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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 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]

GR-01568

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Oral contraception

Condition category

Condition code

Reproductive Health and Childbirth

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]

Lifestyle

Intervention code [2]

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]

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]

3 months (primary timepoint) and 6 months after enrollment

Primary outcome [2]

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]

3 months (primary timepoint) and 6 months after enrollment

Primary outcome [3]

Compliance of 2nd and 3rd generation OCP through a semi-structured questionnaire by one-to-one interview

Timepoint [3]

3 months (primary timepoint) and 6 months after enrollment

Secondary outcome [1]

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]

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]

Bangladesh

State/province [1]

Khulna

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Directorate General of Family Planning

Address [1]

6 Kawran Bazar Rd, Dhaka 1215

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

icddr,b Ethical Review Committee (ERC)

Ethics committee address [1]

68, Shaheed Tajuddin Ahmed Sarani

Mohakhali, Dhaka 1212, Bangladesh

Ethics committee country [1]

Bangladesh

Date submitted for ethics approval [1]

Approval date [1]

05/10/2017

Ethics approval number [1]

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

Dr Mahbub Elahi Chowdhury

Address

International Centre for Diarrhoeal Disease Research, Bangladesh
68, Shaheed Tajuddin Ahmed Sarani,
Mohakhali, Dhaka 1212, Bangladesh

Country

Bangladesh

Phone

+8801713093869

Fax

melahi@icddrb.org

Contact person for public queries

Name

Mahbub Elahi Chowdhury

Address

International Centre for Diarrhoeal Disease Research, Bangladesh
68, Shaheed Tajuddin Ahmed Sarani,
Mohakhali, Dhaka 1212, Bangladesh

Country

Bangladesh

Phone

+8801713093869

Fax

melahi@icddrb.org

Contact person for scientific queries

Name

Mahbub Elahi Chowdhury

Address

International Centre for Diarrhoeal Disease Research, Bangladesh
68, Shaheed Tajuddin Ahmed Sarani,
Mohakhali, Dhaka 1212, Bangladesh

Country

Bangladesh

Phone

+8801713093869

Fax

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

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