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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 April 2022
Main ID:  NCT03056313
Date of registration: 13/02/2017
Prospective Registration: Yes
Primary sponsor: Norwegian University of Science and Technology
Public title: The Proactive Support of Labor Study PAF
Scientific title: The Proactive Support of Labor Study
Date of first enrolment: February 15, 2017
Target sample size: 347
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03056313
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Norway
Contacts
Name:     Eszter Vanky, md prof
Address: 
Telephone:
Email:
Affiliation:  Norwegian University of Science and Technology
Key inclusion & exclusion criteria

Inclusion Criteria:

- spontaneous start of labor

- nulliparous

- term pregnancy

- cephalic presentation

Exclusion Criteria:

- twins

- breech presentation

- given birth earlier

- known uterine anomaly

- insulin treated diabetes

- preeclampsia

- other serious medical conditions in mother or fetus



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Obstetric Labor Complications
Intervention(s)
Behavioral: Proactive support of labor
Behavioral: support of labor as usual
Primary Outcome(s)
number of pathological deliveries [Time Frame: 2 days]
maternal satisfaction with deliver [Time Frame: 1 week]
Secondary Outcome(s)
Secondary ID(s)
2014/1788
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
St. Olavs Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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