The Proactive Support of Labor Study

Study Overview
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Brief Summary
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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.

Official Title
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The Proactive Support of Labor Study

Conditions
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Obstetric Labor Complications

Intervention / Treatment
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* Behavioral: Proactive support of labor
* Behavioral: support of labor as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: proactive support of labor<br>delayed labor; 1 cm opening and painful contractions | Behavioral: Proactive support of labor<br>* 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.<br>|
| Active Comparator: support of labor as usual<br>delayed labor; 3-4 cm opening of the cervix and regular contractions | Behavioral: support of labor as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of pathological deliveries | number non-normal deliveries | 2 days | 
| maternal satisfaction with deliver | validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010) | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delivery, Obstetric, Uterine Contraction, Cervix Uteri