Contractions uterine activity
Conditions
Interventions
None listed
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed