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

NCT00177333 | Completed Phase 4

• 1 other identifier: pittirb0504092
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abortion, Induced; Vomiting

Keywords

Abortion, Induced; Doxycycline; Antibiotic Prophylaxis; Vomiting; Abortion, Therapeutic

Outcome Measures

Primary Outcomes (1)

• doxycycline side effects

  24 hours

Secondary Outcomes (3)

• nausea

  24 hours

• vomiting

  24 hours

• other side effects

  24 hours

Interventions

Doxycycline DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age 15-23 weeks by ultrasound.
• Willing and able to sign an informed consent.
• 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.
• Willing to comply with the study protocol.
• Age at enrollment of 18 years or more.

You may not qualify if:

• Need for an urgent D \& E. Indications for this include ruptured membranes, advanced cervical dilation, infection, and fetal demise.
• Allergy to doxycycline or any tetracycline
• Exposure to or treatment for gonorrhea or chlamydia within the past 90 days.
• Current or recent (within the past week) use of any other antibiotic.
• Prior cardiac valve surgery or cardiac valve replacement. These patients should all receive alternative antibiotics for endocarditis prophylaxis.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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. doi: 10.1097/01.AOG.0000296655.26362.6d.

  PMID: 18165398 DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• M Reeves, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)