Official Title: “Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens”

This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D & E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study

Study Primary Completion Date: May 2006

This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D & E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.

Intervention(s) in this Clinical Trial

• Drug: Doxycycline

Primary Measures

• doxycycline side effects
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• nausea
  • Time Frame: 24 hours
    Safety Issue?: No
• vomiting
  • Time Frame: 24 hours
    Safety Issue?: No
• other side effects
  • Time Frame: 24 hours
    Safety Issue?: No

Inclusion Criteria:

• 1. Gestational age 15-23 weeks by ultrasound.
• 2. Willing and able to sign an informed consent.
• 3. Placement of cervical dilators. Dilators must be placed before giving any subject doxycycline in order to ensure that all subjects who receive doxycycline will have an abortion.
• 4. Willing to comply with the study protocol.
• 5. Age at enrollment of 18 years or more.

Exclusion Criteria:

• 1. Need for an urgent D & E. Indications for this include ruptured membranes, advanced cervical dilation, infection, and fetal demise.
• 2. Allergy to doxycycline or any tetracycline
• 3. Exposure to or treatment for gonorrhea or chlamydia within the past 90 days.
• 4. Current or recent (within the past week) use of any other antibiotic.
• 5. Prior cardiac valve surgery or cardiac valve replacement. These patients should all receive alternative antibiotics for endocarditis prophylaxis.
• 6. Active use of alcohol, heroin, or cocaine. Active use of alcohol will be defined as more than 2 drinks per day. Any use of heroin or cocaine will be considered exclusionary.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

M Reeves, MD Principal Investigator University of Pittsburgh  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177333

Study ID Number: pittirb0504092

ClinicalTrials.gov Identifier: NCT00177333

Health Authority: United States: Institutional Review Board

University of Pittsburgh Center for Family Planning Research website