Prediction of Preterm delivery by the Electrohysterogram
| ISRCTN | ISRCTN07603227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07603227 |
| Protocol serial number | 10620 |
| Sponsor | Maxima Medical Center (Netherlands) |
| Funder | Maxima Medical Center (Netherlands) |
- Submission date
- 05/12/2011
- Registration date
- 31/07/2012
- Last edited
- 24/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The electrohysterogram (EHG) is a new way of measuring contractions of the uterus. In this study the EHG will be used to monitor patients with premature contractions. The aim is to investigate whether the EHG can predict when delivery will occur.
Who can participate?
You can participate if you are admitted the hospital for imminent premature delivery between 24 and 34 weeks of gestation.
What does the study involve?
Besides the usual tests, you will have an additional test: the electrohysterogram (EHG). This means a measurement using a patch that is connected to the skin of your abdomen. The result will only be used for research and not for your treatment.
What are the possible benefits and risks of participating?
The measurement is not dangerous for you or your baby and has no side effects.
Where is the study run from?
The study will be run from the Maxima Medical Center in Veldhoven but four other hospitals in the Netherlands will participate as well.
When is the study starting and how long is it expected to run for?
The study started in March 2012 and will end in June 2014.
Who is funding the study?
This research is paid for by the Maxima Medical Center Veldhoven.
Who is the main contact?
Hinke de Lau
h.delau@mmc.nl
Contact information
Scientific
Tannhauserdreef 272
Utrecht
3561HR
Netherlands
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational multicenter cross-sectional cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Prediction of Preterm delivery by the Electrohysterogram: an observational cohort study |
| Study acronym | PoPE |
| Study objectives | The electrohysterogram is better predictor of preterm delivery than current diagnostics. On 30/01/2014 the overall trial end date was changed from 01/02/2013 to 01/06/2014. |
| Ethics approval(s) | Medical Ethical Committee, Maxima Medical Center Veldhoven, 06/12/2011 |
| Health condition(s) or problem(s) studied | Preterm delivery, threatening preterm labor |
| Intervention | Electrohysterogram: power spectral density peak frequency, conduction velocity Current diagnostics: digital examination, cervical length, fetal fibronectin All diagnostics will be performed at admission: a 4-channel electrohysterogram recording of 30 minutes using a fixed electrode configuration, a digital examination, transvaginal cervical length measurement and fetal fibronectin testing. Electrohysterogram information will be blinded to the attending physician, analysis will be done afterwards. The peak frequency of the power density spectrum (by Fourier Transform) will be identified. For conduction velocity the corresponding action potentials will be visually identified in the different channels. The velocity (vector) will be calculated from these intervals from which the speed (scalar) will be used as conduction velocity. Two cohorts will formed based on delivery within or after 7 days after measurement. |
| Intervention type | Other |
| Primary outcome measure(s) | Sensitivity, specificity, positive and negative predicting value for predicting preterm delivery within 7 days from measurement |
| Key secondary outcome measure(s) | Area Under the Curve of the Receiver Operating Characteristic (ROC) curve for predicting preterm delivery within 7 days from measurement |
| Completion date | 01/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Patients admitted for threatened preterm labor 2. Gestational age between 23+5 and 34+0 weeks 3. Clinically evaluated symptoms of preterm labor: at least 6 contractions in 60 minutes based on the (cardio) tocogram and/or maternal perception |
| Key exclusion criteria | Patients in active labor: cervical dilatation ≥3cm |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 01/06/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3561HR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/06/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
