The Proactive Support of Labor Study

Obstetric Labor Complications Clinical Trial

— PAF  

Official title:

The Proactive Support of Labor Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056313
• Other study ID #: 2014/1788
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of pathological deliveries	number non-normal deliveries	2 days
Primary	maternal satisfaction with deliver	validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010)	1 week