Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa (IMPROVE)

IPTp With Dihydroartemisinin-piperaquine and Azithromycin for Malaria, Sexually Transmitted and Reproductive Tract Infections in Pregnancy in High Sulphadoxine-pyrimethamine Resistance Areas in Kenya, Malawi and Tanzania: an International Multi-centre 3-arm Placebo-controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202005615501026

Enrollment

4680

Registered

2020-05-08

Start date

2017-09-15

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Malaria Sexually Transmitted and Reproductive Tract Infections in Pregnancy

Interventions

dihydroartemisinin piperaquine and Azithromycin

dihydroartemisinin piperaquine and placebo azithromycin

sulfamethoxazole trimethoprim

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Pregnant women between 16-28 weeks' gestation Viable singleton pregnancy Resident of the study area Willing to adhere to scheduled and unscheduled study visit procedures Willing to deliver in a study clinic or hospital Provide written informed consent

Exclusion criteria

Exclusion criteria: Multiple pregnancies (i.e. twin/triplets) HIV-positive Known heart ailment Severe malformations or non-viable pregnancy if observed by ultrasound History of receiving IPTp-SP during this current pregnancy Unable to give consent Known allergy or contraindication to any of the study drugs

Design outcomes

Primary

Measure	Time frame
Adverse pregnancy outcome [ Time Frame: 8 months ] Composite of foetal loss (spontaneous abortion or stillbirth), or singleton live births born small-for-gestational age (SGA), or with low birthweight (LBW), or preterm (PT) (SGA-LBW-PT), or subsequent neonatal death by day 28.;Placental malaria detected by histology [ Time Frame: 6 months from randomisation ] Prevalence of placental malaria detected in full placental section by histology	—

Measure

Time frame

Adverse pregnancy outcome [ Time Frame: 8 months ] Composite of foetal loss (spontaneous abortion or stillbirth), or singleton live births born small-for-gestational age (SGA), or with low birthweight (LBW), or preterm (PT) (SGA-LBW-PT), or subsequent neonatal death by day 28.;Placental malaria detected by histology [ Time Frame: 6 months from randomisation ] Prevalence of placental malaria detected in full placental section by histology

—

Secondary

Measure	Time frame
Composite of foetal loss and neonatal mortality [ Time Frame: 8 months ] Composite of foetal loss (spontaneous abortion or stillbirth) and neonatal mortality;SGA-LBW-PT composite [ Time Frame: 6 months ] Composite of small for gestational age, low birth weight or preterm birth;SGA [ Time Frame: 6 months ] Small for gestational age using the new INTERGROWTH population reference's 10th percentile;LBW [ Time Frame: 6 months ] Low birth weight defined as a corrected birth weight below 2.5 kg;PT [ Time Frame: 6 months ] Preterm birth defined as birth at a gestational age above 28 weeks but less than 37 completed weeks;Neonatal length and stunting [ Time Frame: 8 months ] Neonatal length and stunting;Clinical malaria during pregnancy [ Time Frame: 6 months from randomisation ] Incidence of clinical malaria during pregnancy;Malaria infection during pregnancy detected by microscopy and PCR [ Time Frame: 6 months from randomisation ] Prevalence and incidence of peripheral maternal (blood) malaria infection during pregnancy by microscopy and PCR;Composite placental malaria detected by microscopy, by molecular methods or by histology [ Time Frame: 6 months from randomisation ] Prevalence of placental malaria by microscopy, PCR and placental histology;Placental malaria detected by microscopy [ Time Frame: 6 months from randomisation ] Prevalence of placental malaria detected in maternal placental blood by microscopy;Placental malaria detected by molecular methods (PCR) [ Time Frame: 6 months from randomisation ] Prevalence of placental malaria detected in maternal placental blood by PCR;Maternal nutritional status [ Time Frame: 6 months from randomisation ] Changes in maternal nutritional status by MUAC and BMI.;Maternal anaemia during pregnancy and delivery [ Time Frame: 6 months from randomisation ] Prevalence and incidence of maternal anaemia (Hb 480ms, 4 - 6 hours after on day 2 treatment administration. Only on the DP containing arms.;QTc-prolongation [ Time	—

Measure

Time frame

Composite of foetal loss and neonatal mortality [ Time Frame: 8 months ] Composite of foetal loss (spontaneous abortion or stillbirth) and neonatal mortality;SGA-LBW-PT composite [ Time Frame: 6 months ] Composite of small for gestational age, low birth weight or preterm birth;SGA [ Time Frame: 6 months ] Small for gestational age using the new INTERGROWTH population reference's 10th percentile;LBW [ Time Frame: 6 months ] Low birth weight defined as a corrected birth weight below 2.5 kg;PT [ Time Frame: 6 months ] Preterm birth defined as birth at a gestational age above 28 weeks but less than 37 completed weeks;Neonatal length and stunting [ Time Frame: 8 months ] Neonatal length and stunting;Clinical malaria during pregnancy [ Time Frame: 6 months from randomisation ] Incidence of clinical malaria during pregnancy;Malaria infection during pregnancy detected by microscopy and PCR [ Time Frame: 6 months from randomisation ] Prevalence and incidence of peripheral maternal (blood) malaria infection during pregnancy by microscopy and PCR;Composite placental malaria detected by microscopy, by molecular methods or by histology [ Time Frame: 6 months from randomisation ] Prevalence of placental malaria by microscopy, PCR and placental histology;Placental malaria detected by microscopy [ Time Frame: 6 months from randomisation ] Prevalence of placental malaria detected in maternal placental blood by microscopy;Placental malaria detected by molecular methods (PCR) [ Time Frame: 6 months from randomisation ] Prevalence of placental malaria detected in maternal placental blood by PCR;Maternal nutritional status [ Time Frame: 6 months from randomisation ] Changes in maternal nutritional status by MUAC and BMI.;Maternal anaemia during pregnancy and delivery [ Time Frame: 6 months from randomisation ] Prevalence and incidence of maternal anaemia (Hb 480ms, 4 - 6 hours after on day 2 treatment administration. Only on the DP containing arms.;QTc-prolongation [ Time

—

Countries

Kenya

Contacts

Public ContactHellen;Hellen Hellen Barsosio;Barsosio

Senior Research Officer;Senior Research Officer

hellen.barsosio@lstmed.ac.uk;hellen.barsosio@lstmed.ac.uk+254724464507;+254724464507

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026