Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT (RCT)
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| ClinicalTrials.gov Identifier: NCT03862495 |
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Recruitment Status :
Recruiting
First Posted : March 5, 2019
Last Update Posted : March 2, 2022
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Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Southern Medical University, China
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chlamydia Trachomatis Infection | Diagnostic Test: C. trachomatis and N. gonorrhoeae Drug: Azithromycin Other: Partner notification and treatment | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Pilot Randomized Controlled Trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study |
| Actual Study Start Date : | May 21, 2020 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Diagnostic Test: 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.
Other Name: Roche Cobas Z480 Drug: Azithromycin Azithromycin 1g administered as a single oral dose
Other Name: Zithromax, Zmax Other: 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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Experimental: 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.
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Diagnostic Test: 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.
Other Name: Roche Cobas Z480 Drug: Azithromycin Azithromycin 1g administered as a single oral dose
Other Name: Zithromax, Zmax Other: Partner notification and treatment Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses |
Primary Outcome Measures :
- Response rate at recruitment [ Time Frame: 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 [ Time Frame: 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
- Rate of cure after treatment [ Time Frame: 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
- Incidence of adverse pregnancy outcomes [ Time Frame: through study completion, an average of 1 year ]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
Secondary Outcome Measures :
- Test for cure rate at 1 month after the treatment [ Time Frame: 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.
- Test for cure rate at 3 months after the treatment [ Time Frame: 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
- Follow-up rate [ Time Frame: 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862495
Contacts
| Contact: Juan Nie, MPH | 13802994274 ext 13802994274 | niejuan@seshglobal.org |
Locations
| China, Guangdong | |
| Dermatology Hospital of Southern Medical Hospital | Not yet recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Juan Nie 13802994274 ext 13802994274 niejuan@seshglobal.org | |
| Nanhai Hospital of Southern Medical University | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Tao Liu +86-18927588462 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Southern Medical University, China
Investigators
| Principal Investigator: | Weiming Tang, MD, PhD | University of North Carolina, Chapel Hill |
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT03862495 |
| Other Study ID Numbers: |
18-1168 |
| First Posted: | March 5, 2019 Key Record Dates |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | From December 2020 to May 2023 |
| Access Criteria: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
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Chlamydia Infections Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Communicable Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents |