Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)

May 8, 2019 updated by: AHMED Ganiyu Olanipekun, Federal Medical Centre, Owo

Randomized Controlled Trial of Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Prophylaxis Against Malaria in Pregnancy (IPT)

AZITHROMYCIN VERSUS SULPHADOXINE-PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL

OBJECTIVE: This study is to compare the efficacy of Azithromycin versus sulphadoxine-pyrimethamine as options of chemoprophylaxis against malaria in pregnancy.

METHOD: This is a randomized controlled trial with parallel assignment that will be conducted in the Obstetrics and Gynaecology department of the Federal Medical Centre. One hundred and sixty four (164) pregnant women who are eligible will be randomly allocated to 2 groups (A and B) of 84 each, using computer generated random numbers. Group A will receive sulfadoxine-pyrimethamine for malaria prophylaxis while Group B will receive azithromycin. All other aspects of antenatal care till delivery will be the same for all the women recruited. Maternal venous blood samples for malaria parasitaemia will be collected on recruitment and repeated at follow-up visits at any gestation there are symptoms of malaria; maternal peripheral blood film, placental and cord blood samples will be collected at delivery. All data will be documented in the data collection sheet. The results obtained will be subjected to statistical analysis using statistical package for social sciences (SPSS) version 21, Armonk, NY:IBM. The level of significance will be set at 5%. Outcomes will be compared across groups using Chi-square.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study design and Patient recruitment

The design is a randomized comparative controlled study. Candidates for the study will be recruited from the antenatal booking clinic of our institution after being duly informed that participation is voluntary. Informed consent will be obtained after the purpose, procedure, benefits, discomfort, risks and precautions associated with the study have been dully explained to them. Due diligence will be taken in adequately responding to any question or concern raised about the study. It will fully be explained to them that their participation is entirely voluntary. Also, if they are unwilling at any point to participate, they will be completely at liberty to discontinue their participation in the study which will not in any away affect their further and adequate management in the hospital. It will be explained that their participation in the study will not have any negative impact on them and their unborn babies and it has no financial benefits but the outcomes of the study may contribute to improved antenatal care. However, if there is additional financial cost (though not immediately foreseen) to any patient outside the cost of routine ANC visit, the investigator shall arrange for modest compensation. Consented eligible pregnant woman will be recruited and those enrolled will be alloted into the two groups A and B of SP and Azithromycin respectively using a computer program (SPSS software version 21, Armonk, NY:IBM) generated sequence of numbers. Sequentially numbered sealed envelope containing either SP or AZ labelled will be allotted one after the other to participants. The personnel involved in the data collection and laboratory staff analyzing the samples will all not be aware of which group of patient is taking SP or Azithromycin while the doctors involved in administering the medication and the patients will be aware of which is being administered.

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr Eniowo Roland, FMCOG,FWACS
  • Phone Number: 08033867026

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • booked pregnant women
  • Consent for the study
  • Availability for follow-up during the pregnancy by keeping the next ANC appointment
  • Willingness to deliver at the study site
  • Age ≥ 18years
  • comply with use of IPT-SP or Azithromycin medication as required by the study

Exclusion Criteria:

  • Women treated for malaria in the index pregnancy
  • Women who are severely ill (have medical conditions requiring hospital admission)
  • Women who report prior adverse drug reaction to sulpha-containing medications and Azithromycin
  • Patients with multiple gestations, sickle cell disease, HIV, IUGR and APH
  • Women who did not want to participate in the study
  • Age <18years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sulfadoxine pyrimethamine
SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.
Drug: Sulfadoxine pyrimethamine
SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.
Other Names:
  • fansidar
Active Comparator: Azithromycin
A total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks
Drug: Azithromycin
A total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks
Other Names:
  • Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
malaria parasitaemia during pregnancy
Time Frame: through study completion, an average of 6 months
number of pregnant women with maternal peripheral blood parasitaemia during pregnancy among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
malaria parasitaemia at the point of delivery
Time Frame: at the time of delivery
number of pregnant women with maternal peripheral blood and placental parasitaemia, number of new born with cord blood parasitaemia at birth among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy
at the time of delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
low birth weight
Time Frame: at the time of delivery
number of low birthweight babies among pregnant women who use sulfadoxine pyrimethamine and azithromycin for malaria prevention in pregnancy
at the time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Medical Centre, Owo

Investigators

  • Study Director: Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS, head of department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

January 31, 2020

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMCOWO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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