Observational study - Monitoring contractions during labor: comparing real-time electrohysterography to external and internal tocodynamometry
- Conditions
- Contractionsuterine activity10010273
- Registration Number
- NL-OMON40734
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 131
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.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure will be sensitivity of real-time<br /><br>electrohysterography to monitor contractions in pregnant women during labor.<br /><br>Sensitivity is defined as the percentage of correctly identified contractions<br /><br>that were simultaneously detected by an intrauterine pressure catheter.<br /><br>Sensitivity of electrohysterography will also be compared with sensitivity of<br /><br>external tocodynamometry. An interim analysis will be performed after inclusion<br /><br>of 48 women. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Both primary study parameters will be evaluated in morbidly obese women. And<br /><br>sub analysis will be performed to compare non-obese and obese, and to compare<br /><br>pregnant women with or without analgesia. Other performance characteristics<br /><br>are: positive predictive value, correlation and contractions consistency index.<br /><br>A Bland-Altman analysis with scatterplot will be carried out to determine the<br /><br>agreement between electrohysterography or external tocodynamometry with<br /><br>intrauterine pressure measurements. Finally, patient preference will be<br /><br>evaluated. </p><br>