Trial · NCT00486863

S. Japonicum and Pregnancy Outcomes

NCT00486863, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2014-02-07

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ConductScience Library. S. Japonicum and Pregnancy Outcomes. Trials, record NCT00486863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00486863

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: S. Japonicum and Pregnancy Outcomes
NCT number: NCT00486863
Status: Completed
Phases: Phase 2
Enrollment: 370 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Schistosomiasis
Interventions: Praziquantel, Placebo
First posted: 2007-06-15
Last updated: 2016-01-26
Results first posted: 2014-02-07

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Newborn Birth Weight	Within 24 hours of delivery.	Birth weight was collected for live infants at the time of delivery by a trained midwife, or within 24 hours of delivery for participants who chose to deliver at home with a helot, a birth attendant without formal training.
Secondary	Number of Participants Whose Pregnancy Resulted in a Live Birth	At delivery	Each participant was followed until delivery to record if the outcome of the pregnancy was a live birth. Live births were defined as the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord had been cut or the placenta was attached.
Secondary	Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation	14 weeks and 32 weeks gestation	Hemoglobin concentration in a venous blood sample collected at 14 and 32 weeks gestation was measured using a multi-analyte analyzer. Each participant's change in hemoglobin concentration between the two timepoints was determined, and the mean and standard deviation for each group calculated.
Secondary	Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation	14 weeks and 32 weeks gestation	To assess total body iron, one needs to assess the storage compartment, which will contain sequestered iron, and the functional compartment, which represents bioavailable iron. Body iron status is defined by the two laboratory measurements that reflect these compartments, ferritin and serum transferrin receptor. The serum transferrin receptor:ferritin ratio has been shown in quantitative phlebotomy studies to provide an accurate assessment of total body iron over the entire range of status. At 14 and 32 weeks gestation, a blood sample was collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio. Each participant's change in ratio was calculated, and the median and interquartile range were determined for each group.
Secondary	Median Maternal Hepcidin at 32 Weeks Gestation	32 weeks gestation	Anemia of inflammation was assessed via maternal urine hepcidin levels. In response to inflammation, elevated serum levels of hepcidin is synthesized. Hepcidin causes sequestration of iron from bio-available forms to storage forms such as ferritin and decreases intestinal absorption of iron. Hepcidin was measured in participants' urine at 32 weeks gestation.
Secondary	Mean Change in Maternal Weight From 14 to 32 Weeks Gestation	14 and 32 weeks gestation	Maternal weight gain was assessed by measuring participants' weight in kilograms. The weight increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.
Secondary	Mean Change in Maternal Thigh Skinfold Thickness From 14 to 32 Weeks Gestation	14 and 32 weeks gestation	Maternal fat stores were measured by thigh skinfold thickness obtained using a Holtain skinfold caliper. The thickness increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.
Secondary	Newborn Median Serum Transferrin Receptor:Ferritin Ratio	0-6 days after delivery.	To assess total body iron, the serum transferrin receptor:ferritin ratio was assessed in the infant. At delivery, a heel stick blood sample and a cord blood sample were collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio.
Secondary	Number of Subjects With Reduction in S. Japonicum Egg Counts From Screening to 22 Weeks Gestation of Greater Than 90 Percent	Screening and 22 weeks gestation	Parasitologic response to treatment was evaluated by counting S. japonicum eggs per gram of stool at screening and again at 22 weeks gestation. Success of treatment was pre-specified as greater than 90 percent reduction in egg count from screening to 22 weeks gestation.
Secondary	Number of Participants Reporting Serious Adverse Events Within 24 Hours of Dosing	Within 24 hours of dosing	Participants were observed in hospital for 24 hours after dosing for serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof (for reasons other than the 24-hour observation period); resulted in a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of these outcomes.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Newborn Birth Weight	Within 24 hours of delivery.	All newborns for whom birth weights were reported were included in the analysis.	kilograms	MEAN
SECONDARY	Number of Participants Whose Pregnancy Resulted in a Live Birth	At delivery	All participants for whom the status of the infant at delivery was reported are included in the analysis.	participants	NUMBER
SECONDARY	Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation	14 weeks and 32 weeks gestation	All participants for whom hemoglobin concentrations were reported are included in the analysis.	grams/deciliter	MEAN
SECONDARY	Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation	14 weeks and 32 weeks gestation	All participants for whom transferrin receptor:ferritin ratio was reported at both timepoints are included in the analysis.	ratio	MEDIAN
SECONDARY	Median Maternal Hepcidin at 32 Weeks Gestation	32 weeks gestation	All participants for whom hepcidin levels were reported are included in the analysis.	nanograms/milliliter	MEDIAN
SECONDARY	Mean Change in Maternal Weight From 14 to 32 Weeks Gestation	14 and 32 weeks gestation	All participants for whom weight was reported at both timepoints were included in this analysis.	kilograms	MEAN
SECONDARY	Mean Change in Maternal Thigh Skinfold Thickness From 14 to 32 Weeks Gestation	14 and 32 weeks gestation	All participants for whom thigh skinfold thickness was reported at both timepoints were included in this analysis.	millimeters	MEAN
SECONDARY	Newborn Median Serum Transferrin Receptor:Ferritin Ratio	0-6 days after delivery.	All infants for whom transferrin receptor and ferritin were reported are included in the analysis.	ratio	MEDIAN
SECONDARY	Number of Subjects With Reduction in S. Japonicum Egg Counts From Screening to 22 Weeks Gestation of Greater Than 90 Percent	Screening and 22 weeks gestation	All participants for whom egg counts were reported are included in the analysis.	participants	NUMBER
SECONDARY	Number of Participants Reporting Serious Adverse Events Within 24 Hours of Dosing	Within 24 hours of dosing	All participants were included in this analysis.	participants	NUMBER

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Newborn Birth Weight	Placebo Control at 12-16 Weeks Gestation	2.85	Standard Deviation 0.39	kilograms
Mean Newborn Birth Weight	Praziquantel at 12-16 Weeks Gestation	2.85	Standard Deviation 0.44	kilograms
Number of Participants Whose Pregnancy Resulted in a Live Birth	Placebo Control at 12-16 Weeks Gestation	181		participants
Number of Participants Whose Pregnancy Resulted in a Live Birth	Praziquantel at 12-16 Weeks Gestation	181		participants
Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation	Placebo Control at 12-16 Weeks Gestation	-0.42	Standard Deviation 1.39	grams/deciliter
Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation	Praziquantel at 12-16 Weeks Gestation	-0.44	Standard Deviation 1.38	grams/deciliter
Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation	Placebo Control at 12-16 Weeks Gestation	0.0	Inter-Quartile Range 75.88	ratio
Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation	Praziquantel at 12-16 Weeks Gestation	0.0	Inter-Quartile Range 162.4	ratio
Median Maternal Hepcidin at 32 Weeks Gestation	Placebo Control at 12-16 Weeks Gestation	2.58	Inter-Quartile Range 5.06	nanograms/milliliter
Median Maternal Hepcidin at 32 Weeks Gestation	Praziquantel at 12-16 Weeks Gestation	3.38	Inter-Quartile Range 4.32	nanograms/milliliter

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Control at 12-16 Weeks Gestation	184
Overall Study	STARTED	Praziquantel at 12-16 Weeks Gestation	186
Overall Study	COMPLETED	Placebo Control at 12-16 Weeks Gestation	183
Overall Study	COMPLETED	Praziquantel at 12-16 Weeks Gestation	183
Overall Study	NOT COMPLETED	Placebo Control at 12-16 Weeks Gestation	1
Overall Study	NOT COMPLETED	Praziquantel at 12-16 Weeks Gestation	3

Source ClinicalTrials.gov

Adverse events130

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	Placebo Control at 12-16 Weeks Gestation	51	184	52
other	Anaemia	Blood and lymphatic system disorders	Praziquantel at 12-16 Weeks Gestation	47	186	48
other	Abdominal pain lower	Gastrointestinal disorders	Placebo Control at 12-16 Weeks Gestation	15	184	16
other	Abdominal pain lower	Gastrointestinal disorders	Praziquantel at 12-16 Weeks Gestation	12	186	12
other	Pyrexia	General disorders	Placebo Control at 12-16 Weeks Gestation	13	184	14
other	Pyrexia	General disorders	Praziquantel at 12-16 Weeks Gestation	16	186	17
other	Nasopharyngitis	Infections and infestations	Placebo Control at 12-16 Weeks Gestation	7	184	8
other	Nasopharyngitis	Infections and infestations	Praziquantel at 12-16 Weeks Gestation	15	186	16
other	Urinary tract infection	Infections and infestations	Placebo Control at 12-16 Weeks Gestation	13	184	13
other	Urinary tract infection	Infections and infestations	Praziquantel at 12-16 Weeks Gestation	10	186	11

1 to 10 of 130Source ClinicalTrials.gov

See all 130 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Control at 12-16 Weeks Gestation
Total, all-cause mortality	Praziquantel at 12-16 Weeks Gestation
Total, other adverse events	Placebo Control at 12-16 Weeks Gestation	159	184
Total, other adverse events	Praziquantel at 12-16 Weeks Gestation	176	186
Total, serious adverse events	Placebo Control at 12-16 Weeks Gestation	34	184
Total, serious adverse events	Praziquantel at 12-16 Weeks Gestation	45	186

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26511959	DERIVED	PubMed
27441564	DERIVED	PubMed
29546300	DERIVED	PubMed
31188820	DERIVED	PubMed
33861768	DERIVED	PubMed
33998661	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Praziquantel at 12-16 Weeks Gestation vs Placebo Control at 12-16 Weeks Gestation: Number of Subjects With Reduction in S. Japonicum Egg Counts From Screening to 22 Weeks Gestation of Greater Than 90 Percent	Trial comparisons
Praziquantel at 12-16 Weeks Gestation vs Placebo Control at 12-16 Weeks Gestation: Number of Participants Experiencing Fetal Loss by Abortion	Trial comparisons
Praziquantel at 12-16 Weeks Gestation vs Placebo Control at 12-16 Weeks Gestation: Number of Participants Whose Infant Was Born With Congenital Anomalies	Trial comparisons
Praziquantel at 12-16 Weeks Gestation vs Placebo Control at 12-16 Weeks Gestation: Number of Participants Whose Pregnancy Resulted in a Live Birth	Trial comparisons
Praziquantel at 12-16 Weeks Gestation vs Placebo Control at 12-16 Weeks Gestation: Number of Participants With Pre-eclampsia	Trial comparisons
Praziquantel at 12-16 Weeks Gestation vs Placebo Control at 12-16 Weeks Gestation: Number of Participants Reporting Serious Adverse Events Within 24 Hours of Dosing	Trial comparisons
Praziquantel at 12-16 Weeks Gestation vs Placebo Control at 12-16 Weeks Gestation: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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