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

March 2, 2015 updated by: Gynuity Health Projects

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

329

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Chakwal, Pakistan
        • Model Clinic Chakwal
      • Faisalabad, Pakistan
        • Chak 128 GB Service Delivery Clinic
      • Faisalabad, Pakistan
        • Model Clinic Faisalabad
      • Islamabad, Pakistan
        • Family Health Hospital
      • Lahore, Pakistan
        • Family Health Hospital
      • Muzaffargarh, Pakistan
        • Sabe wala clinic
    • Chakwal
      • Bhagwal, Chakwal, Pakistan
        • Bhagwal Service Delivery Clinic
      • Chakumra, Chakwal, Pakistan
        • Chakumra Service Delivery Clinic
      • Karrila, Chakwal, Pakistan
        • Karrila Service Delivery Clinic
      • Khanpur, Chakwal, Pakistan
        • Khanpur Service Delivery Clinic
    • Muzaffargarh
      • BagaSher, Muzaffargarh, Pakistan
        • BagaSher Service Delivery Clinic
      • Dasrat Colony, Muzaffargarh, Pakistan
        • Dasrat Colony Service Delivery Clinic
      • Fazal Nagal, Muzaffargarh, Pakistan
        • Fazal Nagal Service Delivery Clinic
    • Rawalpindi
      • Bahari Colony, Rawalpindi, Pakistan
        • Bahari Colony Service Delivery Clinic
      • DhokeHasso, Rawalpindi, Pakistan
        • DhokeHasso Service Delivery Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAC checklist
Pictorial checklist which illustrates these signs and symptoms
Device: PAC checklist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of treatment
Time Frame: 1 week
Proportion of women who find the treatment of 400 sublingual misoprostol for incomplete abortion acceptable and satisfactory.
1 week
Uptake of contraceptive use
Time Frame: 1 week
Proportion of women who receive a contraceptive method after receipt of 400 sublingual misoprostol
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

Family Planning Association Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 6005a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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