Chlamydia Trachomatis Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTC. 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.
DRUGAzithromycin
Azithromycin 1g administered as a single oral dose
OTHERPartner notification and treatment
Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
Sponsors
Southern Medical University, China
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Pilot Randomized Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. pregnant women on their first visit to the hospital (regardless of gestational age); 2. aged 18 or above; 3. agree to participate and sign an informed consent.
Exclusion criteria
1. systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit; 2. comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension); 3. diagnosed adverse pregnancy outcomes at recruitment (e.g., stillbirth); Women with a previous history of CT or NG and women with a prior adverse outcome will not be excluded. Instead, the investigators will conduct sub-analysis and check whether the intervention has different effects on different groups of pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate at Recruitment | at the time of enrollment | 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 |
| Compliance to Receive CT or NG Treatment | Within 1 week after the notification of positive test results | Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results |
| Number of Participants Considered as Cured After Treatment | 1 or 3 months after the 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 |
| Number of Participants With Adverse Pregnancy Outcomes | through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Considered Cured at 3 Months After the Treatment | 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 |
| Number of People Who Completed Follow-up | through study completion, an average of 1 year | 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. |
| Number of Participants Considered as Cured at 1 Month After the Treatment | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 63 |
| 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 | 65 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 37 | 35 |
Baseline characteristics
| Characteristic | Chlamydia Screening and Treatment | Total | Control |
|---|---|---|---|
| Age, Continuous | 29.72 years STANDARD_DEVIATION 0.533 | 29.45 years STANDARD_DEVIATION 0.392 | 29.18 years STANDARD_DEVIATION 0.576 |
| Low birth weight No | 60 Participants | 123 Participants | 63 Participants |
| Low birth weight Yes | 3 Participants | 5 Participants | 2 Participants |
| Pregnancy loss No | 61 Participants | 118 Participants | 57 Participants |
| Pregnancy loss Yes | 2 Participants | 10 Participants | 8 Participants |
| Premature delivery No | 60 Participants | 120 Participants | 60 Participants |
| Premature delivery Yes | 3 Participants | 8 Participants | 5 Participants |
| Premature rupture of membranes No | 45 Participants | 95 Participants | 50 Participants |
| Premature rupture of membranes Yes | 18 Participants | 33 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 63 Participants | 128 Participants | 65 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 63 Participants | 128 Participants | 65 Participants |
| Sex: Female, Male Female | 63 Participants | 128 Participants | 65 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 5 / 65 | 21 / 65 | 0 / 63 | 22 / 63 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 | 0 / 63 | 0 / 63 |
Outcome results
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
Time frame: Within 1 week after the notification of positive test results
Population: Out of the 100 participants screened for each arm, 12 in the Chlamydia group tested positive and 3 in the Control group tested positive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlamydia Screening and Treatment | Compliance to Receive CT or NG Treatment | 3 Participants |
| Control | Compliance to Receive CT or NG Treatment | 1 Participants |
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
Time frame: 1 or 3 months after the treatment
Population: Out of the 100 participants screened for each arm, 3 in the Chlamydia group were treated and 1 in the Control group was treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlamydia Screening and Treatment | Number of Participants Considered as Cured After Treatment | 0 Participants |
| Control | Number of Participants Considered as Cured After Treatment | 1 Participants |
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.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chlamydia Screening and Treatment | Number of Participants With Adverse Pregnancy Outcomes | 21 participants |
| Control | Number of Participants With Adverse Pregnancy Outcomes | 22 participants |
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
Time frame: at the time of enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlamydia Screening and Treatment | Response Rate at Recruitment | 100 Participants |
| Control | Response Rate at Recruitment | 100 Participants |
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.
Time frame: 1 month after the treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlamydia Screening and Treatment | Number of Participants Considered as Cured at 1 Month After the Treatment | 1 Participants |
| Control | Number of Participants Considered as Cured at 1 Month After the Treatment | 1 Participants |
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
Time frame: 3 months after the treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlamydia Screening and Treatment | Number of Participants Considered Cured at 3 Months After the Treatment | 1 Participants |
| Control | Number of Participants Considered Cured at 3 Months After the Treatment | 1 Participants |
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.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlamydia Screening and Treatment | Number of People Who Completed Follow-up | 63 Participants |
| Control | Number of People Who Completed Follow-up | 65 Participants |