Completed

Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Signs and Symptoms+1

+ Signs and Symptoms, Digestive

+ Pathological Conditions, Signs and Symptoms

+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2012
See protocol details

Summary

Principal SponsorGynuity Health Projects
Last updated: February 3, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

Medical abortion (MA) consists of administering medication, typically a combination of mifepristone and misoprostol, to induce an abortion without any invasive procedures. Early first trimester MA is effective1, highly acceptable to women, and safe. The risk of infection following medical abortion is small, at less than 1%. In rare circumstances, pelvic infection with clostridia bacteria following medical abortion has resulted in death. Since 2000, when mifepristone was registered in the United States, 8 such deaths have been recorded in the US. Following the publication of case reports of four clostridium-associated deaths after medical abortion in 2005, the reproductive health community reacted swiftly. Medical abortion protocols were altered in an effort to curb these drastic and rapidly fatal infections. Antibiotic treatment, typically a seven-day course of doxycycline, has become widespread in the United States. The effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. The experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. This study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.

Principal SponsorGynuity Health Projects
Last updated: February 3, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

582 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsNausea

Criteria

3 inclusion criteria required to participate
In the doxycycline arm: Women who have been prescribed doxycycline

Women who are having MA at the study clinic and are willing to complete a self-administered, computer-based questionnaire 7-14 days after taking mifepristone

Women who can read English or Spanish

2 exclusion criteria prevent from participating
Women who have previously enrolled in this study

Women who were treated with antibiotics for a medical condition unrelated to their medical abortion between the initial visit and follow-up appointment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Feminist Women's Health Center

Atlanta, United StatesOpen Feminist Women's Health Center in Google Maps

Family Planning Associates

Chicago, United States

Planned Parenthood Mid and South Michigan

Ann Arbor, United States

Planned Parenthood MN, ND, SD

Saint Paul, United States
Completed7 Study Centers