Treatment of Antenatal Chlamydia Infection

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01946256

Enrollment

220

Registered

2013-09-19

Start date

2013-10-31

Completion date

2014-03-31

Last updated

2014-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia Trachomatis Infection in Pregnancy

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

Interventions

DRUGErythromycin

DRUGAmoxicillin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
drug discontinuation rates	within 1 week of treatment	The drug discontinuation rates between the two groups will be compared

Other

Measure	Time frame	Description
occurrence of side effect.	1 week	Occurrence of side effects will be considered between the two groups. The side effects include nausea, diarrhoea,vomiting and loss of appetite

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026