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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00547170
Other study ID # PRO06040005
Secondary ID
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


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
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