The Proactive Support of Labor Study (PAF)

Norwegian University of Science and Technology

Status: Completed

Conditions: Obstetric Labor Complications

Treatments: Behavioral: support of labor as usual; Behavioral: Proactive support of labor

Study type: Interventional

Funder types: Other

Identifiers

NCT03056313

2014/1788

Details and patient eligibility

About

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.

Enrollment: 347 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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347 participants in 2 patient groups

proactive support of labor

Experimental group

Description:

delayed labor; 1 cm opening and painful contractions

Treatment:

Behavioral: Proactive support of labor

support of labor as usual

Active Comparator group

Description:

delayed labor; 3-4 cm opening of the cervix and regular contractions

Treatment:

Behavioral: support of labor as usual