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

Not Applicable

Completed

• Conditions: Medical Abortion
• Interventions: Device: PAC checklist

• Registration Number: NCT02343913
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-22
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 329

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAC checklist	PAC checklist	Pictorial checklist which illustrates these signs and symptoms

Primary Outcome Measures

Name	Time	Method
Identify symptoms	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

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

Trial Locations

Locations (14)

Bhagwal Service Delivery Clinic; 🇵🇰 Bhagwal, Chakwal, Pakistan

Chakumra Service Delivery Clinic; 🇵🇰 Chakumra, Chakwal, Pakistan

Dasrat Colony Service Delivery Clinic; 🇵🇰 Dasrat Colony, Muzaffargarh, Pakistan

Bahari Colony Service Delivery Clinic; 🇵🇰 Bahari Colony, Rawalpindi, Pakistan

Khanpur Service Delivery Clinic; 🇵🇰 Khanpur, Chakwal, Pakistan

BagaSher Service Delivery Clinic; 🇵🇰 BagaSher, Muzaffargarh, Pakistan

Fazal Nagal Service Delivery Clinic; 🇵🇰 Fazal Nagal, Muzaffargarh, Pakistan

DhokeHasso Service Delivery Clinic; 🇵🇰 DhokeHasso, Rawalpindi, Pakistan

Chak 128 GB Service Delivery Clinic; 🇵🇰 Faisalabad, Pakistan

Model Clinic Faisalabad; 🇵🇰 Faisalabad, Pakistan

Sabe wala clinic; 🇵🇰 Muzaffargarh, Pakistan

Model Clinic Chakwal; 🇵🇰 Chakwal, Pakistan

Family Health Hospital; 🇵🇰 Lahore, Pakistan

Karrila Service Delivery Clinic; 🇵🇰 Karrila, Chakwal, Pakistan