Clinical trial NCT01799252: Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
Official title: Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion
Keywords: medical abortion
doxycycline
antibiotics
adherence
nausea
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 582
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence rates of nausea
timeFrame: 7-14 days following medical abortion
measure: adherence
timeFrame: 7-14 days following medical abortion
Secondary outcomes:
measure: Nausea rates
timeFrame: 7-14 days following medical abortion
measure: Non-nausea side effects
timeFrame: 7-14 days following medical abortion
measure: Additional medications
timeFrame: 7-14 days following medical abortion
measure: Cost
timeFrame: at time of filling prescription
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Feminist Women's Health Center
state: Georgia
city: Chicago
country: United States
facility: Family Planning Associates
state: Illinois
city: Ann Arbor
country: United States
facility: Planned Parenthood Mid and South Michigan
state: Michigan
city: St. Paul
country: United States
facility: Planned Parenthood MN, ND, SD
state: Minnesota
city: New York
country: United States
facility: Family Practice and Sidney Hillman Family Practice at the Institute for Family Health
state: New York
city: New York
country: United States
facility: NYU/Bellevue Hospital Center, Women's Health Center
state: New York
city: Renton
country: United States
facility: Cedar River Clinic
state: Washington
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.