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OpenTrials
Completed

NCT Number: NCT03056313

The Proactive Support of Labor Study

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.

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Key information

Conditions

Obstetric Labor Complications Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proactive support of labor

Behavioral

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.

support of labor as usual

Behavioral

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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Acronym: PAF

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2017
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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