Phase 2
N=370
S. Japonicum and Pregnancy Outcomes
Schistosomiasis
Bottom Line
View on ClinicalTrials.gov: NCT00486863 ↗Enrolled (actual)
370
Serious AEs
21.3%
Results posted
Feb 2014
Primary outcome: Primary: Mean Newborn Birth Weight — 2.85; 2.85 kilograms — p=0.988
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Praziquantel (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Newborn Birth Weight |
2.85; 2.85 | 0.988 |
| SECONDARY Number of Participants Whose Pregnancy Resulted in a Live Birth |
181; 181 | >0.999 |
| SECONDARY Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation |
-0.42; -0.44 | 0.926 |
| SECONDARY Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation |
0.0; 0.0 | 0.502 |
| SECONDARY Median Maternal Hepcidin at 32 Weeks Gestation |
2.58; 3.38 | 0.439 |
| SECONDARY Mean Change in Maternal Weight From 14 to 32 Weeks Gestation |
0.33; 0.32 | 0.704 |
| SECONDARY Mean Change in Maternal Thigh Skinfold Thickness From 14 to 32 Weeks Gestation |
0.08; 0.08 | 0.517 |
| SECONDARY Newborn Median Serum Transferrin Receptor:Ferritin Ratio |
1.76; 1.33; 0.00; 0.00 | 0.524 |
| SECONDARY Number of Subjects With Reduction in S. Japonicum Egg Counts From Screening to 22 Weeks Gestation of Greater Than 90 Percent |
92; 157 | <0.001 sig |
| SECONDARY Number of Participants Reporting Serious Adverse Events Within 24 Hours of Dosing |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Fetal Loss by Abortion |
0; 0 | — |
| SECONDARY Number of Participants Reporting Abnormalities in Hematology Assessments Within 24 Hours of Dosing |
69; 60; 3; 0; 54; 56 | — |
| SECONDARY Number of Participants Reporting Abnormalities in Clinical Chemistry Assessments Within 24 Hours of Dosing |
127; 137; 23; 39; 8; 9 | — |
| SECONDARY Number of Participants Whose Infant Was Born With Congenital Anomalies |
1; 1 | 0.991 |
| SECONDARY Number of Participants With Pre-eclampsia |
0; 0 | — |
| SECONDARY Maternal Serum Cytokine Levels of TNF-alpha, TNF-alpha Receptors I and II, IL-1, and IL-6 |
— | — |
| SECONDARY Placental Blood Cytokine Levels |
— | — |
| SECONDARY Cytokeratin 18 Neo-epitope Staining as a Measure of Apoptosis |
— | — |
| SECONDARY Praziquantel Pharmacokinetic Concentrations |
814.7; 945.2; 687.8; 422.2 | — |
| SECONDARY 4-hydroxy Praziquantel Pharmacokinetic Concentrations |
4020.1; 4590.8; 5373.7; 4304.1 | — |
Summary
The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the mother and developing baby when the mother has schistosomiasis (a type of worm) infection, and whether the drug may improve the mother's and baby's health. The usual practice is to wait until after a mother has finished breast feeding before giving the medicine. Approximately 375 infected pregnant women, ages 18 and over, in endemic villages in Leyte, The Philippines will participate. Study volunteers 12-16 weeks pregnant will be given PZQ or an inactive pill (placebo) and stay in the hospital overnight. Small blood samples will be collected before and after the medication is taken. Three stool and urine samples will be taken during a total of 7 study visits. An ultrasound image (picture or outline of the unborn baby) will be performed. When the baby is born, a small blood sample will be taken. Mother and baby will be followed for up to 8 months before the baby is born and 1 month after.
Eligibility Criteria
Inclusion Criteria
For screening:
- Female, age 18 or over.
- Present to a study midwife with suspected pregnancy.
- Live in a study village.
For the main study:
- Infected with S. japonicum.
- Pregnancy as determined by urine pregnancy test.
- Age 18 or older.
- Participant is otherwise healthy as determined by history, physical exam, ultrasound and laboratory assessment.
- Pregnancy between 12-16 weeks gestation.
- Ability to provide informed consent to participate.
Exclusion Criteria
- Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound and laboratory assessment. In particular:
- History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g. active hepatitis, tuberculosis, heart disease.
- Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), Creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Grade 2 or higher abnormality of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will warrant exclusion. For hemoglobin, women with severe anemia defined as hemoglobin less than 7.0 g/dl will be excluded.
- Women with myoma on ultrasound that are sub-mucosal or women with myoma that is in any location and greater than 5 cm in size.
- Women with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of prematurity such as duplicate uterus, uterine septum.
- For less clear cases, the researchers will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. In the case of acute medical conditions such as urinary tract infection, pneumonia, febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness) or the illness self resolves if this occurs before 16 weeks gestation.
- Presence of cysts in the eye suggestive of neurocysticercosis.
- Regular use of a medication for a chronic medical condition.
- History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration.
- Fetus has congenital anomaly determined by 12-16 week ultrasound or is determined to be nonviable (e.g. blighted ovum).
- Twin or higher order pregnancy.
- Woman has been enrolled into this study for a previous pregnancy.
- Inability to comprehend study procedures and provide informed consent due to limited cognitive abilities or other, or refuses to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT00486863). 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.