Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 59 for:    abortion , gynuity

Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799252
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
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.

Condition or disease
Abortion

Detailed Description:

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 582 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Doxy
Women who are prescribed a seven-day regimen of doxycycline following medical abortion
No Doxy
Women who are not prescribed antibiotics following medical abortion



Primary Outcome Measures :
  1. Incidence rates of nausea [ Time Frame: 7-14 days following medical abortion ]
    Compare the incidence rates of nausea between women who are prescribed a seven-day regimen of doxycycline to women who are not prescribed antibiotics following medical abortion

  2. adherence [ Time Frame: 7-14 days following medical abortion ]
    Document the self-reported adherence to antibiotic regimens following medical abortion


Secondary Outcome Measures :
  1. Nausea rates [ Time Frame: 7-14 days following medical abortion ]
    Compare the rates of nausea between women who take at least one doxycycline pill to women who do not take any doxycycline following medical abortion

  2. Non-nausea side effects [ Time Frame: 7-14 days following medical abortion ]
    Compare the rates of other (non-nausea) side effects between women who are prescribed a seven-day regimen of doxycycline to women who are not prescribed antibiotics following medical abortion

  3. Additional medications [ Time Frame: 7-14 days following medical abortion ]
    Compare the use of additional medication to treat side effects between women who take antibiotics and women who do not take antibiotics following medical abortion

  4. Cost [ Time Frame: at time of filling prescription ]
    Document the cost to women of antibiotics regimens following medical abortion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll 610 women. Women will be recruited from 5 clinics and will self-administer, or if necessary, a study coordinator will administer, a computer-based questionnaire 7-14 days following administration of mifepristone.
Criteria

Inclusion Criteria:

  • 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
  • In the doxycycline arm: Women who have been prescribed doxycycline

Exclusion Criteria:

  • Women who were treated with antibiotics for a medical condition unrelated to their medical abortion between the initial visit and follow-up appointment
  • Women who have previously enrolled in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799252


Locations
Layout table for location information
United States, Georgia
Feminist Women's Health Center
Atlanta, Georgia, United States, 30329
United States, Illinois
Family Planning Associates
Chicago, Illinois, United States, 60630
United States, Michigan
Planned Parenthood Mid and South Michigan
Ann Arbor, Michigan, United States, 48104
United States, Minnesota
Planned Parenthood MN, ND, SD
St. Paul, Minnesota, United States, 55114
United States, New York
Family Practice and Sidney Hillman Family Practice at the Institute for Family Health
New York, New York, United States, 10003
NYU/Bellevue Hospital Center, Women's Health Center
New York, New York, United States, 10016
United States, Washington
Cedar River Clinic
Renton, Washington, United States, 98057
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Layout table for investigator information
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01799252     History of Changes
Other Study ID Numbers: 7000
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014
Keywords provided by Gynuity Health Projects:
medical abortion
doxycycline
antibiotics
adherence
nausea
Additional relevant MeSH terms:
Layout table for MeSH terms
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents