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

NCT ID: NCT02343913

Last Updated: 2015-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Medical Abortion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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PAC checklist

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Group Type EXPERIMENTAL

PAC checklist

Intervention Type DEVICE

Interventions

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PAC checklist

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Family Planning Association Pakistan

UNKNOWN

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dina Abbas, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Anjum Rizvi, MBBS, MHA

Role: PRINCIPAL_INVESTIGATOR

Rahnuma FPAP

Asifa Khanum, MPhil, MSc

Role: PRINCIPAL_INVESTIGATOR

Rahnuma FPAP

Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Bhagwal Service Delivery Clinic

Bhagwal, Chakwal, Pakistan

Site Status

Chakumra Service Delivery Clinic

Chakumra, Chakwal, Pakistan

Site Status

Karrila Service Delivery Clinic

Karrila, Chakwal, Pakistan

Site Status

Khanpur Service Delivery Clinic

Khanpur, Chakwal, Pakistan

Site Status

Chak 128 GB Service Delivery Clinic

Faisalabad, Faisalabad, Pakistan

Site Status

BagaSher Service Delivery Clinic

BagaSher, Muzaffargarh, Pakistan

Site Status

Dasrat Colony Service Delivery Clinic

Dasrat Colony, Muzaffargarh, Pakistan

Site Status

Fazal Nagal Service Delivery Clinic

Fazal Nagal, Muzaffargarh, Pakistan

Site Status

Bahari Colony Service Delivery Clinic

Bahari Colony, Rawalpindi, Pakistan

Site Status

DhokeHasso Service Delivery Clinic

DhokeHasso, Rawalpindi, Pakistan

Site Status

Model Clinic Chakwal

Chakwal, , Pakistan

Site Status

Model Clinic Faisalabad

Faisalabad, , Pakistan

Site Status

Family Health Hospital

Islamabad, , Pakistan

Site Status

Family Health Hospital

Lahore, , Pakistan

Site Status

Sabe wala clinic

Muzaffargarh, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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6005a

Identifier Type: -

Identifier Source: org_study_id

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