Phase 3 N=1,703 Randomized Prevention

Chloroquine for Malaria in Pregnancy

Malaria

Bottom Line

View on ClinicalTrials.gov: NCT01443130 ↗

Enrolled (actual)

1,703

Serious AEs

13.6%

Results posted

Oct 2015

Primary outcome: Primary: Incidence of Placental Malaria Infection Based on Histology — 11.58; 15.42; 15.42 percentage of pregnancies — p=0.2441

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Chloroquine (Drug); Sulfadoxine-pyrimethamine (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Placental Malaria Infection Based on Histology	11.58; 15.42; 15.42	0.2441
SECONDARY Incidence of Placental Malaria by Placental Impression Smear	0; 0; 0.40	0.4941
SECONDARY Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)	18.3; 23.7; 22.0	0.3089
SECONDARY Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)	0.0; 0.3; 0.3	1.00
SECONDARY Incidence of Stillbirth	1.10; 0.37; 1.90	0.4979
SECONDARY Incidence of Miscarriage	0.33; 0.67; 1.00	0.6237
SECONDARY Incidence of Preterm Delivery	8.46; 9.89; 6.84	0.5187
SECONDARY Infant Mortality Rate to 14 Weeks of Age	2.22; 3.65; 3.09	0.5959
SECONDARY Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)	15.59; 10.98; 12.11	0.2566
SECONDARY Incidence of Intrauterine Growth Restriction (IUGR)	16.54; 18.01; 20.80	0.2553
SECONDARY Incidence of Active Placental Malaria Infection	3.09; 3.16; 4.74	0.3690
SECONDARY Incidence of Malaria Infection, All Species.	0.67; 1.67; 3.00	0.0630
SECONDARY Incidence of Clinical Malaria, All Species	0.67; 1.33; 3.00	0.0268 sig
SECONDARY Incidence of Infection in the Fetal Circulation	1.95; 2.78; 0.80	0.4501

Summary

The purpose of this study is to test prevention strategies for pregnancy-related malaria. Researchers will compare different malaria treatments and treatment schedules which include chloroquine therapy (weekly doses versus being dosed twice during pregnancy for 3 days each time) to the standard practice of preventive treatment intervals in pregnancy (with the drug sulfadoxine-pyrimethamine given twice during pregnancy). Participants will include 900 pregnant women, who will be assigned to one of three treatment groups. Blood samples will be collected at every visit before birth and any time the participant is ill to determine if malaria is present. Pregnant women will be monitored during pregnancy and newborns will be assessed at birth and followed until about 14 weeks. Participant involvement in the study is expected to last about 12 months.

Eligibility Criteria

Inclusion Criteria

Women who present to the Ndirande Antenatal Clinic (ANC) and meet the following inclusion criteria will be enrolled in the study: -Before the end of 27th week of gestation -First or second pregnancy -Anticipate remaining in Blantyre until 14 weeks after delivery -Agree to deliver at the Ndirande Health Centre or Queen Elizabeth Central Hospital (QECH) -Provision of informed consent

Exclusion Criteria

-Chronic use (>14 days) of any medication with antimalarial or antifolate activity -Human immunodeficiency virus (HIV) infection -Known high-risk pregnancy requiring regular supervision of an obstetrician -Allergy to any of the study drugs

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01443130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.