Chlamydia Trachomatis Infection in Pregnancy Clinical Trial
Official title:
Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial
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.
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: 1. Test positive to Chlamydia rapid screening kit 2. Estimated gestational age less than 36 weeks 3. Consent to participate in the study 4. Willingness or ability to comply with follow-up schedule Exclusion Criteria: 1. Antenatal patients whose gestational age is more than 36 weeks 2. History of reaction to any of the drugs 3. Women with low lying placenta or placenta Praevia 4. History of other antibiotics intake within two weeks of recruitment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Nigeria | Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife | Ile Ife | Imesi Ile |
| Lead Sponsor | Collaborator |
|---|---|
| Obafemi Awolowo University Teaching Hospital |
Nigeria,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | Yes |
| Primary | 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 | No |
| Secondary | drug discontinuation rates | The drug discontinuation rates between the two groups will be compared | within 1 week of treatment | No |