Intrapartum monitoring: a prospective observational cohort
Recruiting
- Conditions
- Every patient who delivers at our clinic
- Registration Number
- NL-OMON25099
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3000
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: pregnant women who are admitted to the labor ward because of (induction of) labor or postpartum women who delivered at the labor ward with fetal monitoring during delivery, carrying at least one living fetus. Patients are only included after oral and written informed consent.
Exclusion Criteria
None, monitoring standard care
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main goal of this prospective observational study is to collect data to record maternal and neonatal outcomes of fetal monitoring during labour by using the conventional CTG (DU or FSE and TOCO). The collected data will be control data for an implementation study for the NI-fECG, which will be performed later this year.<br><br>Maternal outcomes: episiotomy and its indication, spontaneous vaginal deliveries and operative deliveries (vacuum extractions or caesarean section) with indication (fetal distress and/or failure to progress).<br>Neonatal outcomes: FBS during delivery, birth weight, gender, Apgar score, admission to a neonatal ward, pH in umbilical artery and vein.
- Secondary Outcome Measures
Name Time Method The rate of deliveries in which placement of FSE was used, and how often FBS was performed.<br>Complications during delivery and postpartum: shoulder dystocia, intrapartum maternal fever, eclampsia, postpartum hemorrhage, thrombosis, wound infection, endometritis, mastitis.<br><br>This study serves as an important step towards prospective observational collection of data concerning monitoring during delivery on a larger scale. In addition, big data will provide reliable results concerning outcomes of obstetrical care in different subgroups in secondary and tertiary obstetric clinics.