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Ultrasound Prediction of Prolonged Labour

H

Helse Stavanger HF

Status

Completed

Conditions

Prolonged Labor

Treatments

Other: Ultrasound examination

Study type

Observational

Funder types

Other

Identifiers

NCT00915148
StaHF500804

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Multiple pregnancies
  • Intrauterine fetal death

Trial design

110 participants in 1 patient group

Ultrasound examination
Description:
Women with prolonged Labour; Primi gravidae, single pregnancy, \>37 weeks, fetus alive, cephalic presentation.
Treatment:
Other: Ultrasound examination

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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