Utrogestan officially approved in Romania for the prevention of preterm birth in women with a short cervix

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The medicine Utrogestan has received official approval from the Romanian National Agency for Medicines and Medical Devices (ANMDMR) for a new important therapeutic indication: the prevention of preterm birth in pregnant women with a short cervix (≤ 25 mm).

The new indication concerns vaginal administration of the product and is supported by international recommendations with level A evidence, according to the ISUOG Guidelines 2022 and SOGC Guidelines 2020. Moreover, this therapy was already acknowledged in Romania through the 2019 Obstetrics-Gynecology Guidelines and the Minister of Health’s Order issued in December 2020. The recent update of the Utrogestan leaflet now provides a firm legal basis for prescribing the drug in this clinical scenario.

Key aspects of Utrogestan use:

  • It can be administered vaginally in a daily dose exceeding 200 mg in a single application;
  • Administration is allowed up to and including the 34th week of pregnancy;
  • It is recommended for patients diagnosed with a short cervix (≤ 25 mm), a condition often associated with an increased risk of preterm birth.

According to clinical data presented by the Romanian Society of Obstetrics and Gynecology (SROG), the efficacy and safety of Utrogestan are supported by a substantial body of evidence: more than 18,000 patients in randomized clinical trials and over 10,000 documented cases in assisted reproduction settings.

“We consider this approval a significant step for obstetric practice and recommend the application of this therapeutic indication in the direct interest of the patient,” stated Prof. Elvira Brătila, President of SROG.