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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
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.


Condition or disease Intervention/treatment Phase
Obstetric Labor Complications Behavioral: Proactive support of labor Behavioral: support of labor as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. number of pathological deliveries [ Time Frame: 2 days ]
    number non-normal deliveries

  2. maternal satisfaction with deliver [ Time Frame: 1 week ]
    validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056313


Contacts
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Contact: Raija HT Dahlø 0047 73412258 raija.h.dahlo@ntnu.no
Contact: Eszter Vanky, md prof eszter.vanky@ntnu.no

Locations
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Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Møyfrid Brenne Fehn       Moyfrid.Brenne.Fehn@stolav.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Principal Investigator: Eszter Vanky, md prof Norwegian University of Science and Technology
Publications:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03056313    
Other Study ID Numbers: 2014/1788
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Delivery, Obstetric
Uterine Contraction
Cervix Uteri
Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications