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van CCT (UK)

van CCT (UK)

Electrohysterography compared to external tocodynamometer and intra-uterine pressure catheter for uterine contraction monitoring during term labor.

- candidate number24473
- NTR NumberNTR5894
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jun-2016
- Secondary IDsNL48951.015.14 METC nummer: 1412
- Public TitleElectrohysterography compared to external tocodynamometer and intra-uterine pressure catheter for uterine contraction monitoring during term labor.
- Scientific TitleMonitoring contractions during labor: comparing real-time electrohysterography to internal and external tocodynamometry.
- ACRONYMW3-study
- hypothesisMonitoring contractions during labor can be challenging. Currently, external tocodynamometry and the intrauterine pressure catheter are used as monitoring technique. The external tocodynamometer is a safe option with poor accuracy, whereas an intrauterine pressure catheter provides a quantifiable measure but is invasive. We want to study the performance of a new monitoring system based on real-time electrohysterography: PUREtrace (Nemo Healthcare, Eindhoven, the Netherlands). Electrohysterography has several potential advantages: it is non-invasive, accurate, reliable and applicable on a continuous basis. Moreover, the EHG is potentially less sensitive to maternal obesity.
- Healt Condition(s) or Problem(s) studiedUterine contraction monitoring
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria: women with a singleton pregnancy and gestational age between 37 and 42 weeks, in active labor with a fetus in cephalic presentation, ruptured membranes and fetal scalp electrode. We will apply strict criteria regarding diagnosis of labor: a pregnant woman needs to have regular painful contractions at least three each ten minutes, and a fully effaced cervix with minimum 3 centimeters of dilation.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study: women under the age of 18 years old, women with a multiple pregnancy, women with signs of fetal distress (abnormal CTG requiring immediate intervention), women with a positive Group B streptococcus status in urine or vagina, and women with a positive hepatitis B/C or HIV serology. Contraindications to IUPC placement are uterine bleeding of undetermined origin, a suspected placenta praevia, vasa praevia, and signs of intrauterine infection (maternal fever >38C with fetal tachycardia >160 beats per minute). Contraindications to EHG placement are dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper, women in labor taking a shower or bath and women connected to external or implanted electrical stimulators.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 30-jul-2014
- planned closingdate1-aug-2016
- Target number of participants131
- InterventionsObservational diagnostic study of three tocographic methods recorded simultaneously during two hours of labor: 1. electrohysterography (EHG) 2. external tocodynamometry (TOCO) 3. intrauterine pressure catheter (IUPC). Postpartum, we ask women to fill out an evaluation questionnaire regarding patient satisfaction.
- Primary outcomeThe primary outcome measure is the sensitivity of electrohysterography to monitor contractions in pregnant women during term labor. Sensitivity is defined as the percentage of correctly identified contractions that were simultaneously detected by an intrauterine pressure catheter. Sensitivity of electrohysterography will also be compared with sensitivity of external tocodynamometry.
- Secondary outcomeBoth primary study parameters will be evaluated in a sub group of morbidly obese women. And sub analysis will also be performed to compare non-obese and obese, and to compare pregnant women with or without analgesia. Other performance characteristics are: positive predictive value, correlation and contractions consistency index. A Bland-Altman analysis with scatterplot will be carried out to determine the agreement between electrohysterography or external tocodynamometry with intrauterine pressure measurements. Finally, patient preference will be evaluated.
- TimepointsAn interim analysis will be performed after inclusion of 48 women.
- Trial web sitenot applicable
- statusstopped: trial finished
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsNot yet
- Brief summaryIn this observational prospective study, pregnant women in term active labor will be simultaneously monitored with EHG, TOCO and IUPC. The goal is to determine the sensitivity of EHG and to compare EHG with TOCO.
- Main changes (audit trail)
- RECORD12-jun-2016 - 23-aug-2016

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