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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin | Active Comparator | Amoxicillin 500mg three times in a day for 1 week |
|
| Erythromycin | Placebo Comparator | Erythromycin 500mg four times in a day for 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug |
| ||
| Erythromycin |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| drug discontinuation rates | The drug discontinuation rates between the two groups will be compared | within 1 week of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of side effect. | Occurrence of side effects will be considered between the two groups. The side effects include nausea, diarrhoea,vomiting and loss of appetite | 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Temitope O Okunola, MB;BS | Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife | Ile-Ife | Imesi Ile | 220001 | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7968119 | Background | Alary M, Joly JR, Moutquin JM, Mondor M, Boucher M, Fortier A, Pinault JJ, Paris G, Carrier S, Chamberland H, et al. Randomised comparison of amoxycillin and erythromycin in treatment of genital chlamydial infection in pregnancy. Lancet. 1994 Nov 26;344(8935):1461-5. doi: 10.1016/s0140-6736(94)90288-7. |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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|
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |