Subject: To understand
the real-life usage and prescription pattern for available
strengths of SUSTEN capsules in prevention of preterm birth.
Preterm birth has been defined as any birth before 37 completed
weeks of gestation. Though the incidence of preterm birth is on the
rise but events leading to this are not clear and well understood.
Etiology is thought to be multifactorial, whether these factors play
independently or work in unison is still not clear.
Recent
data suggest that progesterone is crucial for maintaining uterine
quiescence in the later weeks of pregnancy. Functional withdrawal of
progesterone activity at the uterine level is seen at the onset of
labour, both at term and preterm. This observation is the basis of
progesterone supplementation in prevention of preterm labour. A
number of recommendations have been made for oral, injectable and
vaginal progesterone supplementation for this purpose.
We have
planned this surveillance to assess the in-practice usage and
prescription pattern of ‘SUSTEN Capsule’ in prevention of preterm
birth in real-life scenario.
We invite
you to participate in this surveillance and share your experience of
__ patients with risk of preterm birth in your routine clinical
practice. Thus, this is not an experimental study because the
product will be prescribed and purchased as you and your patients
normally do.
If you
agree to participate, we request you to provide us a copy of
relevant information from the patient’s case papers, and
investigational reports if any (which we call source documents), in
the standard data collection forms (which we call DCF). You will be
responsible for seeking patient consent and for verifying the DCF
with the source documents to ensure that the DCF signed by you are
free from errors or omissions. The DCF will not contain the
patient’s names so as to ensure confidentiality.
We trust
you and we are partners in ensuring safe and effective drug therapy.
In that spirit we hope you will consent to participate in this
surveillance. If you do, please sign and return the enclosed reply
document along with your visiting card for accuracy of records.
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