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

Dilafor

Status and phase: Completed; Phase 2

Conditions: Labor; Pregnancy

Treatments: Drug: DF01; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00710242

PPL02

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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263 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

DF01

Treatment:

Drug: DF01

2

Placebo Comparator group

Treatment:

Drug: Placebo