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Completed

NCT Number: NCT01946256

Treatment of Antenatal Chlamydia Infection

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.

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Key information

Conditions

Chlamydia Trachomatis Infection in Pregnancy

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife

Ile-Ife, Imesi Ile, 220001, Nigeria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

Erythromycin

Drug

Primary outcomes

  1. completion of course of medication and microbiological clearance

    Time frame: 4 weeks after treatment

    The women will be screened 4 weeks after treatment to check for microbiological clearance

Secondary outcomes

  1. drug discontinuation rates

    Time frame: within 1 week of treatment

    The drug discontinuation rates between the two groups will be compared

Other outcomes

  1. occurrence of side effect.

    Time frame: 1 week

    Occurrence of side effects will be considered between the two groups. The side effects include nausea, diarrhoea,vomiting and loss of appetite

Sponsors and collaborators

Lead sponsor

Obafemi Awolowo University Teaching Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
Mar 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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