Treatment of Antenatal Chlamydia Infection

Phase 2

Completed

• Conditions: Chlamydia Trachomatis Infection in Pregnancy
• Interventions: Drug: Amoxicillin; Drug: Erythromycin

• Registration Number: NCT01946256
• Lead Sponsor: Obafemi Awolowo University Teaching Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Study Start: 2013-10
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-26
• Last Update Posted: 2014-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amoxicillin	Amoxicillin	Amoxicillin 500mg three times in a day for 1 week
Erythromycin	Erythromycin	Erythromycin 500mg four times in a day for 1 week

Primary Outcome Measures

Name	Time	Method
completion of course of medication and microbiological clearance	4 weeks after treatment	The women will be screened 4 weeks after treatment to check for microbiological clearance

Secondary Outcome Measures

Name	Time	Method
drug discontinuation rates	within 1 week of treatment	The drug discontinuation rates between the two groups will be compared

Trial Locations

Locations (1)

Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife; 🇳🇬 Ile Ife, Imesi Ile, Nigeria