S. Japonicum and Pregnancy Outcomes

NCT00486863 | Completed Phase 2 Results

• 1 other identifier: 06-0039
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schistosomiasis

Keywords

Philippines, Schistosoma japonicum, Schistosomiasis, pregnant women, fetuses, 08-0049

Outcome Measures

Primary Outcomes (1)

• Mean Newborn Birth Weight

  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.

  Within 24 hours of delivery.

Secondary Outcomes (19)

• Number of Participants Whose Pregnancy Resulted in a Live Birth

  At delivery

• Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation

  14 weeks and 32 weeks gestation

• Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation

  14 weeks and 32 weeks gestation

• Median Maternal Hepcidin at 32 Weeks Gestation

  32 weeks gestation

• Mean Change in Maternal Weight From 14 to 32 Weeks Gestation

  14 and 32 weeks gestation

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo at 12-16 weeks gestation.

Other: Placebo

Praziquantel

EXPERIMENTAL

Praziquantel at 12-16 weeks gestation.

Drug: Praziquantel

Interventions

Praziquantel DRUG

60 mg/kg administered orally given in split dose (30/mg/kg each) separated by 3 hours; over-encapsulated in gelatin capsules. Two capsule sizes will be made which will be differentiated by color; these will contain 300 mg or 150 mg to allow for best dosing by weight.

Praziquantel

Placebo OTHER

Made with the same color coded gelatin capsules with the inert compound dextrose.

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Research Institute for Tropical Medicine - Health Compound

Muntinlupa City, National Capital Region, 1781, Philippines

Location

Related Publications (6)

• Salam RA, Das JK, Bhutta ZA. Effect of mass deworming with antihelminthics for soil-transmitted helminths during pregnancy. Cochrane Database Syst Rev. 2021 May 17;5(5):CD005547. doi: 10.1002/14651858.CD005547.pub4.

  PMID: 33998661 DERIVED

• Colt S, Jarilla B, Baltazar P, Tallo V, Acosta LP, Wu HW, Barry CV, Kurtis JD, Olveda RM, Friedman JF, Jiz MA. Effect of maternal praziquantel treatment for Schistosoma japonicum infection on the offspring susceptibility and immunologic response to infection at age six, a cohort study. PLoS Negl Trop Dis. 2021 Apr 16;15(4):e0009328. doi: 10.1371/journal.pntd.0009328. eCollection 2021 Apr.

  PMID: 33861768 DERIVED

• Abioye AI, McDonald EA, Park S, Joshi A, Kurtis JD, Wu H, Pond-Tor S, Sharma S, Ernerudh J, Baltazar P, Acosta LP, Olveda RM, Tallo V, Friedman JF. Maternal, placental and cord blood cytokines and the risk of adverse birth outcomes among pregnant women infected with Schistosoma japonicum in the Philippines. PLoS Negl Trop Dis. 2019 Jun 12;13(6):e0007371. doi: 10.1371/journal.pntd.0007371. eCollection 2019 Jun.

  PMID: 31188820 DERIVED

• Abioye AI, Park S, Ripp K, McDonald EA, Kurtis JD, Wu H, Pond-Tor S, Sharma S, Ernerudh J, Baltazar P, Acosta LP, Olveda RM, Tallo V, Friedman JF. Anemia of Inflammation during Human Pregnancy Does Not Affect Newborn Iron Endowment. J Nutr. 2018 Mar 1;148(3):427-436. doi: 10.1093/jn/nxx052.

  PMID: 29546300 DERIVED

• Blake RA, Park S, Baltazar P, Ayaso EB, Monterde DB, Acosta LP, Olveda RM, Tallo V, Friedman JF. LBW and SGA Impact Longitudinal Growth and Nutritional Status of Filipino Infants. PLoS One. 2016 Jul 21;11(7):e0159461. doi: 10.1371/journal.pone.0159461. eCollection 2016.

  PMID: 27441564 DERIVED

• Olveda RM, Acosta LP, Tallo V, Baltazar PI, Lesiguez JL, Estanislao GG, Ayaso EB, Monterde DB, Ida A, Watson N, McDonald EA, Wu HW, Kurtis JD, Friedman JF. Efficacy and safety of praziquantel for the treatment of human schistosomiasis during pregnancy: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2016 Feb;16(2):199-208. doi: 10.1016/S1473-3099(15)00345-X. Epub 2015 Nov 2.

  PMID: 26511959 DERIVED

MeSH Terms

Conditions

Schistosomiasis; Schistosomiasis japonica

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jennifer Friedman, M.D., Ph.D
• Organization: Warren Alpert Medical School of Brown University, Lifespan Center for International Health Research

jennifer_friedman@brown.edu

(401) 444-7449

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 15, 2007
• Study Start: August 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 26, 2016
• Results First Posted: February 7, 2014

Record last verified: 2014-07

Locations

PH (1)