MATERNAL-FETAL
MEDICINE
The Society for Maternal-Fetal (SMFM) released the following statement
in response to the published results of "Progestin's Role in Optimizing
Neonatal Gestation," more commonly referred to as the PROLONG trial, which
was recently published in the American Journal of Perinatology.
The PROLONG trial assessed the effectiveness of weekly injections of
17-alpha-hydroxyprogesterone caproate (17-OHPC) in reducing the incidence of
recurrent preterm birth and neonatal morbidity. Between 2009 and 2018, this
study enrolled more than 1,700 pregnant patients from nine countries and
ultimately concluded that 17-OHPC does not decrease recurrent preterm birth or
neonatal morbidity.
A previous large randomized control trial (Meis, 2003) also examined the
effectiveness of 17-OHPC. Unlike PROLONG, this study found a 34% reduction in
the incidence of recurrent preterm birth and significant reductions in several
neonatal complications.
In comparing the conflicting results of the PROLONG and Meis trials, one
important consideration is the different populations studied. The Meis trial
included a larger proportion of patients with additional risk factors for
preterm birth. For example, 20% of the patients in the Meis trial reported
smoking, compared to 8% in the PROLONG Trial. Other meaningful differences in
the populations included:
- Race/Ethnicity
- Number
of previous preterm births
- Marital status
- Reported
substance use
·
SMFM has reviewed the results of the PROLONG trial and has
released the SMFM Statement: Use of 17-alpha hydroxyprogesterone caproate for
prevention of recurrent preterm birth, which recommends that obstetric care
providers use an individualized approach as they council patients regarding the
use of 17-OHPC. It is reasonable for providers to continue to use 17-OHPC in
the context of a shared decision-making model that includes consideration of
risk level for recurrent PTB. Important factors to discuss include: uncertainly
regarding the benefit, the lack of short-term safety concerns, the possibility
of injection site pain, extra patient visits, and substantial costs.
·
Further, SMFM recommends additional research on 17-OHPC to
identify populations in whom it is likely to be effective.
·
SMFM's complete, updated clinical guidance will be published in
the American
Journal of Obstetrics and Gynecology, can be found on the SMFM
website, and will be addressed on Tuesday, October 29, 2019 at meeting of the
Food and Drug Administration's Bone, Reproductive and Urologic Drugs Advisory Committee.
Source: News Medical Life Sciences
For more information about the Gynecology Congress 2020 at San Francisco,USA during April 27-29, 2020
Email: gynecologycongress@frontierscongress.com
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