Subject: To understand the usage and prescription pattern of SUSTEN SR Tablets in Threatened Miscarriage/Recurrent Pregnancy Loss patients in real-life clinical practice

Miscarriage is defined as the spontaneous loss of pregnancy before the fetus reaches viability. Miscarriage is a frequent outcome of pregnancy, with major emotional implications to the couple experiencing such an event. Threatened miscarriage is the commonest complication of early pregnancy and affects about 20% of pregnancies. It presents with vaginal bleeding with or without abdominal cramps. On the other hand recurrent miscarriages are post implantation failures in natural conception. Increasing age of women, smoking, obesity or polycystic ovary syndrome (PCOS) and a previous history of miscarriage are risk factors for threatened miscarriage.¹ Progesterone, which is a female sex hormone, is secreted by the corpus luteum in the ovary to prepare the endometrium and to provide an adequate immune environment for the establishment of pregnancy. Low progesterone levels have been associated with an increased risk of first trimester miscarriage. It has been postulated that progesterone supplementation in the early weeks of pregnancy may help to establish a sufficient immune response in early pregnancy and to prevent miscarriages.² Medications that mimic the action of progesterone are known as progestogens.

We have planned this surveillance to assess the in-practice usage and prescription pattern of ‘SUSTEN SR Tablets’ in Threatened miscarriage/ Recurrent Pregnancy Loss patients in real-life scenario.

We invite you to participate in this surveillance and share your patients experience with Threatened miscarriage/ Recurrent Pregnancy Loss 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.

Yours truly,

Ms. Rashmi Parekh
Sr. GM – Sales & Marketing
Sun Pharma Laboratories Ltd.
Sun House CTS No. 201 B/1,
Western Express Highway,
Goregaon (E), Mumbai - 400 063
Tel: + 91 22 4324 1234/4324