Ultrasound and Prolonged Labour

This study has been completed.
Sponsor:
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00915148
First received: June 3, 2009
Last updated: October 11, 2010
Last verified: October 2010
  Purpose

This observational study is designed to correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically, the study will evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.


Condition Intervention
Prolonged Labor
Other: Ultrasound examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: First Stage 3D-ultrasound During Prolonged Labour.

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Ceasarian section [ Time Frame: Intra-labour ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to delivery [ Time Frame: Intra-labour ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women with prolonged labour
Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.
Other: Ultrasound examination
Trans-abdominal and trans-perineal 3D ultrasound examination

Detailed Description:

AIM:

To correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.

Objective:

Labours have traditionally been evaluated by manuals methods of the "delivery helper" - midwives or doctor. There are many factors that will prolong labour such as malcontractions, disproportion of the birth canal and malpresentation/position. In about 20% of primigravidae, the first stage will last longer than 10 hours.

In this study we want to evaluate different ultrasounds measurements to see if ultrasound can be used to predict the outcome of labour.

Methods:

A descriptive observational study, with one ultrasound examination. The labour will be handled according to definitions by Woman's department, Stavanger University Hospital, and WHO.

The use of stimulating agents, as Oxytocin, will be evaluated after manual examinations, specific definitions and criteria.

The results of the ultrasound examinations will be evaluated after the delivery, since the results are not to be used clinically during the delivery.

Inclusion criteria will be primigravidae, with one fetus, after the 37th week. Feta head presentation. Ruptured membranes, at least one hour before inclusion. Prolonged first stage according to WHO definitions. The target is to include 100 subjects.

Inter- and intraobserver variation will be evaluated with intraclass coefficients. We will analyze operative delivery with normal vaginal delivery. Also, two groups divided by the stage 0 will be evaluated with statistics analyzes.

Time to delivery will be evaluated with Kaplan Meier and Cox regression analyzes.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primi gravidae, with one fetus, after the 37th week. Cephalic presentation. Prolonged first stage according to WHO definitions.

Criteria

Inclusion Criteria:

  • Primi gravidae
  • >37th week
  • Cephalic presentation
  • Prolonged first stage according to WHO definitions.

Exclusion Criteria:

  • Multiple pregnancies
  • Intrauterine fetal death
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915148

Locations
Norway
Stavanger University Hospital
Stavanger, Norway, NO-4011
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Erik Andreas Torkildsen, MD Helse Stavanger HF
Study Director: Torbjørn Moe Eggebø, MD, PhD Helse Stavanger HF
  More Information

Publications:
Responsible Party: Stein Tore Nilsen, Director of R&D, Stavanger University Hospital
ClinicalTrials.gov Identifier: NCT00915148     History of Changes
Other Study ID Numbers: StaHF500804
Study First Received: June 3, 2009
Last Updated: October 11, 2010
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Helse Stavanger HF:
Prolonged labor
Ultrasound
Caeserian section

ClinicalTrials.gov processed this record on August 20, 2014