Study to Assess Safety and Efficacy of DF01 in Reducing Prolonged Labor

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Assess the Safety and Efficacy or Pre-Treatment With DF01 During Late Pregnancy in Reducing Prolonged Labor

The study is a Proof-of-concept study to evaluate if DF01 can prevent protracted labor. Time to delivery will be measured from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes.

Inclusion Criteria:

• healthy nulliparous females
• normal singleton pregnancy
• intact membranes

Exclusion Criteria:

• breech or other abnormal presentation
• intercurrent illness
• pregnancy complications
• vaginal bleeding in third trimester
• etc