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OpenTrials
Completed

NCT Number: NCT01799252

Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Feminist Women's Health Center, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2013
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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