Clinical trial NCT02343913: Simplifying Menstrual Regulation (MR): Post Abortion Care in Pakistan
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Family Planning Association Pakistan
First posted: 2015-01-22
Enrollment: 329
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Identify symptoms
timeFrame: 1 week
Secondary outcomes:
measure: Acceptability of treatment
timeFrame: 1 week
measure: Uptake of contraceptive use
timeFrame: 1 week
Other outcomes:
Locations:
city: Bhagwal
country: Pakistan
facility: Bhagwal Service Delivery Clinic
state: Chakwal
city: Chakumra
country: Pakistan
facility: Chakumra Service Delivery Clinic
state: Chakwal
city: Karrila
country: Pakistan
facility: Karrila Service Delivery Clinic
state: Chakwal
city: Khanpur
country: Pakistan
facility: Khanpur Service Delivery Clinic
state: Chakwal
city: BagaSher
country: Pakistan
facility: BagaSher Service Delivery Clinic
state: Muzaffargarh
city: Dasrat Colony
country: Pakistan
facility: Dasrat Colony Service Delivery Clinic
state: Muzaffargarh
city: Fazal Nagal
country: Pakistan
facility: Fazal Nagal Service Delivery Clinic
state: Muzaffargarh
city: Bahari Colony
country: Pakistan
facility: Bahari Colony Service Delivery Clinic
state: Rawalpindi
city: DhokeHasso
country: Pakistan
facility: DhokeHasso Service Delivery Clinic
state: Rawalpindi
city: Chakwal
country: Pakistan
facility: Model Clinic Chakwal
city: Faisalabad
country: Pakistan
facility: Chak 128 GB Service Delivery Clinic
city: Faisalabad
country: Pakistan
facility: Model Clinic Faisalabad
city: Islamabad
country: Pakistan
facility: Family Health Hospital
city: Lahore
country: Pakistan
facility: Family Health Hospital
city: Muzaffargarh
country: Pakistan
facility: Sabe wala clinic
Study officials:
affiliation: Gynuity Health Projects
name: Dina Abbas, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rahnuma FPAP
name: Anjum Rizvi, MBBS, MHA
role: PRINCIPAL_INVESTIGATOR
affiliation: Rahnuma FPAP
name: Asifa Khanum, MPhil, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: