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April 12, 2016American Journal of Obstetrics and GynecologyOpen Access

In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study

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Why the study?

Does oral valacyclovir 8 g daily improve the proportion of asymptomatic neonates in pregnant women carrying a symptomatic cytomegalovirus-infected fetus?

Population

43 pregnant women carrying a symptomatic cytomegalovirus-infected fetus. Excluded: fetuses with severe brain…

Comparison

Oral valacyclovir, 8 g daily, from prenatal… vs Historical cohort obtained by a meta-analysis of…

Design

Cohort, open-label

Follow-up

12 months

Authors

MLMarianne Leruez‐VilleDélégation Paris 5IGIdir GhoutCegedim (France)LBL. BussièresHôpital Necker-Enfants Malades

Discussion

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Implication

High-dosage valacyclovir may improve outcomes in moderately symptomatic fetal CMV; supports randomized confirmation before routine adoption.

Structured PICO

Does oral valacyclovir 8 g daily improve the proportion of asymptomatic neonates in pregnant women carrying a symptomatic cytomegalovirus-infected fetus?

P
Population
43 pregnant women carrying a symptomatic cytomegalovirus-infected fetus (defined by the presence of measurable extracerebral or mild cerebral ultrasound symptoms). Excluded: fetuses with severe brain anomalies on ultrasound and cases completely asymptomatic at presentation.
I
Intervention
Oral valacyclovir, 8 g daily, from prenatal diagnosis (median 25.9 weeks' gestation) until delivery or termination of pregnancy (median 89 days).
C
Comparator
Historical cohort obtained by a meta-analysis of the literature (no treatment).
O
Outcome
Proportion of asymptomatic neonates born to treated mothers.hard clinical

High-dosage valacyclovir given in pregnancy is effective for improving the outcome of moderately symptomatic cytomegalovirus-infected fetuses, significantly increasing the proportion of asymptomatic neonates.

Limitations

  • Not a randomized controlled trial

Cite This Study

Leruez‐Ville et al. (2016) studied this question.

synapsesocial.com/papers/6a717459e5469ee92be1fbechttps://doi.org/10.1016/j.ajog.2016.04.003
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Also Consider

Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A series of 238 cytomegalovirus primary infections during pregnancy: description and outcome2013 · 262 citations
  2. 2Does normal fetal brain ultrasound predict normal neurodevelopmental outcome in congenital cytomegalovirus infection?2011 · 75 citations
  3. 3Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design2010 · 531 citations
  4. 4Pregnancy outcomes following systemic prenatal acyclovir exposure: Conclusions from the international acyclovir pregnancy registry, 1984–19992004 · 197 citations