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Trial record 40 of 59 for:    abortion , gynuity

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

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ClinicalTrials.gov Identifier: NCT02343913
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : March 3, 2015
Sponsor:
Collaborator:
Family Planning Association Pakistan
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Medical Abortion Device: PAC checklist Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official 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)
Study Start Date : June 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arm Intervention/treatment
Experimental: PAC checklist
Pictorial checklist which illustrates these signs and symptoms
Device: PAC checklist



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343913


Locations
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Pakistan
Bhagwal Service Delivery Clinic
Bhagwal, Chakwal, Pakistan
Chakumra Service Delivery Clinic
Chakumra, Chakwal, Pakistan
Karrila Service Delivery Clinic
Karrila, Chakwal, Pakistan
Khanpur Service Delivery Clinic
Khanpur, Chakwal, Pakistan
BagaSher Service Delivery Clinic
BagaSher, Muzaffargarh, Pakistan
Dasrat Colony Service Delivery Clinic
Dasrat Colony, Muzaffargarh, Pakistan
Fazal Nagal Service Delivery Clinic
Fazal Nagal, Muzaffargarh, Pakistan
Bahari Colony Service Delivery Clinic
Bahari Colony, Rawalpindi, Pakistan
DhokeHasso Service Delivery Clinic
DhokeHasso, Rawalpindi, Pakistan
Model Clinic Chakwal
Chakwal, Pakistan
Chak 128 GB Service Delivery Clinic
Faisalabad, Pakistan
Model Clinic Faisalabad
Faisalabad, Pakistan
Family Health Hospital
Islamabad, Pakistan
Family Health Hospital
Lahore, Pakistan
Sabe wala clinic
Muzaffargarh, Pakistan
Sponsors and Collaborators
Gynuity Health Projects
Family Planning Association Pakistan
Investigators
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Principal Investigator: Dina Abbas, MPH Gynuity Health Projects
Principal Investigator: Anjum Rizvi, MBBS, MHA Rahnuma FPAP
Principal Investigator: Asifa Khanum, MPhil, MSc Rahnuma FPAP
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02343913     History of Changes
Other Study ID Numbers: 6005a
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015