MedTrace Logo

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

NCT03944317 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-05-10

No results posted yet for this study

Summary

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.

Conditions

  • Malaria in Pregnancy
  • Pregnancy

Interventions

DRUG

Sulfadoxine pyrimethamine

SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.

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

Sponsors & Collaborators

  • Federal Medical Centre, Owo

    lead INDUSTRY

Principal Investigators

  • Dr Aiyeyemi Adeyinka Joseph, MB;BS, FWACS · Head of Department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-11-30
Completion
2020-01-31

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03944317 on ClinicalTrials.gov