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Injectable Contraception Cohort Study in Punjab, Pakistan

Continuation of Subcutaneous and Intramuscular Injectable Contraception: a Non-randomized Prospective Cohort Study in Punjab, Pakistan

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05774626
Enrollment
1009
Registered
2023-03-17
Start date
2024-01-18
Completion date
2025-06-30
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage

Keywords

injectable contraception, prospective cohort study, Pakistan

Brief summary

The aim of this study is to assess the value proposition of expanding contraceptive options available to women in Punjab, Pakistan to include subcutaneous depot medroxyprogesterone acetate (DMPA-SC). Specific objectives are: 1. To compare 12-month continuation rates for DMPA-SC and intramuscular DMPA (DMPA-IM) among married women 18- 49 years of age in two districts of Punjab, Pakistan 2. To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ. 3. To assess how well women opting for self-injection of DMPA-SC adhere to standards for commodity storage, injection timing, injection technique, and waste disposal

Detailed description

Depot medroxyprogesterone acetate (DMPA) is a highly-effective, injectable contraceptive method that requires injections every 11 to 17 weeks. It is available in both intramuscular (IM) and subcutaneous (SC) formulations, which are therapeutically equivalent and have similar safety profiles. DMPA-IM has been included in the method mix for most countries for many years. DMPA-SC is a newer formulation being added to the method mix in select settings. Studies demonstrate that self-administration of subcutaneous DMPA (DMPA-SC) outside clinical settings is safe, effective, feasible, acceptable, and can improve continuation, and a recommendation in favor of self-injected DMPA-SC is included in WHO guidelines on self-care interventions for health and well-being. The Bill and Melinda Gates Foundation is funding implementation research in multiple countries to understand how self-injection of DMPA-SC can best be introduced to specific markets to expand the contraceptive options available to women and girls, health system characteristics, the demand for self-injection when DMPA-SC is offered alongside a range of other methods, and women's and girl's ability to start and continue use. Jhpiego has received funding to conduct one of these 'market tests' in Punjab, Pakistan. The aim of this study is to assess the value proposition of expanding contraceptive options available to women in Punjab, Pakistan to include subcutaneous depot medroxyprogesterone acetate (DMPA-SC). Specific objectives are: 1. To compare 12-month continuation rates for DMPA-SC and intramuscular DMPA (DMPA-IM) among married women 18- 49 years of age in two districts of Punjab, Pakistan 2. To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ. 3. To assess how well women opting for self-injection of DMPA-SC adhere to standards for commodity storage, injection timing, injection technique, and waste disposal

Interventions

BEHAVIORALContraceptive usage

Continued use of injectable contraception, administered on a quarterly basis

Sponsors

Jhpiego
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Married women aged 18-49 years * Decide to use injectable contraception and meet WHO medical eligibility criteria for injectable use * Want to avoid pregnancy for at least 12 months * Live within study districts * Are willing to be contacted by study team members via telephone and/or in-person

Exclusion criteria

* Women under age 18 and above 49 * Unmarried women * Hope to become pregnant within next 12 months * Do not reside within study districts * Are not willing to be contacted by study team members via telephone or in-person * Lack cognitive capacity to give informed consent or complete interviews

Design outcomes

Primary

MeasureTime frameDescription
DMPA continuation rateup to 12 monthsParticipant use of DMPA measured at 3, 6 and 9 months following enrollment (providing coverage for 3 months with each dose)

Other

MeasureTime frameDescription
Characteristics of women in the two study groups (DMPA-SC and DMPA-IM users)At enrollmentDemographics, contraceptive history, decision-making, reasons for choosing method, reproductive empowerment, self-confidence
Family planning service provision and injectable contraceptive use experiences of women in the two study groups (DMPA-SC and DMPA-IM users)Up to 12 monthsExperiences receiving family planning services and with chosen contraceptive method

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026