Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens

This study has been completed.
Sponsor:
Collaborator:
Anonymous
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177333
First received: September 12, 2005
Last updated: October 20, 2008
Last verified: October 2008

September 12, 2005
October 20, 2008
September 2005
May 2006   (final data collection date for primary outcome measure)
doxycycline side effects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
doxycycline side effects
Complete list of historical versions of study NCT00177333 on ClinicalTrials.gov Archive Site
  • nausea [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • other side effects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • nausea
  • vomiting
  • other side effects
Not Provided
Not Provided
 
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Abortion, Induced
  • Vomiting
Drug: Doxycycline
Not Provided
Reeves MF, Lohr PA, Harwood BJ, Creinin MD. Ultrasonographic endometrial thickness after medical and surgical management of early pregnancy failure. Obstet Gynecol. 2008 Jan;111(1):106-12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2006
May 2006   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177333
pittirb0504092
No
Matthew Reeves, MD, MPH, University of Pittssburgh
University of Pittsburgh
Anonymous
Principal Investigator: M Reeves, MD University of Pittsburgh
University of Pittsburgh
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP