Trial Outcomes & Findings for Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT (NCT NCT03862495)
NCT ID: NCT03862495
Last Updated: 2024-09-05
Results Overview
Number of women who get tested for CT and N. gonorrhoeae (NG) divided by the number of women being contacted about the study at the recruitment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
at the time of enrollment
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
Chlamydia Screening and Treatment
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
63
|
65
|
|
Overall Study
NOT COMPLETED
|
37
|
35
|
Reasons for withdrawal
| Measure |
Chlamydia Screening and Treatment
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
37
|
35
|
Baseline Characteristics
Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
Baseline characteristics by cohort
| Measure |
Chlamydia Screening and Treatment
n=63 Participants
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
n=65 Participants
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.72 years
STANDARD_DEVIATION 0.533 • n=5 Participants
|
29.18 years
STANDARD_DEVIATION 0.576 • n=7 Participants
|
29.45 years
STANDARD_DEVIATION 0.392 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Premature rupture of membranes
Yes
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Premature rupture of membranes
No
|
45 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Premature delivery
Yes
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Premature delivery
No
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Low birth weight
Yes
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Low birth weight
No
|
60 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Pregnancy loss
Yes
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Pregnancy loss
No
|
61 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the time of enrollmentNumber of women who get tested for CT and N. gonorrhoeae (NG) divided by the number of women being contacted about the study at the recruitment
Outcome measures
| Measure |
Chlamydia Screening and Treatment
n=100 Participants
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
n=100 Participants
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Response Rate at Recruitment
|
100 Participants
|
100 Participants
|
PRIMARY outcome
Timeframe: Within 1 week after the notification of positive test resultsPopulation: Out of the 100 participants screened for each arm, 12 in the Chlamydia group tested positive and 3 in the Control group tested positive.
Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results
Outcome measures
| Measure |
Chlamydia Screening and Treatment
n=12 Participants
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
n=3 Participants
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Compliance to Receive CT or NG Treatment
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 1 or 3 months after the treatmentPopulation: Out of the 100 participants screened for each arm, 3 in the Chlamydia group were treated and 1 in the Control group was treated.
Number of women who re-tested negative either at 1 or at 3 months after treatment divided by the number of women who received CT or NG treatment
Outcome measures
| Measure |
Chlamydia Screening and Treatment
n=3 Participants
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
n=1 Participants
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Number of Participants Considered as Cured After Treatment
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearNumber of any adverse pregnancy outcomes, including stillbirth (a baby who dies after 28 weeks of pregnancy, but before or during birth), fetal death, infant death, miscarriage (pregnancy loss between 12-28 weeks), preeclampsia (pre eclampsia: hypertension with proteinuria occurs after 20 weeks of pregnancy; eclampsia: convulsions that occur on the basis of preeclampsia and cannot be explained by other reasons), low birth weight (\<2500g), smaller than gestational age, preterm birth (\<37 gestational weeks), birth defect, and premature rupture of membrane (spontaneous rupture of fetal membranes before delivery, classified into full-term PROM and preterm PROM based on the gestational age) in both groups through study completion.
Outcome measures
| Measure |
Chlamydia Screening and Treatment
n=63 Participants
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
n=65 Participants
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Number of Participants With Adverse Pregnancy Outcomes
|
21 participants
|
22 participants
|
SECONDARY outcome
Timeframe: 1 month after the treatmentNumber of women who get tested for CT and NG 1 month after the treatment divided by the number of women who receive CT or NG treatment.
Outcome measures
| Measure |
Chlamydia Screening and Treatment
n=63 Participants
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
n=65 Participants
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Number of Participants Considered as Cured at 1 Month After the Treatment
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months after the treatmentNumber of women who get tested for CT and NG 3 months after the treatment divided by the number of women who re-tested CT or NG positive at 1 month after the treatment
Outcome measures
| Measure |
Chlamydia Screening and Treatment
n=63 Participants
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
n=65 Participants
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Number of Participants Considered Cured at 3 Months After the Treatment
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearNumber of women who are followed-up by the end of pregnancy or in the event of adverse pregnancy outcomes divided the number of women who are enrolled at the recruitment.
Outcome measures
| Measure |
Chlamydia Screening and Treatment
n=100 Participants
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Control
n=100 Participants
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
|---|---|---|
|
Number of People Who Completed Follow-up
|
63 Participants
|
65 Participants
|
Adverse Events
Maternal Chlamydia Screening and Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fetus or Infant of Mother Receiving Chlamydia Screening and Treatment
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Maternal Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fetus or Infant of Mother Receiving Control
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maternal Chlamydia Screening and Treatment
n=65 participants at risk
At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
|
Fetus or Infant of Mother Receiving Chlamydia Screening and Treatment
n=65 participants at risk
Fetuses in utero or infants of mothers assigned chlamydia screening and treatment
|
Maternal Control
n=63 participants at risk
This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
C. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
Azithromycin: Azithromycin 1g administered as a single oral dose
Partner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
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Fetus or Infant of Mother Receiving Control
n=63 participants at risk
Fetuses in utero or infants of mothers assigned control
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|---|---|---|---|---|
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Pregnancy, puerperium and perinatal conditions
Adverse pregnancy outcomes
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7.7%
5/65 • Number of events 5 • Through study completion, an average of 1 year.
Given the severity of the underlying illness, participants were expected to have adverse pregnancy outcomes. All adverse pregnancy outcomes were captured as Advere Events (AEs). In addition, all Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction was reported as an AE. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
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32.3%
21/65 • Number of events 26 • Through study completion, an average of 1 year.
Given the severity of the underlying illness, participants were expected to have adverse pregnancy outcomes. All adverse pregnancy outcomes were captured as Advere Events (AEs). In addition, all Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction was reported as an AE. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
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0.00%
0/63 • Through study completion, an average of 1 year.
Given the severity of the underlying illness, participants were expected to have adverse pregnancy outcomes. All adverse pregnancy outcomes were captured as Advere Events (AEs). In addition, all Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction was reported as an AE. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
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34.9%
22/63 • Number of events 30 • Through study completion, an average of 1 year.
Given the severity of the underlying illness, participants were expected to have adverse pregnancy outcomes. All adverse pregnancy outcomes were captured as Advere Events (AEs). In addition, all Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction was reported as an AE. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
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Additional Information
Deputy Chief Physician Li Changchang
Skin Disease Hospital of Southern Medical University
Phone: 18585239166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place