially provided
29/07/2022
Date results information initially provided
29/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study to compare discontinuation, side-effects, cost-effectiveness and implementation challenges between 3rd and 2nd generation Oral Contraceptive Pill (OCP) in one upazilla in Bangladesh
Scientific title
A pilot study to compare discontinuation, side-effects, cost-effectiveness and implementation challenges between 3rd and 2nd generation Oral Contraceptive Pill (OCP) in one upazilla in Bangladesh
Secondary ID [1] 307406 0
GR-01568
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral contraception 326782 0
Condition category
Condition code
Reproductive Health and Childbirth 323999 323999 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the intervention area of this study, 3rd generation OCP (3G-OCP) was procured from a renowned pharmaceutical company, named, Renata Limited, Bangladesh, which was available in the market with the brand name ‘Desolon’. Each Desolon pill contains Desogestrel BP (0.15mg) and Ethinylestradiol BP (0.03mg). Each cycle of ‘Desolon’ comes in a strip with only 21 pills and does not contain iron tablets. To make the strip similar to the 2nd generation OCP (2G-OCP), the brand name of which is ‘Sukhi’ and is available in the National Family Planning Programme (NFPP), customization of the strips of ‘Desolon’ was done by Renata Limited by adding seven additional iron tablets (each containing Ferrus Fumerates BP 75.0 mg) for the current study.

Specific administration methodology:
a) Frequency of administration: one pill a day
b) Duration of administration: a single 4-week cycle, 6 x 4 weeks back-to-back (24 weeks total)
c) Route of administration: oral pill.
d) Strategies used to monitor adherence to the intervention: drug tablet/ blank strip return, verbal confirmation of the participants at 3-month and 6-month follow-up interviews.

Selection of intervention area and control area:
The study was conducted in two unions (one intervention and one control) of the Sarankhola sub-district of the Bagerhat district of Bangladesh where OCP discontinuation rate was high (30% during January-December, 2016). From the 4 unions of the Sarankhola upazila, the intervention area (Khontakata union) and control area (Rayenda union) was pre-determined at the discretion of the principal investigator as the geographic accessibility in these two unions was better relatively as compared to the other two and also the number of OCP acceptors was close to the expected minimum number required for this study.
Intervention code [1] 323864 0
Lifestyle
Intervention code [2] 323999 0
Treatment: Drugs
Comparator / control treatment
For the control area, Directorate General of Family Planning (DGFP), Bangladesh supplied the required number of 2nd generation OCP (2G-OCP), the brand name of which is ‘Sukhi’. Each cycle of 2G-OCP comes in a strip with 21 pills containing Levonorgestrel BP (0.15mg) and Ethinylestradiol BP (0.03 mg) and 7 pills containing Ferrus Fumerates BP (75.0 mg). The 2G-OCP is already available in the National Family Planning Programme (NFPP).

Specific administration methodology:
a) Frequency of administration: one pill a day
b) Duration of administration: a single 4-week cycle, 6 x 4 weeks back-to-back (24 weeks total)
c) Route of administration: oral pill.
d) Strategies used to monitor adherence to the intervention: drug tablet/ blank strip return, verbal confirmation of the participants at 3-month and 6-month follow-up interviews.
Control group
Active

Outcomes
Primary outcome [1] 331794 0
Information on the 2nd and 3rd generation OCP use for enrolled women was collected through a semi-structured questionnaire by one-to-one interview
Timepoint [1] 331794 0
3 months (primary timepoint) and 6 months after enrollment
Primary outcome [2] 331795 0
Side-effects of the enrolled women after taking 2nd and 3rd generation OCP through a semi-structured questionnaire by one-to-one interview

Examples of side effects: Vertigo, Nausea, Blurred vision, Excessive vomiting, Migraine, Excessive bleeding during menstruation, White discharge, Prolonged duration of menstruation, White discharge, etc.

Side effects were assessed through respondents reporting and were collected through study-specific semi-structured questionnaires.
Timepoint [2] 331795 0
3 months (primary timepoint) and 6 months after enrollment
Primary outcome [3] 331974 0
Compliance of 2nd and 3rd generation OCP through a semi-structured questionnaire by one-to-one interview
Timepoint [3] 331974 0
3 months (primary timepoint) and 6 months after enrollment
Secondary outcome [1] 411165 0
Women, who discontinued the 2nd and 3rd generation OCP use, were asked about the time of, and reasons for discontinuation through a semi-structured questionnaire by one-to-one interview
Timepoint [1] 411165 0
3 months and 6 months after enrollment

Eligibility
Key inclusion criteria
i) married women within 15 and 39 years of age; ii) not pregnant at the time of enrollment; iii) no desire for having a baby in the next 1 year, and iv) willing to use OCP as a contraceptive method for the next 6 months.
Minimum age
15 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i) lactating mothers with a less than or equal 6-months-old baby; ii) known case of hypertension; iii) BMI greater than or equal to 30; iv) migraine; v) blurring of vision; vi) varicose vein, and vii) known case of diabetes mellitus.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A quasi-experimental study
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/10/2017
Date of last participant enrolment
Anticipated
Actual
25/11/2017
Date of last data collection
Anticipated
Actual
7/06/2018
Sample size
Target
1400
Accrual to date
Final
1400
Recruitment outside Australia
Country [1] 24851 0
Bangladesh
State/province [1] 24851 0
Khulna

Funding & Sponsors
Funding source category [1] 311683 0
Government body
Name [1] 311683 0
Directorate General of Family Planning
Country [1] 311683 0
Bangladesh
Primary sponsor type
Government body
Name
Ministry of Health and Family Welfare
Address
Bangladesh Secretariat, Abdul Goni Road, Dhaka 1000
Country
Bangladesh
Secondary sponsor category [1] 313138 0
None
Name [1] 313138 0
Address [1] 313138 0
Country [1] 313138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311137 0
icddr,b Ethical Review Committee (ERC)
Ethics committee address [1] 311137 0
68, Shaheed Tajuddin Ahmed Sarani

Mohakhali, Dhaka 1212, Bangladesh
Ethics committee country [1] 311137 0
Bangladesh
Date submitted for ethics approval [1] 311137 0
Approval date [1] 311137 0
05/10/2017
Ethics approval number [1] 311137 0

Summary
Brief summary
This study aimed i) to compare the discontinuation rate along with the reasons for discontinuation of 3rd and 2nd generation OCPs ii) to document the side-effect profile and satisfaction levels for the above two types of OCPs iii) to compare the level of compliances (correct and regular use) of each of the OCP type iv) to investigate the advantages and challenges related to the distribution of 2nd and 3rd generation OCPs among the clients v) to document the opinion of the policy makers and program personnel about the importance of introducing the 3rd generation OCP in the national program vi) to assess the cost effectiveness of 3rd generation OCP than the 2nd generation OCP.
A community trial was conducted in 2 unions (one intervention and one control) of the Sarankhola upazila of Bagerhat district where OCP discontinuation rate was high (30%). The study employed both quantitative and qualitative research methods to address the objectives. Cost analysis was done for assessing the cost-effectiveness of the intervention.
In each intervention and control area, 1400 eligible women were recruited after screening, checking for the selection criteria performed by the existing family planning field workers (FWAs/FWVs). Women in the intervention group were provided with 3G-OCP and those in the control group had 2G-OCP; 2 cycles at enrolment and 2 cycles at each of the 2 follow-up visits at home by the FWAs/FWVs. All the women in both the groups were interviewed three times: at enrollment and at two subsequent follow-up visits at home at 3-months apart by the study interviewers for collecting detailed information on their OCP use related practices, side-effects, continuation status including the reasons for discontinuation when applicable.
In addition, under the qualitative component, the study conducted 6 Focus Group Discussions (FGDs) with the clients who continued and those who discontinued the OCPs in this study for their perceived satisfaction and dissatisfaction with the type of OCPs they had used. A series of in-depth interviews of the family planning field workers and their supervisors; service providers; program managers and community leaders were also conducted for their perception on advantages and challenges related to distribution of 2nd and 3rd generation OCPs to the clients. The team also documented their opinion about the need of introducing the 3rd generation OCP in the national program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120070 0
Dr Mahbub Elahi Chowdhury
Address 120070 0
International Centre for Diarrhoeal Disease Research, Bangladesh
68, Shaheed Tajuddin Ahmed Sarani,
Mohakhali, Dhaka 1212, Bangladesh
Country 120070 0
Bangladesh
Phone 120070 0
+8801713093869
Fax 120070 0
Email 120070 0
melahi@icddrb.org
Contact person for public queries
Name 120071 0
Dr Mahbub Elahi Chowdhury
Address 120071 0
International Centre for Diarrhoeal Disease Research, Bangladesh
68, Shaheed Tajuddin Ahmed Sarani,
Mohakhali, Dhaka 1212, Bangladesh
Country 120071 0
Bangladesh
Phone 120071 0
+8801713093869
Fax 120071 0
Email 120071 0
melahi@icddrb.org
Contact person for scientific queries
Name 120072 0
Dr Mahbub Elahi Chowdhury
Address 120072 0
International Centre for Diarrhoeal Disease Research, Bangladesh
68, Shaheed Tajuddin Ahmed Sarani,
Mohakhali, Dhaka 1212, Bangladesh
Country 120072 0
Bangladesh
Phone 120072 0
+8801713093869
Fax 120072 0
Email 120072 0
melahi@icddrb.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The non-identifiable participants' selected socio-demographics, use of OCP, reported side effects data, compliance and reasons for discontinuation, and timing of discontinuation data will be shared upon request.
When will data be available (start and end dates)?
Data are not publicly available. However, the detailed dataset is available with Mahbub Elahi Chowdhury (MEC), the Principal Investigator of the main study. A copy of the original data is also stored in the data archive of icddr,b. Data is available through requesting Research Administration (RA) Department of icddr,b from 17/07/2018, no end date determined.
Available to whom?
Anyone who wishes to access it after having the approval of the Research Administration (RA) Department of icddr,b.
Available for what types of analyses?
Any purpose approved by the Research Administration (RA) Department of icddr,b.
How or where can data be obtained?
Non-identifiable data can be accessible upon request subject to the approval of the Research Administration (RA) Department of icddr,b. The email address to contact for dataset is aahmed@icddrb.org (Head, Research Administration, icddr,b).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.