The Proactive Support of Labor Study

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: proactive support of labor
    • delayed labor; 1 cm opening and painful contractions
  • Active Comparator: support of labor as usual
    • delayed labor; 3-4 cm opening of the cervix and regular contractions

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Norwegian University of Science and Technology
  • Collaborator
    • St. Olavs Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eszter Vanky, md prof, Principal Investigator, Norwegian University of Science and Technology
  • Overall Contact(s)
    • Raija HT Dahlø, 0047 73412258, raija.h.dahlo@ntnu.no

References

Brenne Fehn M, Dahlø 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.

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