The Proactive Support of Labor Study

NCT ID: NCT03056313

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2021-05-31

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.

Detailed Description

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Conditions

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Obstetric Labor Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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proactive support of labor

delayed labor; 1 cm opening and painful contractions

Group Type EXPERIMENTAL

Proactive support of labor

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

support of labor as usual

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eszter Vanky, md prof

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Brenne Fehn M, Dahlo 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.

Reference Type BACKGROUND
PMID: 32326956 (View on PubMed)

Other Identifiers

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2014/1788

Identifier Type: -

Identifier Source: org_study_id

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