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Completed

NCT Number: NCT02343913

Simplifying Menstrual Regulation (MR): Post Abortion Care in Pakistan

This study is an additional component of protocol 6005, titled Simplifying Menstrual Regulation (MR): Exploring the role of at-home semi-quantitative pregnancy tests for follow-up to menstrual regulation service provision in Pakistan. The study seeks to pilot a self-assessment checklist that will help women, who receive medical services for incomplete abortion, correctly identify warning signs and symptoms and determine whether to return to the clinic. The checklist can serve as a useful resource to help with the timely identification of women who need additional care and can help streamline service delivery. In addition, this study will provide important data on the role of misoprostol at varying levels of health services offering an array of treatments for incomplete abortion.

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Key information

Conditions

Medical Abortion

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bhagwal Service Delivery Clinic, Bhagwal, Chakwal, Pakistan

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Vaginal bleeding during pregnancy
  • Open cervical os.
  • No signs of severe infection, defined as at least one of the following of: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
  • No hemodynamic disturbances (pulse >110/min and systolic bp <100)

Exclusion criteria

  • Suspected to have an ectopic pregnancy
  • Unable to provide informed consent

Treatment and study plan

PAC checklist

Device

Primary outcomes

  1. Identify symptoms

    Time frame: 1 week

    Proportion of women able to use a checklist to correctly identify any signs and symptoms that warrant immediate return to the clinic and additional care

Secondary outcomes

  1. Acceptability of treatment

    Time frame: 1 week

    Proportion of women who find the treatment of 400 sublingual misoprostol for incomplete abortion acceptable and satisfactory.

  2. Uptake of contraceptive use

    Time frame: 1 week

    Proportion of women who receive a contraceptive method after receipt of 400 sublingual misoprostol

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Family Planning Association Pakistan

Registry information

Official study title

Simplifying Menstrual Regulation (MR): Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service Provision in Pakistan: Post Abortion Care (PAC)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 22, 2015
Registry last updated
Mar 3, 2015

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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