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

Medical Abortion Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343913
• Other study ID #: 6005a
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: March 2, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Device:
• PAC checklist

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Family Planning Association Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Acceptability of treatment	Proportion of women who find the treatment of 400 sublingual misoprostol for incomplete abortion acceptable and satisfactory.	1 week	No
Secondary	Uptake of contraceptive use	Proportion of women who receive a contraceptive method after receipt of 400 sublingual misoprostol	1 week	No