Trial Outcomes & Findings for A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions (NCT NCT02756403)
NCT ID: NCT02756403
Last Updated: 2022-02-11
Results Overview
Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
181 participants
Primary outcome timeframe
1 Day
Results posted on
2022-02-11
Participant Flow
Participant milestones
| Measure |
Azithromycin
500 mg of Azithromycin
Azithromycin: 500 mg
|
Doxycycline
200 mg of Doxycycline
Doxycycline: 200 mg
|
Metronidazole
500 mg of Metronidazole
Metronidazole: 500 mg
|
Placebo
Inactive Ingredient
Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
45
|
43
|
47
|
|
Overall Study
COMPLETED
|
46
|
42
|
41
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Azithromycin
500 mg of Azithromycin
Azithromycin: 500 mg
|
Doxycycline
200 mg of Doxycycline
Doxycycline: 200 mg
|
Metronidazole
500 mg of Metronidazole
Metronidazole: 500 mg
|
Placebo
Inactive Ingredient
Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
|
|---|---|---|---|---|
|
Overall Study
Unable to swallow medication
|
0
|
1
|
1
|
1
|
|
Overall Study
Did not complete Procedure
|
0
|
1
|
0
|
0
|
|
Overall Study
Changed Mind About Procedure
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Excluded protocol violations and patients unable to complete study, see Patient Flow
Baseline characteristics by cohort
| Measure |
Azithromycin
n=46 Participants
500 mg of Azithromycin
Azithromycin: 500 mg
|
Doxycycline
n=42 Participants
200 mg of Doxycycline
Doxycycline: 200 mg
|
Metronidazole
n=41 Participants
500 mg of Metronidazole
Metronidazole: 500 mg
|
Placebo
n=45 Participants
Inactive Ingredient
Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.1 years
STANDARD_DEVIATION 5.0 • n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
26.2 years
STANDARD_DEVIATION 6.4 • n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
26.5 years
STANDARD_DEVIATION 5.5 • n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
28.6 years
STANDARD_DEVIATION 6.1 • n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
26.6 years
STANDARD_DEVIATION 5.9 • n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Sex: Female, Male
Female
|
46 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
42 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
41 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
45 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
174 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Sex: Female, Male
Male
|
0 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
1 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
2 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
5 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
31 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
27 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
34 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
121 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Race (NIH/OMB)
White
|
7 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
6 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
7 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
4 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
24 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
4 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
4 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
5 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
20 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
1 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
2 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
4 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
BMI
|
27.8 kg/m^2
STANDARD_DEVIATION 6.2 • n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Unable to measure height/weight for one immobilized patient (metronidazole group)
|
27.0 kg/m^2
STANDARD_DEVIATION 7.3 • n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Unable to measure height/weight for one immobilized patient (metronidazole group)
|
29.5 kg/m^2
STANDARD_DEVIATION 8.5 • n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Unable to measure height/weight for one immobilized patient (metronidazole group)
|
29.0 kg/m^2
STANDARD_DEVIATION 7.0 • n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Unable to measure height/weight for one immobilized patient (metronidazole group)
|
28.3 kg/m^2
STANDARD_DEVIATION 7.3 • n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Unable to measure height/weight for one immobilized patient (metronidazole group)
|
|
Education
Less than High School
|
4 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
3 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
7 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Education
HS Grad or Equivalent
|
17 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
16 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
13 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
16 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
62 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Education
Some College
|
14 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
18 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
20 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
17 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
69 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Education
College Grad
|
9 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
5 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
4 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
10 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
28 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Education
Graduate School
|
2 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
3 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
1 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
2 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
8 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Parous
Nulliparous
|
21 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
17 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
10 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
17 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
65 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Parous
Parous
|
25 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
25 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
31 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
28 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
109 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Marital Status
Single
|
36 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
31 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
34 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
31 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
132 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Marital Status
Married
|
4 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
9 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
3 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
5 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
21 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Marital Status
Divorced
|
0 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
1 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
1 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
3 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
5 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Marital Status
Separated
|
0 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
0 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
2 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
2 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Marital Status
Cohabitating
|
6 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
1 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
3 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
4 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
14 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Work Status
Full Time Work
|
20 participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
19 participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
16 participants
n=40 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
23 participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
78 participants
n=172 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
|
Work Status
Part Time Work
|
8 participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
6 participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
9 participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
10 participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
33 participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
|
Work Status
Full Time Student
|
4 participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
5 participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
4 participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
4 participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
17 participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
|
Work Status
Unemployed
|
14 participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
13 participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
11 participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
6 participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
44 participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
|
Work Status
Homemaker
|
0 participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
1 participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
1 participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
1 participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
3 participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
|
Work Status
Other
|
0 participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
0 participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
0 participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
1 participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
1 participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow. Several patients indicated multiple answers
|
|
Prior Abortion
Yes
|
21 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
21 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
26 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
34 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
102 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Prior Abortion
No
|
25 Participants
n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
21 Participants
n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
15 Participants
n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
11 Participants
n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
72 Participants
n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
|
Gestational age
|
60.9 days
STANDARD_DEVIATION 16.8 • n=46 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
63.9 days
STANDARD_DEVIATION 17.1 • n=42 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
65 days
STANDARD_DEVIATION 12.2 • n=41 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
67.5 days
STANDARD_DEVIATION 15.8 • n=45 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
64.3 days
STANDARD_DEVIATION 15.7 • n=174 Participants • Excluded protocol violations and patients unable to complete study, see Patient Flow
|
PRIMARY outcome
Timeframe: 1 DayNausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe)
Outcome measures
| Measure |
Azithromycin
n=46 Participants
500 mg of Azithromycin
Azithromycin: 500 mg
|
Doxycycline
n=42 Participants
200 mg of Doxycycline
Doxycycline: 200 mg
|
Metronidazole
n=41 Participants
500 mg of Metronidazole
Metronidazole: 500 mg
|
Placebo
n=45 Participants
Inactive Ingredient
Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
|
|---|---|---|---|---|
|
Nausea Scale
Baseline · None
|
8 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
|
Nausea Scale
Baseline · Mild
|
18 Participants
|
15 Participants
|
10 Participants
|
14 Participants
|
|
Nausea Scale
Baseline · Moderate
|
13 Participants
|
11 Participants
|
20 Participants
|
16 Participants
|
|
Nausea Scale
Baseline · Severe
|
7 Participants
|
7 Participants
|
5 Participants
|
9 Participants
|
|
Nausea Scale
Before Procedure · None
|
34 Participants
|
36 Participants
|
36 Participants
|
39 Participants
|
|
Nausea Scale
Before Procedure · Moderate
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Nausea Scale
Before Procedure · Severe
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Nausea Scale
Before Procedure · Mild
|
8 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Nausea Scale
After Procedure · None
|
35 Participants
|
28 Participants
|
34 Participants
|
37 Participants
|
|
Nausea Scale
After Procedure · Mild
|
7 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
|
Nausea Scale
After Procedure · Moderate
|
4 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Nausea Scale
After Procedure · Severe
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: 4 Subjects failed to complete the entire post-procedure survey: 1 Azithromycin group, 2 in Metronidazole group, 1 in Placebo group
Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe)
Outcome measures
| Measure |
Azithromycin
n=46 Participants
500 mg of Azithromycin
Azithromycin: 500 mg
|
Doxycycline
n=42 Participants
200 mg of Doxycycline
Doxycycline: 200 mg
|
Metronidazole
n=41 Participants
500 mg of Metronidazole
Metronidazole: 500 mg
|
Placebo
n=45 Participants
Inactive Ingredient
Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
|
|---|---|---|---|---|
|
Emesis Severity
Baseline · None
|
20 Participants
|
24 Participants
|
13 Participants
|
17 Participants
|
|
Emesis Severity
Baseline · Mild
|
12 Participants
|
8 Participants
|
16 Participants
|
15 Participants
|
|
Emesis Severity
Baseline · Moderate
|
6 Participants
|
6 Participants
|
11 Participants
|
8 Participants
|
|
Emesis Severity
Baseline · Severe
|
8 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Emesis Severity
Before Procedure · None
|
43 Participants
|
42 Participants
|
41 Participants
|
44 Participants
|
|
Emesis Severity
Before Procedure · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Emesis Severity
Before Procedure · Moderate
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Emesis Severity
Before Procedure · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Emesis Severity
After Procedure · None
|
42 Participants
|
35 Participants
|
39 Participants
|
44 Participants
|
|
Emesis Severity
After Procedure · Mild
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Emesis Severity
After Procedure · Moderate
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Emesis Severity
After Procedure · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: 4 patients had incomplete post-procedure surveys: 1 in Azithromycin group, 2 in Metronidazole group, 1 in Placebo group
Pain symptoms will be collected at different time points via surveys (None, Mild, Moderate, Severe)
Outcome measures
| Measure |
Azithromycin
n=46 Participants
500 mg of Azithromycin
Azithromycin: 500 mg
|
Doxycycline
n=42 Participants
200 mg of Doxycycline
Doxycycline: 200 mg
|
Metronidazole
n=41 Participants
500 mg of Metronidazole
Metronidazole: 500 mg
|
Placebo
n=45 Participants
Inactive Ingredient
Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
|
|---|---|---|---|---|
|
Pain Scale
Baseline Pain · None
|
20 Participants
|
17 Participants
|
16 Participants
|
13 Participants
|
|
Pain Scale
After Procedure · Mild
|
18 Participants
|
17 Participants
|
17 Participants
|
16 Participants
|
|
Pain Scale
Baseline Pain · Mild
|
18 Participants
|
14 Participants
|
16 Participants
|
18 Participants
|
|
Pain Scale
Baseline Pain · Moderate
|
6 Participants
|
8 Participants
|
6 Participants
|
11 Participants
|
|
Pain Scale
Baseline Pain · Severe
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Pain Scale
Before Procedure · None
|
35 Participants
|
38 Participants
|
35 Participants
|
39 Participants
|
|
Pain Scale
Before Procedure · Mild
|
9 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Pain Scale
Before Procedure · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Pain Scale
Before Procedure · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pain Scale
After Procedure · None
|
18 Participants
|
16 Participants
|
9 Participants
|
15 Participants
|
|
Pain Scale
After Procedure · Moderate
|
6 Participants
|
7 Participants
|
12 Participants
|
11 Participants
|
|
Pain Scale
After Procedure · Severe
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 hoursPopulation: Subset of patients who had serum antibiotic levels drawn
Serum antibiotic levels drawn at time of endometrial sampling in subset of patients
Outcome measures
| Measure |
Azithromycin
n=5 Participants
500 mg of Azithromycin
Azithromycin: 500 mg
|
Doxycycline
n=6 Participants
200 mg of Doxycycline
Doxycycline: 200 mg
|
Metronidazole
n=8 Participants
500 mg of Metronidazole
Metronidazole: 500 mg
|
Placebo
Inactive Ingredient
Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
|
|---|---|---|---|---|
|
Serum Antibiotic Levels
|
0.41 mcg/mL
Standard Deviation 0.22
|
1.1 mcg/mL
Standard Deviation 0.8
|
8.2 mcg/mL
Standard Deviation 3.8
|
—
|
SECONDARY outcome
Timeframe: 3 DaysPopulation: Subset of patients with endometrial swab cultured
Endometrial Growth on non-selective, Staph Selective, Strep Selective, and Gram negative selective Agar
Outcome measures
| Measure |
Azithromycin
n=7 Participants
500 mg of Azithromycin
Azithromycin: 500 mg
|
Doxycycline
n=11 Participants
200 mg of Doxycycline
Doxycycline: 200 mg
|
Metronidazole
n=11 Participants
500 mg of Metronidazole
Metronidazole: 500 mg
|
Placebo
n=4 Participants
Inactive Ingredient
Placebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
|
|---|---|---|---|---|
|
Endometrial Growth
MacConkey Agar (gram neg selective)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Endometrial Growth
No Growth
|
4 Participants
|
7 Participants
|
8 Participants
|
1 Participants
|
|
Endometrial Growth
Trypic Soy Non-Selective Agar
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Endometrial Growth
Mannitol Salt Agar (Staph selective)
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Endometrial Growth
Streptococcus Agar (Strep selective)
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Metronidazole
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Azithromycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Doxycycline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metronidazole
n=41 participants at risk
Patients receivingMetronidazole for preprocedure antibiotic
|
Azithromycin
n=46 participants at risk
Patients receiving Azithromycin for preprocedure antibiotic
|
Doxycycline
n=42 participants at risk
Patients receiving Doxycycline for preprocedure antibiotic
|
Placebo
n=45 participants at risk
Patients receiving Placebo preprocedure
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Inpatient Hospitalization
|
2.4%
1/41 • Number of events 1 • One week
Patients involved in study were called on telephone at one week to assess for any adverse events.
|
0.00%
0/46 • One week
Patients involved in study were called on telephone at one week to assess for any adverse events.
|
0.00%
0/42 • One week
Patients involved in study were called on telephone at one week to assess for any adverse events.
|
0.00%
0/45 • One week
Patients involved in study were called on telephone at one week to assess for any adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator
MedStar Washington Hospital Center
Phone: 202-877-7479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place