Subject: To understand the real-life usage pattern for available strengths of SUSTEN SR Tablets 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 SR Tablets” 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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