Vaginal Progesterone to Reduce the Risk of Another Preterm Birth

Exclusion criteria

• ✕. The female subject is between 18 and 45 years of age at the time of screening.
• ✕. The pregnancy has an estimated gestational age between 16 0/7 weeks and 22 6/7 weeks.
• ✕. The subject speaks either English or a common local language.
• ✕. The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.
• ✕. In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.
• ✕. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
• ✕. The subject has been treated with a progestogen within the previous 4 weeks.
• ✕. The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease).