The Proactive Support of Labor Study

NCT03056313 | Completed

• 1 other identifier: 2014/1788
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Labor Complications

Keywords

Delivery, Obstetric; Uterine Contraction; Cervix Uteri

Outcome Measures

Primary Outcomes (2)

• number of pathological deliveries

  number non-normal deliveries

  2 days

• maternal satisfaction with deliver

  validated Childbirth Experience Questionnaire (CEQ) (Anna Dencker 2010)

  1 week

Study Arms (2)

proactive support of labor

EXPERIMENTAL

delayed labor; 1 cm opening and painful contractions

Behavioral: Proactive support of labor

support of labor as usual

ACTIVE COMPARATOR

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

Behavioral: support of labor as usual

Interventions

Proactive support of labor 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.

proactive support of labor

support of labor as usual 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.

support of labor as usual

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• spontaneous start of labor
• nulliparous
• term pregnancy
• cephalic presentation

You may not qualify if:

• twins
• breech presentation
• given birth earlier
• known uterine anomaly
• insulin treated diabetes
• preeclampsia
• other serious medical conditions in mother or fetus

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 32326956 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Eszter Vanky, md prof

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 17, 2017
• Study Start: February 15, 2017
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

NO (1)