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

NCT02343913 | Completed

• 1 other identifier: 6005a
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 15

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.

Conditions

Medical Abortion

Outcome Measures

Primary Outcomes (1)

• Identify symptoms

  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 Outcomes (2)

• Acceptability of treatment

  1 week

• Uptake of contraceptive use

  1 week

Study Arms (1)

PAC checklist

EXPERIMENTAL

Pictorial checklist which illustrates these signs and symptoms

Device: PAC checklist

Interventions

PAC checklist DEVICE

PAC checklist

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Family Planning Association Pakistan: collaborator

Study Sites (15)

Bhagwal Service Delivery Clinic

Bhagwal, Chakwal, Pakistan

Location

Chakumra Service Delivery Clinic

Chakumra, Chakwal, Pakistan

Location

Karrila Service Delivery Clinic

Karrila, Chakwal, Pakistan

Location

Khanpur Service Delivery Clinic

Khanpur, Chakwal, Pakistan

Location

Chak 128 GB Service Delivery Clinic

Faisalabad, Faisalabad, Pakistan

Location

BagaSher Service Delivery Clinic

BagaSher, Muzaffargarh, Pakistan

Location

Dasrat Colony Service Delivery Clinic

Dasrat Colony, Muzaffargarh, Pakistan

Location

Fazal Nagal Service Delivery Clinic

Fazal Nagal, Muzaffargarh, Pakistan

Location

Bahari Colony Service Delivery Clinic

Bahari Colony, Rawalpindi, Pakistan

Location

DhokeHasso Service Delivery Clinic

DhokeHasso, Rawalpindi, Pakistan

Location

Model Clinic Chakwal

Chakwal, Pakistan

Location

Model Clinic Faisalabad

Faisalabad, Pakistan

Location

Family Health Hospital

Islamabad, Pakistan

Location

Family Health Hospital

Lahore, Pakistan

Location

Sabe wala clinic

Muzaffargarh, Pakistan

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 22, 2015
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-03

Locations

PA (15)