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| Name | Class |
|---|---|
| Southern Medical University, China | OTHER |
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This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C. trachomatis in pregnant women can reduce adverse pregnancy outcomes.
Approximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group.
Women recruited for the study will be randomized to the intervention or control groups. Women in the intervention group will be tested in real time for C. trachomatis and Neisseria gonorrhoeae. Patients who test positive for either infection will be linked to physicians at the Center for treatment. For the control group, women will be tested immediately after childbirth or in the event of an adverse pregnancy outcome. In the event of a positive test result, a confirmation test will be run and if positive, the patient will be referred for treatment. The endpoint of the study is defined as either the occurrence of an adverse pregnancy outcome or delivery of a newborn.
Qualitative in-depth interviews will also be conducted with 20 of the women to explore their opinions, attitudes and feedback on the study process. University of North Carolina at Chapel Hill (UNC) investigators will work with the Nanhai Hospital of Southern Medical University and staff at Dermatology Hospital of Southern Medical University to oversee the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlamydia Screening and Treatment | Experimental | 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. |
|
| Control | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C. trachomatis and N. gonorrhoeae | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate at Recruitment | 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 | at the time of enrollment |
| Compliance to Receive CT or NG Treatment | Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results | Within 1 week after the notification of positive test results |
| Number of Participants Considered as Cured After Treatment | 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 | 1 or 3 months after the treatment |
| Number of Participants With Adverse Pregnancy Outcomes | Number 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Considered as Cured at 1 Month After the Treatment | Number 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. | 1 month after the treatment |
| Number of Participants Considered Cured at 3 Months After the Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiming Tang, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital of Southern Medical Hospital | Guangzhou | Guangdong | China | |||
| Nanhai Hospital of Southern Medical University |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
From December 2020 to May 2023
Investigator who proposes to use the data should have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Response Rate at Recruitment | 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 | Posted | Count of Participants | Participants | at the time of enrollment |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maternal 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse pregnancy outcomes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Adverse pregnancy outcomes that were also listed as the main study outcomes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deputy Chief Physician Li Changchang | Skin Disease Hospital of Southern Medical University | 18585239166 | lichch8@mail2.sysu.edu.cn |
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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 | Feb 12, 2018 | Jul 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D016358 | Contact Tracing |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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Pilot Randomized Controlled Trial
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|
|
| Azithromycin | Drug | Azithromycin 1g administered as a single oral dose |
|
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| Partner notification and treatment | Other | Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses |
|
Number 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 |
| 3 months after the treatment |
| Number of People Who Completed Follow-up | Number 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. | through study completion, an average of 1 year |
| Guangzhou |
| Guangdong |
| China |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Premature rupture of membranes | Count of Participants | Participants |
|
| Premature delivery | Count of Participants | Participants |
|
| Low birth weight | Count of Participants | Participants |
|
| Pregnancy loss | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| Primary | Compliance to Receive CT or NG Treatment | Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results | Out of the 100 participants screened for each arm, 12 in the Chlamydia group tested positive and 3 in the Control group tested positive. | Posted | Count of Participants | Participants | Within 1 week after the notification of positive test results |
|
|
|
| Primary | Number of Participants Considered as Cured After Treatment | 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 | Out of the 100 participants screened for each arm, 3 in the Chlamydia group were treated and 1 in the Control group was treated. | Posted | Count of Participants | Participants | 1 or 3 months after the treatment |
|
|
|
| Primary | Number of Participants With Adverse Pregnancy Outcomes | Number 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. | Posted | Number | participants | through study completion, an average of 1 year |
|
|
|
| Secondary | Number of Participants Considered as Cured at 1 Month After the Treatment | Number 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. | Posted | Count of Participants | Participants | 1 month after the treatment |
|
|
|
| Secondary | Number of Participants Considered Cured at 3 Months After the Treatment | Number 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 | Posted | Count of Participants | Participants | 3 months after the treatment |
|
|
|
| Secondary | Number of People Who Completed Follow-up | Number 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. | Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 5 |
| 65 |
| EG001 | Fetus or Infant of Mother Receiving Chlamydia Screening and Treatment | Fetuses in utero or infants of mothers assigned chlamydia screening and treatment | 0 | 65 | 0 | 65 | 21 | 65 |
| EG002 | Maternal 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 | 0 | 63 | 0 | 63 | 0 | 63 |
| EG003 | Fetus or Infant of Mother Receiving Control | Fetuses in utero or infants of mothers assigned control | 0 | 63 | 0 | 63 | 22 | 63 |
|
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| Organic Chemicals |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |