Treatment of Antenatal Chlamydia Infection

Study Overview
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Brief Summary
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PREGNANT WOMEN IN ANTENATAL CLINIC WILL BE SCREENED FOR CHLAMYDIA TRACHOMATIS INFECTION WITH ENDOCERVICAL SWAB.THOSE THAT TEST POSITIVE AND SATISFY THE INCLUSION CRITERIA WILL BE COUNSELLED AND ENROLLED INTO THE STUDY AFTER OBTAINING INFORMED CONSENT.THE PARTICIPANTS WILL BE RANDOMISED INTO ONE OF THE TWO GROUPS.THE DRUGS WILL BE TAKEN FOR I WEEK AND THE SEXUAL PARTNER(S) WILL ALSO BE TREATED WITH DOXYCYCLINE FOR 1 WEEK. BARRIER CONTRACEPTION WILL ALSO BE USED DURING THE TREATMENT.THE SEXUAL PARTNERS WILL BE CONTACTED THROUGH TELEPHONE CALLS AND THE BENEFITS OF PARTICIPATING IN THE STUDY WILL BE EXPLAINED TO THEM. LATEX MALE CONDOM WILL BE GIVEN TO THE WOMEN. ALSO, FOLLOW-UP TELEPHONE CALLS WILL BE PUT ACROSS TO THEM DURING THE TREATMENT WEEK TO ENHANCE COMPLIANCE. A REPEAT ENDOCERVICAL SWAB WILL BE TAKEN 4 WEEKS AFTER TREATMENT TO CHECK FOR MICROBIOLOGICAL CLEARANCE. A STUDY PROFORMA WILL BE FILLED DURING THIS VISIT. THE DATA WILL BE ANALYSED USING STATISTICAL PACKAGE FOR SOCIAL SCIENCES VERSION 17.

Detailed Description
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AIM(S) OF THE RESEARCH TO ASSESS THE EFFICACY AND TOLERABILITY OF AMOXICILLIN COMPARED TO ERYTHROMYCIN IN TREATMENT OF ANTENATAL CHLAMYDIA INFECTION OBJECTIVES OF THE RESEARCH TO DETERMINE THE PREVALENCE OF CHLAMYDIA TRACHOMATIS INFECTION IN PREGNANCY TO COMPARE THE PROPORTION OF SUBJECTS WITH CLEARANCE OF ANTENATAL CHLAMYDIA TRACHOMATIS INFECTION BETWEEN THE ERYTHROMYCIN AND AMOXICILLIN GROUPS TO COMPARE THE OCCURENCE OF SIDE EFFECTS BETWEEN THE TWO GROUPS TO COMPARE THE DRUG DISCONTINUATION RATES BETWEEN THE TWO GROUP

Official Title
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Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial

Conditions
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Chlamydia Trachomatis Infection in Pregnancy

Intervention / Treatment
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* Drug: Amoxicillin
* Drug: Erythromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Test positive to Chlamydia rapid screening kit Estimated gestational age less than 36 weeks Consent to participate in the study Willingness or ability to comply with follow-up schedule Exclusion Criteria: Antenatal patients whose gestational age is more than 36 weeks History of reaction to any of the drugs Women with low lying placenta or placenta Praevia History of other antibiotics intake within two weeks of recruitment
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amoxicillin<br>Amoxicillin 500mg three times in a day for 1 week | Drug: Amoxicillin<br> <br> |
| Placebo Comparator: Erythromycin<br>Erythromycin 500mg four times in a day for 1 week | Drug: Erythromycin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion of course of medication and microbiological clearance | The women will be screened 4 weeks after treatment to check for microbiological clearance | 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug discontinuation rates | The drug discontinuation rates between the two groups will be compared | within 1 week of treatment |