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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Active Comparator | 500 mg of Azithromycin |
|
| Doxycycline | Active Comparator | 200 mg of Doxycycline |
|
| Metronidazole | Active Comparator | 500 mg of Metronidazole |
|
| Placebo | Placebo Comparator | Inactive Ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 500 mg |
| |
| Doxycycline |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Planned Parenthood Metropolitan Washington |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin | 500 mg of Azithromycin Azithromycin: 500 mg |
| FG001 | Doxycycline | 200 mg of Doxycycline Doxycycline: 200 mg |
| FG002 | Metronidazole | 500 mg of Metronidazole Metronidazole: 500 mg |
| FG003 | Placebo | Inactive Ingredient Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 Patients excluded for protocol violations, 2 withdrawn due to cancelled Abortion procedures, 3 withdrawn as unable to tolerate study medications.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin | 500 mg of Azithromycin Azithromycin: 500 mg |
| BG001 | Doxycycline | 200 mg of Doxycycline Doxycycline: 200 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Excluded protocol violations and patients unable to complete study, see Patient Flow |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nausea Scale | Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe) | Posted | Count of Participants | Participants | 1 Day |
|
One week
Patients involved in study were called on telephone at one week to assess for any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metronidazole | Patients receivingMetronidazole for preprocedure antibiotic | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | MedStar Washington Hospital Center | 202-877-7479 | peggy.ye@medstar.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2015 | Sep 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D004318 | Doxycycline |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Drug |
200 mg |
|
| Metronidazole | Drug | 500 mg |
|
| Placebo | Drug | Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration. |
|
| 3 hours |
| Endometrial Growth | Endometrial Growth on non-selective, Staph Selective, Strep Selective, and Gram negative selective Agar | 3 Days |
| Silver Spring |
| Maryland |
| 20910 |
| United States |
| Did not complete Procedure |
|
| Changed Mind About Procedure |
|
| Protocol Violation |
|
| BG002 | Metronidazole | 500 mg of Metronidazole Metronidazole: 500 mg |
| BG003 | Placebo | Inactive Ingredient Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Excluded protocol violations and patients unable to complete study, see Patient Flow | Count of Participants | Participants |
|
| Race (NIH/OMB) | Excluded protocol violations and patients unable to complete study, see Patient Flow | Count of Participants | Participants |
|
| BMI | Body Mass Index | Excluded protocol violations and patients unable to complete study, see Patient Flow. Unable to measure height/weight for one immobilized patient (metronidazole group) | Mean | Standard Deviation | kg/m^2 |
|
| Education | Excluded protocol violations and patients unable to complete study, see Patient Flow | Count of Participants | Participants |
|
| Parous | Excluded protocol violations and patients unable to complete study, see Patient Flow | Count of Participants | Participants |
|
| Marital Status | Excluded protocol violations and patients unable to complete study, see Patient Flow | Count of Participants | Participants |
|
| Work Status | Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers | Number | participants |
|
| Prior Abortion | Excluded protocol violations and patients unable to complete study, see Patient Flow | Count of Participants | Participants |
|
| Gestational age | at time of procedure, by ultrasound criteria | Excluded protocol violations and patients unable to complete study, see Patient Flow | Mean | Standard Deviation | days |
|
| OG003 | Placebo | Inactive Ingredient Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration. |
|
|
| Primary | Emesis Severity | Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe) | 4 Subjects failed to complete the entire post-procedure survey: 1 Azithromycin group, 2 in Metronidazole group, 1 in Placebo group | Posted | Count of Participants | Participants | 1 Day |
|
|
|
| Secondary | Pain Scale | Pain symptoms will be collected at different time points via surveys (None, Mild, Moderate, Severe) | 4 patients had incomplete post-procedure surveys: 1 in Azithromycin group, 2 in Metronidazole group, 1 in Placebo group | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Serum Antibiotic Levels | Serum antibiotic levels drawn at time of endometrial sampling in subset of patients | Subset of patients who had serum antibiotic levels drawn | Posted | Mean | Standard Deviation | mcg/mL | 3 hours |
|
|
|
| Secondary | Endometrial Growth | Endometrial Growth on non-selective, Staph Selective, Strep Selective, and Gram negative selective Agar | Subset of patients with endometrial swab cultured | Posted | Count of Participants | Participants | 3 Days |
|
|
|
| 41 |
| 1 |
| 41 |
| 0 |
| 41 |
| EG001 | Azithromycin | Patients receiving Azithromycin for preprocedure antibiotic | 0 | 46 | 0 | 46 | 0 | 46 |
| EG002 | Doxycycline | Patients receiving Doxycycline for preprocedure antibiotic | 0 | 42 | 0 | 42 | 0 | 42 |
| EG003 | Placebo | Patients receiving Placebo preprocedure | 0 | 45 | 0 | 45 | 0 | 45 |
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| Organic Chemicals |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| HS Grad or Equivalent |
|
| Some College |
|
| College Grad |
|
| Graduate School |
|
| Parous |
|
| Married |
|
| Divorced |
|
| Separated |
|
| Cohabitating |
|
|
|
|
|
|
| No |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
|
| Before Procedure |
|
|
| After Procedure |
|
|
|
| Before Procedure |
|
|
| After Procedure |
|
|
| Trypic Soy Non-Selective Agar |
|
| Mannitol Salt Agar (Staph selective) |
|
| Streptococcus Agar (Strep selective) |
|
| MacConkey Agar (gram neg selective) |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|