Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study

Conditions
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Chlamydia Trachomatis Infection

Intervention / Treatment
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* Diagnostic Test: C. trachomatis and N. gonorrhoeae
* Drug: Azithromycin
* Other: Partner notification and treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women on their first visit to the hospital (regardless of gestational age); aged 18 or above; agree to participate and sign an informed consent. Exclusion Criteria: systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit; comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension); 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlamydia Screening and Treatment<br>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. | Diagnostic Test: C. trachomatis and N. gonorrhoeae<br>* 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.<br>* Other names: Roche Cobas Z480;Drug: Azithromycin<br>* Azithromycin 1g administered as a single oral dose<br>* Other names: Zithromax, Zmax;Other: Partner notification and treatment<br>* Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses<br>|
| Experimental: Control<br>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. | Diagnostic Test: C. trachomatis and N. gonorrhoeae<br>* 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.<br>* Other names: Roche Cobas Z480;Drug: Azithromycin<br>* Azithromycin 1g administered as a single oral dose<br>* Other names: Zithromax, Zmax;Other: Partner notification and treatment<br>* Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Rate of cure 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 | 
| Incidence of adverse pregnancy outcomes | Frequency of any adverse pregnancy outcomes, including stillbirth, fetal death, infant death, miscarriage, preeclampsia, smaller than gestational age, preterm birth, birth defect, and premature rupture of membrane in both groups through study completion | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test for cure rate 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 | 
| Test for cure rate 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 | 3 months after the treatment | 
| Follow-up rate | 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 |