Trial | NCT00710242  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    263
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.
Study Started
Apr 30
2007
Primary Completion
Mar 31
2009
Study Completion
May 31
2009
Last Update
May 19
2009
Estimate

Drug DF01

Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery)

Drug Placebo

Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery)

1 Experimental

DF01

2 Placebo Comparator

Criteria 

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
No Results Posted