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

Dilafor AB263 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

263

Conditions

Pregnancy Labor

Interventions

DF01DRUG

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)

PlaceboDRUG

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)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (18)

Kvinnokliniken Alvsborgs sjukhus Boras

Borås, Sweden

Gavle sjukhus

Gävle, Sweden

Sahlgrenska/Ostra sjukhuset

Gothenburg, Sweden

Outcomes

Primary Outcomes

Time from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes until partus in women with vaginal delivery

Time frame: See above

Secondary Outcomes

Complications of labor

Time frame: At delivery

Data from ClinicalTrials.gov

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