Doxycycline Prophylaxis at Vacuum Aspiration Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometritis

Intervention / Treatment
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* Drug: Doxycycline pre-operatively
* Drug: Doxycycline post-operatively


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria. Women seeking elective surgical abortion Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound. Willing and able to sign an informed consent. Willing to comply with the study protocol. Age at enrollment of 18 years or more. Exclusion criteria Allergy to doxycycline or any tetracycline Evidence of current pelvic infection Breastfeeding Current or recent use (within the past 7 days) of any other antibiotic. Prior cardiac valve surgery or cardiac valve replacement. Active use of alcohol, heroin, or cocaine. Post-enrollment Exclusion criteria 1) Abortion procedure not performed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Half of enrolled women will be randomly assigned to group 1. | Drug: Doxycycline pre-operatively<br>* 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)<br>|
| Active Comparator: 2<br>Half of enrolled women will be randomly assigned to group 2 | Drug: Doxycycline post-operatively<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea and emesis |  | 2 weeks | 
| compliance (completion of study medication) |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic infection, abortion, doxycycline