The main outcome measure is the sensitivity of real-time electrohysterography for detecting contractions, using an intrauterine pressure catheter as reference. Furthermore, the accuracy of EHG will be compared to external tocodynamometry for…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be sensitivity of real-time
electrohysterography to monitor contractions in pregnant women during 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. An interim analysis will be performed after inclusion
of 48 women.
Secondary outcome
Both primary study parameters will be evaluated in morbidly obese women. And
sub analysis will 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.
Background summary
Monitoring 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. An innovative technique to monitor uterine activity,
electrohysterography (EHG), is developed and extensively evaluated in a
collaboration between University of Technology Eindhoven and Máxima Medical
Center. 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 less sensitive to maternal obesity.
Study objective
The main outcome measure is the sensitivity of real-time electrohysterography
for detecting contractions, using an intrauterine pressure catheter as
reference. Furthermore, the accuracy of EHG will be compared to external
tocodynamometry for monitoring contractions during labor. A subset analysis
will be performed of morbidly obese women. Another goal is to compare
sensitivity of both external methods in pregnant women with or without
analgesia, and with or without obesity. Additional secondary outcome will be
patient preference.
Study design
Observational diagnostic study of three tocographic methods recorded
simultaneously during two hours of labor:
1. real-time electrohysterography (EHG)
2. external tocodynamometry (TOCO)
3. intrauterine pressure catheter (IUPC)
Only the intrauterine pressure output for uterine activity will be displayed at
the nurses and obstetricians. Postpartum, we ask women to fill out an
evaluation questionnaire regarding patient satisfaction.
Study burden and risks
The investigational electrohysterography and the external tocodynamometer are
non-invasive methods to monitor uterine activity during labor. Rare
complications have been reported regarding the IUPC, which are thought to be
related to improper placement. These include placental damage and uterine wall
perforation. No data is available on the incidence of these complications.
However, in a recent Cochrane review comparing internal (n=977) and external
tocodynamometry (n=968) there were no complications reported from the use of
the IUPC. Moreover, the IUPC is still widely used in daily practice in many
obstetrical wards in the Netherlands. The protocol for IUPC placement will
include ultrasound guided placement to minimize the risk of improper placement.
Only midwives, residents and gynecologist that have experience in placing
IUPC*s will perform the placement of an IUPC. Unexperienced professionals will
need to be trained before using IUPC*s. The questionnaire on patient preference
will take less than 10 minutes.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
In 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 criteria
A 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 known positive GBS (Group B Streptococcus)-status in the urine or vagina, and women with a positive hepatitis B, hepatitis 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, 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.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL48951.015.14 |
| OMON | NL-OMON23485 |