Trial · NCT01443130
Chloroquine for Malaria in Pregnancy
NCT01443130, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2015-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chloroquine for Malaria in Pregnancy. Trials, record NCT01443130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01443130
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chloroquine for Malaria in Pregnancy
- NCT number
- NCT01443130
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 900 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Malaria
- Interventions
- Chloroquine, Sulfadoxine-pyrimethamine
- First posted
- 2011-09-29
- Last updated
- 2016-12-28
- Results first posted
- 2015-10-29
- Limitations and caveats
The observed placental malaria rate was lower than expected causing the study to be under powered. After review of a futility analysis, the Sponsor and DSMB recommended allowing the study to conclude as planned and not to increase the sample size.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Placental Malaria Infection Based on Histology | At delivery: Approximately 12-36 weeks after enrollment | The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue. |
| Secondary | Incidence of Placental Malaria by Placental Impression Smear | At delivery: Approximately 12-36 weeks after enrollment | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results. |
| Secondary | Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter) | From enrollment until delivery, approximately 12-36 weeks | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL). |
| Secondary | Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl) | From enrollment until delivery, approximately 12-36 weeks | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl. |
| Secondary | Incidence of Stillbirth | At delivery: Approximately 12-36 weeks after enrollment | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation. |
| Secondary | Incidence of Miscarriage | At delivery: Approximately 12-36 weeks after enrollment | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation. |
| Secondary | Incidence of Preterm Delivery | At delivery: Approximately 12-36 weeks after enrollment | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage. |
| Secondary | Infant Mortality Rate to 14 Weeks of Age | For 14 weeks after delivery. | Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery. |
| Secondary | Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams) | At delivery: Approximately 12-36 weeks after enrollment | Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams. |
| Secondary | Incidence of Intrauterine Growth Restriction (IUGR) | At delivery: Approximately 12-36 weeks after enrollment | Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Placental Malaria Infection Based on Histology | At delivery: Approximately 12-36 weeks after enrollment | All participants from whom the placental histopathology slides collected at the time of delivery were reviewed are included in the analysis. | percentage of pregnancies | NUMBER |
| SECONDARY | Incidence of Placental Malaria by Placental Impression Smear | At delivery: Approximately 12-36 weeks after enrollment | The analysis population includes all maternal participants whose pregnancies were followed to delivery and from whom a placenta was collected and an impression smear performed. | percentage of placentas | NUMBER |
| SECONDARY | Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter) | From enrollment until delivery, approximately 12-36 weeks | The analysis population includes all maternal participants. | percentage of maternal participants | NUMBER |
| SECONDARY | Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl) | From enrollment until delivery, approximately 12-36 weeks | The analysis population includes all maternal participants. | percentage of maternal participants | NUMBER |
| SECONDARY | Incidence of Stillbirth | At delivery: Approximately 12-36 weeks after enrollment | The analysis population includes all participants whose pregnancies were followed to delivery. | percentage of deliveries | NUMBER |
| SECONDARY | Incidence of Miscarriage | At delivery: Approximately 12-36 weeks after enrollment | The analysis population includes all maternal participants. | percentage of pregnancies | NUMBER |
| SECONDARY | Incidence of Preterm Delivery | At delivery: Approximately 12-36 weeks after enrollment | The analysis population includes all participants whose pregnancies were followed to delivery. | percentage of deliveries | NUMBER |
| SECONDARY | Infant Mortality Rate to 14 Weeks of Age | For 14 weeks after delivery. | The analysis population includes all enrolled infants. | percentage of infants | NUMBER |
| SECONDARY | Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams) | At delivery: Approximately 12-36 weeks after enrollment | The analysis population includes all infants born alive with weight data collected at birth. | percentage of infants | NUMBER |
| SECONDARY | Incidence of Intrauterine Growth Restriction (IUGR) | At delivery: Approximately 12-36 weeks after enrollment | This analysis population includes all infants with weight captured at delivery and with mothers having reported gestational age at delivery. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Placental Malaria Infection Based on Histology | Maternal Chloroquine Prophylaxis | 11.58 | 97.5% Confidence Interval 7.52 to 16.80 | percentage of pregnancies | |
| Incidence of Placental Malaria Infection Based on Histology | Maternal Chloroquine IPT | 15.42 | 97.5% Confidence Interval 10.67 to 21.21 | percentage of pregnancies | |
| Incidence of Placental Malaria Infection Based on Histology | Maternal SP IPT | 15.42 | 97.5% Confidence Interval 10.67 to 21.21 | percentage of pregnancies | |
| Incidence of Placental Malaria by Placental Impression Smear | Maternal Chloroquine Prophylaxis | 0 | 97.5% Confidence Interval 0.00 to 1.68 | percentage of placentas | |
| Incidence of Placental Malaria by Placental Impression Smear | Maternal Chloroquine IPT | 0 | 97.5% Confidence Interval 0.00 to 1.71 | percentage of placentas | |
| Incidence of Placental Malaria by Placental Impression Smear | Maternal SP IPT | 0.40 | 97.5% Confidence Interval 0.00 to 2.50 | percentage of placentas | |
| Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter) | Maternal Chloroquine Prophylaxis | 18.3 | 97.5% Confidence Interval 13.58 to 23.89 | percentage of maternal participants | |
| Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter) | Maternal Chloroquine IPT | 23.7 | 97.5% Confidence Interval 18.36 to 29.64 | percentage of maternal participants | |
| Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter) | Maternal SP IPT | 22.0 | 97.5% Confidence Interval 16.85 to 27.86 | percentage of maternal participants | |
| Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl) | Maternal Chloroquine Prophylaxis | 0.0 | 97.5% Confidence Interval 0.00 to 1.45 | percentage of maternal participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Maternal Chloroquine Prophylaxis | 300 | |
| Overall Study | STARTED | Maternal Chloroquine IPT | 300 | |
| Overall Study | STARTED | Maternal SP IPT | 300 | |
| Overall Study | STARTED | Infant Chloroquine Prophylaxis | 270 | |
| Overall Study | STARTED | Infant Chloroquine IPT | 274 | |
| Overall Study | STARTED | Infant SP IPT | 259 | |
| Overall Study | COMPLETED | Maternal Chloroquine Prophylaxis | 232 | |
| Overall Study | COMPLETED | Maternal Chloroquine IPT | 231 | |
| Overall Study | COMPLETED | Maternal SP IPT | 223 | |
| Overall Study | COMPLETED | Infant Chloroquine Prophylaxis | 231 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events612
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Maternal Chloroquine Prophylaxis | 12 | 300 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Maternal Chloroquine IPT | 20 | 300 | 21 |
| other | Anaemia | Blood and lymphatic system disorders | Maternal SP IPT | 17 | 300 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Infant Chloroquine Prophylaxis | 0 | 270 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Infant Chloroquine IPT | 0 | 274 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Infant SP IPT | 0 | 259 | 0 |
| other | Palpitations | Cardiac disorders | Maternal Chloroquine Prophylaxis | 16 | 300 | 16 |
| other | Palpitations | Cardiac disorders | Maternal Chloroquine IPT | 19 | 300 | 21 |
| other | Palpitations | Cardiac disorders | Maternal SP IPT | 8 | 300 | 8 |
| other | Palpitations | Cardiac disorders | Infant Chloroquine Prophylaxis | 0 | 270 | 0 |
1 to 10 of 612Source ClinicalTrials.gov
See all 612 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maternal Chloroquine Prophylaxis | ||
| Total, all-cause mortality | Maternal Chloroquine IPT | ||
| Total, all-cause mortality | Maternal SP IPT | ||
| Total, all-cause mortality | Infant Chloroquine Prophylaxis | ||
| Total, all-cause mortality | Infant Chloroquine IPT | ||
| Total, all-cause mortality | Infant SP IPT | ||
| Total, other adverse events | Maternal Chloroquine Prophylaxis | 255 | 300 |
| Total, other adverse events | Maternal Chloroquine IPT | 251 | 300 |
| Total, other adverse events | Maternal SP IPT | 234 | 300 |
| Total, other adverse events | Infant Chloroquine Prophylaxis | 195 | 270 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AI104702 | Antigen exposure in utero: impacts on newborn immunity and infectious diseases | CAIRO, CRISTIANA | UNIVERSITY OF MARYLAND BALTIMORE | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2013 to 2016 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01443130
GET https://conductscience.org/api/trials/v1/NCT01443130/results?page=2