S. Japonicum and Pregnancy Outcomes

Brief Title

S. Japonicum and Pregnancy Outcomes

Official Title

S. Japonicum and Pregnancy Outcomes: A Randomized, Double Blind, Placebo Controlled Trial (RCT)

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.
    

Detailed Description

      This double-blind, placebo-controlled study will investigate praziquantel (PZQ) for the
      treatment of Schistosomiasis japonicum in pregnant women living in endemic villages of Leyte,
      The Philippines. The study will enroll 375 pregnant women, ages 18 and over, infected with S.
      japonicum. The primary study objective is to quantify the efficacy of PZQ treatment for S.
      japonicum at 12-16 weeks gestation on newborn birth weight among live births. This will be
      assessed by measuring birth weight within 96 hours of delivery to 10 grams. The secondary
      objectives are to: 1) assess treatment efficacy with respect to maternal and newborn
      nutritional status and maternal parasitologic response to treatment; 2) collect preliminary
      safety and toxicity data on use of PZQ among pregnant women and their newborns; 3) identify
      extra-placental mechanisms mediating the hypothesized beneficial effect of PZQ on birth
      outcomes; and 4) identify extra-placental mechanisms mediating the hypothesized beneficial
      effect of PZQ on birth outcomes. Participants will be involved in study related procedures
      for 9 months (8 months pre-natally and 1 month post-natally) for mother and infant. This
      study is linked to DMID protocol 08-0049.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Mean Newborn Birth Weight

Secondary Outcome

 Number of Participants Whose Pregnancy Resulted in a Live Birth

Condition

Schistosomiasis

Intervention

Praziquantel

Study Arms / Comparison Groups

 Control

Description:  Placebo at 12-16 weeks gestation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

370

Start Date

August 2007

Completion Date

November 2012

Primary Completion Date

November 2012

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:

               1. History of seizures or other neurologic disorder, chronic medical problem
                  determined by history or physical examination, e.g. active hepatitis,
                  tuberculosis, heart disease.

               2. 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.

               3. 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.

               4. 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.

               5. 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.
      

Gender

Female

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

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Location Countries

Philippines

Location Countries

Philippines

NCT ID

NCT00486863

Organization ID

06-0039

Responsible Party

Sponsor

Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study Sponsor

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Verification Date

July 2014