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Completed

NCT Number: NCT05774626

Injectable Contraception Cohort Study 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

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Bhu 76/10-R, Khanewal, Pubjab, Pakistan

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About this study

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:

  • 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
  • To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contraceptive usage

Behavioral

Continued use of injectable contraception, administered on a quarterly basis

Primary outcomes

  1. DMPA continuation rate

    Time frame: up to 12 months

    Participant use of DMPA measured at 3, 6 and 9 months following enrollment (providing coverage for 3 months with each dose)

Other outcomes

  1. Characteristics of women in the two study groups (DMPA-SC and DMPA-IM users)

    Time frame: At enrollment

    Demographics, contraceptive history, decision-making, reasons for choosing method, reproductive empowerment, self-confidence

  2. Family planning service provision and injectable contraceptive use experiences of women in the two study groups (DMPA-SC and DMPA-IM users)

    Time frame: Up to 12 months

    Experiences receiving family planning services and with chosen contraceptive method

Sponsors and collaborators

Lead sponsor

Jhpiego

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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