Status:
COMPLETED
Prevention of Congenital Toxoplasmosis With Pyrimethamine + Sulfadiazine Versus Spiramycine During Pregnancy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Congenital Toxoplasmosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Background : When a mother contracts toxoplasmosis during pregnancy, the parasite may be transmitted from to her unborn child. This results in congenital toxoplasmosis, which may cause damage to the e...
Detailed Description
The protocol is a comparison of 2 strategies to prevent mother-to-child transmission of T. gondii following maternal seroconversion. Screening for toxoplasmosis is mandatory in France. Patients with ...
Eligibility Criteria
Inclusion
- \> 18 years old
- Toxoplasmosis infection acquired during the pregnancy documented by at least one negative serology in the first trimester and seroconversion with presence of specific IgG antibodies
- Gestational age \> 14 weeks from last menstrual period
- Signature of informed consent
Exclusion
- Lack of a documented negative serology during the pregnancy
- Antiparasitic therapy with spiramycin, pyrimethamine or sulfa drugs for more than 10 days after seroconversion and before randomization,
- Known allergy to any of the study drugs, serious allergic conditions or G6PD deficiency,
- Known hepatic or renal insufficiency,
- Other ongoing severe conditions in mother or fetus
- Lack of public health insurance
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT01189448
Start Date
November 1 2010
End Date
April 1 2016
Last Update
September 29 2016
Active Locations (1)
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1
Hôpital Louis Mourier
Colombes, Hauts-de-Saine, France, 92700