Doxycycline Prophylaxis at Vacuum Aspiration Trial

Endometritis Clinical Trial

— Tu Du Doxy  

Official title:

Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547170
• Other study ID #: PRO06040005
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2007
• Last updated: May 14, 2008
• Start date: January 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5 days after the abortion. Subjects will be randomized to the standard regimen or to take 200 mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will receive a 7-day course of doxycycline regardless of study group. Subjects will complete questionnaires of symptoms, including nausea and emesis in the recovery room after the procedure and at a single follow-up visit two weeks later. The primary outcome will be infection after abortion, defined below. Analyses will be performed including and excluding Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis, and other side-effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria.

1. Women seeking elective surgical abortion

2. Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound.

3. Willing and able to sign an informed consent.

4. Willing to comply with the study protocol.

5. Age at enrollment of 18 years or more.

Exclusion criteria

1. Allergy to doxycycline or any tetracycline

2. Evidence of current pelvic infection

3. Breastfeeding

4. Current or recent use (within the past 7 days) of any other antibiotic.

5. Prior cardiac valve surgery or cardiac valve replacement.

6. Active use of alcohol, heroin, or cocaine.

Post-enrollment Exclusion criteria

1) Abortion procedure not performed

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endometritis

Intervention

Drug:
• Doxycycline pre-operatively
Two capsules of Doxycycline 100 mg before vacuum aspiration Placebo "100 mg" twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)
• Doxycycline post-operatively
Two capsules of placebo "100 mg" before vacuum aspiration Doxycycline 100 mg twice daily for 5 days after vacuum aspiration (appearance of capsules is the same for both groups)

Locations

Country	Name	City	State
Vietnam	Tu Du Hospital	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Tu Du Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection		2 weeks	No
Secondary	nausea and emesis		2 weeks	No
Secondary	compliance (completion of study medication)		5 days	No