The Proactive Support of Labor Study (PAF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03056313|
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : April 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstetric Labor Complications||Behavioral: Proactive support of labor Behavioral: support of labor as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Proactive Support of Labor Study|
|Actual Study Start Date :||February 15, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: proactive support of labor
delayed labor; 1 cm opening and painful contractions
Behavioral: Proactive support of labor
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.
Active Comparator: support of labor as usual
delayed labor; 3-4 cm opening of the cervix and regular contractions
Behavioral: support of labor as usual
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.
- number of pathological deliveries [ Time Frame: 2 days ]number non-normal deliveries
- maternal satisfaction with deliver [ Time Frame: 1 week ]validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056313
|Contact: Raija HT Dahlø||0047 email@example.com|
|Contact: Eszter Vanky, md firstname.lastname@example.org|
|St Olavs Hospital||Recruiting|
|Contact: Møyfrid Brenne Fehn Moyfrid.Brenne.Fehn@stolav.no|
|Principal Investigator:||Eszter Vanky, md prof||Norwegian University of Science and Technology|