The Proactive Support of Labor Study

Not Applicable

Completed

• Conditions: Obstetric Labor Complications
• Interventions: Behavioral: support of labor as usual; Behavioral: Proactive support of labor

• Registration Number: NCT03056313
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-14
• Study Start: 2017-02-15
• Study First Posted: 2017-02-17
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 347

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
support of labor as usual	support of labor as usual	delayed labor; 3-4 cm opening of the cervix and regular contractions
proactive support of labor	Proactive support of labor	delayed labor; 1 cm opening and painful contractions

Primary Outcome Measures

Name	Time	Method
maternal satisfaction with deliver	1 week	validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010)
number of pathological deliveries	2 days	number non-normal deliveries

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway