The Proactive Support of Labor Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 347
- Locations
- 1
- Primary Endpoint
- maternal satisfaction with deliver
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •spontaneous start of labor
- •nulliparous
- •term pregnancy
- •cephalic presentation
Exclusion Criteria
- •breech presentation
- •given birth earlier
- •known uterine anomaly
- •insulin treated diabetes
- •preeclampsia
- •other serious medical conditions in mother or fetus
Arms & Interventions
proactive support of labor
delayed labor; 1 cm opening and painful contractions
Intervention: Proactive support of labor (Behavioral)
support of labor as usual
delayed labor; 3-4 cm opening of the cervix and regular contractions
Intervention: support of labor as usual (Behavioral)
Outcomes
Primary Outcomes
maternal satisfaction with deliver
Time Frame: 1 week
validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010)
number of pathological deliveries
Time Frame: 2 days
number non-normal deliveries
Secondary Outcomes
No secondary outcomes reported