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Clinical Trials/NL-OMON40734
NL-OMON40734
Completed
Not Applicable

Observational study - Monitoring contractions during labor: comparing real-time electrohysterography to external and internal tocodynamometry - W3-study

Maxima Medisch Centrum0 sites131 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contractions
Sponsor
Maxima Medisch Centrum
Enrollment
131
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Sponsor
Maxima Medisch Centrum

Eligibility 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

  • 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.

Outcomes

Primary Outcomes

Not specified

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