The Proactive Support of Labor Study (PAF)
Primary Purpose
Obstetric Labor Complications
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Proactive support of labor
support of labor as usual
Sponsored by
About this trial
This is an interventional supportive care trial for Obstetric Labor Complications focused on measuring Delivery, Obstetric, Uterine Contraction, Cervix Uteri
Eligibility 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
Sites / Locations
- St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
proactive support of labor
support of labor as usual
Arm Description
delayed labor; 1 cm opening and painful contractions
delayed labor; 3-4 cm opening of the cervix and regular contractions
Outcomes
Primary Outcome Measures
number of pathological deliveries
number non-normal deliveries
maternal satisfaction with deliver
validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010)
Secondary Outcome Measures
Full Information
NCT ID
NCT03056313
First Posted
February 13, 2017
Last Updated
April 6, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03056313
Brief Title
The Proactive Support of Labor Study
Acronym
PAF
Official Title
The Proactive Support of Labor Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The duration of labor is decisive for maternal and fetal health. Poor progression often results in tired mothers, bad experience, delivery complications and a demand for cesarean section in next pregnancy. Proactive support of labor is a method originally from the Netherlands.
The main idea is to define start of active labor earlier than the traditional "3-4 cm opening of the cervix and regular contractions" to be cervix < 0.5 cm in length, and 1 cm opening and painful contractions. From this point, it is expected to be a progress of 1cm/hour opening of cervix. If not, progress is supported by amniotomy or stimulation of contractions.
This method is embraced by several clinics with great enthusiasm. However, there are no randomized controlled trials to prove that this method is better than others.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor Complications
Keywords
Delivery, Obstetric, Uterine Contraction, Cervix Uteri
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
proactive support of labor
Arm Type
Experimental
Arm Description
delayed labor; 1 cm opening and painful contractions
Arm Title
support of labor as usual
Arm Type
Active Comparator
Arm Description
delayed labor; 3-4 cm opening of the cervix and regular contractions
Intervention Type
Behavioral
Intervention Name(s)
Proactive support of labor
Intervention Description
In case of delayed labor, active labor is defined at an earlier stage; labor support is given with 1 cm opening of the cervix and painful contractions. Labor support interventions are started then.
Intervention Type
Behavioral
Intervention Name(s)
support of labor as usual
Intervention Description
In case of delayed labor, active labor start is defined as usual at 3-4 cm opening of the cervix and regular contractions. Labor support interventions are started then.
Primary Outcome Measure Information:
Title
number of pathological deliveries
Description
number non-normal deliveries
Time Frame
2 days
Title
maternal satisfaction with deliver
Description
validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010)
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eszter Vanky, md prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
32326956
Citation
Brenne Fehn M, Dahlo R, Nielsen R, Laache I, Vanky E. Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial. Trials. 2020 Apr 23;21(1):358. doi: 10.1186/s13063-020-4191-9.
Results Reference
background
Learn more about this trial
The Proactive Support of Labor Study
We'll reach out to this number within 24 hrs