Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

NCT01799252 | Completed

• 1 other identifier: 7000
• Study Type: observational
• Target: 582
• Locations: 1 country
• Sites: 7

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.

Conditions

Abortion

Keywords

medical abortion; doxycycline; antibiotics; adherence; nausea

Outcome Measures

Primary Outcomes (2)

• Incidence rates of nausea

  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

  7-14 days following medical abortion

• adherence

  Document the self-reported adherence to antibiotic regimens following medical abortion

  7-14 days following medical abortion

Secondary Outcomes (4)

• Nausea rates

  7-14 days following medical abortion

• Non-nausea side effects

  7-14 days following medical abortion

• Additional medications

  7-14 days following medical abortion

• Cost

  at time of filling prescription

Study Arms (2)

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (7)

Feminist Women's Health Center

Atlanta, Georgia, 30329, United States

Location

Family Planning Associates

Chicago, Illinois, 60630, United States

Location

Planned Parenthood Mid and South Michigan

Ann Arbor, Michigan, 48104, United States

Location

Planned Parenthood MN, ND, SD

Saint Paul, Minnesota, 55114, United States

Location

Family Practice and Sidney Hillman Family Practice at the Institute for Family Health

New York, New York, 10003, United States

Location

NYU/Bellevue Hospital Center, Women's Health Center

New York, New York, 10016, United States

Location

Cedar River Clinic

Renton, Washington, 98057, United States

Location

Related Publications (1)

• Frye LJ, Chong E, Winikoff B; NCT01799252 Trial Investigators. What happens when we routinely give doxycycline to medical abortion patients? Contraception. 2015 Jan;91(1):19-24. doi: 10.1016/j.contraception.2014.09.001. Epub 2014 Sep 15.

  PMID: 25444253 DERIVED

Related Links

• Sponsor website

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: February 26, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (7)