A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions

Study Overview
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Brief Summary
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This study, a double blinded randomized controlled trial, is being done to compare side effects of commonly used antibiotic regimens prior to same day abortion procedures. In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks gestation) will be randomized to receive one of the three commonly used antibiotics (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior to their abortion procedure. Approximately, 30-60 mins after study drug administration, the procedure will be performed. A sub-study will be completed on 40 women who consent to endometrial sampling and to have their blood drawn.

Detailed Description
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Main Study: Women will be randomized to receive single oral doses of azithromycin 500 mg, doxycycline 200 mg, metronidazole 500 mg, or placebo. Computer-generated randomization will be used to assign participants to one of the four treatment arms. Women receiving placebo will receive antibiotic prophylaxis after completion of the study. Both the participants and the investigators will be blinded as to the treatment group. This will be accomplished by placing the study medication inside opaque gelatin capsules. We will randomize participants by assigning them to the next of the sequentially numbered sealed opaque study packets, containing the gelatin capsules with study medication inside. A second envelope will be opened after completion of all study procedure and will only say if the participant received placebo, so that additional antibiotics can be given. Participants will swallow the appropriate medication approximately 30-60 minutes prior to the surgical abortion (15-90 minutes range is acceptable). Study population will be all eligible patients undergoing surgical abortion in the first trimester at Washington Hospital Center and Planned Parenthood Metropolitan Washington. We will assess pain and side effects via written questionnaire at three different time points throughout the day, once at time of consent, before and after the procedure. Patients will be contacted within 1-2 weeks for follow-up and again pain and side effects will be assessed, as well. Sub-study: Forty (n=40) women will be recruited to undergo immediate post-procedure endometrial sampling. Sub-study patients will have a blood sample collected via venipuncture before leaving the procedure room, as well. No testing will be performed for participants receiving placebo. The primary objective is to determine if the side effects associated with individual medications are more similar to placebo than the others. The sub-study aims to explore our ability to identify bacteria within the uterine cavity. The objective is to assess the feasibility of identifying bacteria within the uterus after abortion.

Official Title
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A Randomized Controlled Trial of Three Prophylactic Antibiotic Regimens for First Trimester Surgical Abortion

Conditions
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First Trimester Abortion

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Doxycycline
* Drug: Metronidazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women in good general health. English speaking. Age 18 or over. Seeking non-urgent surgical termination of pregnancy. Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram. Exclusion Criteria: Less than 18 years of age. Early pregnancy failure or fetal demise. Poor general health that would prevent one from tolerating the medication or surgical procedure. Intolerance, allergy, or contraindication to any of the study medications. Inability to tolerate oral intake due to current nausea or vomiting. Diagnosis of hyperemesis gravidarum with current pregnancy. Need of an urgent surgical abortion. Gestational age outside of 5-13 6/7 weeks by sonogram.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azithromycin<br>500 mg of Azithromycin | Drug: Azithromycin<br>* 500 mg<br>|
| Active Comparator: Doxycycline<br>200 mg of Doxycycline | Drug: Doxycycline<br>* 200 mg<br>|
| Active Comparator: Metronidazole<br>500 mg of Metronidazole | Drug: Metronidazole<br>* 500 mg<br>|
| Placebo Comparator: Placebo<br>Inactive Ingredient | Drug: Placebo<br>* Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea Scale | Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe) | 1 Day | 
| Emesis Severity | Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe) | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scale | Pain symptoms will be collected at different time points via surveys (None, Mild, Moderate, Severe) | Day 1 | 
| Serum Antibiotic Levels | Serum antibiotic levels drawn at time of endometrial sampling in subset of patients | 3 hours | 
| Endometrial Growth | Endometrial Growth on non-selective, Staph Selective, Strep Selective, and Gram negative selective Agar | 3 Days |