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Intrapartum monitoring: a prospective observational cohort

Intrapartum monitoring: a prospective observational cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25099
Enrollment
3000
Registered
2019-03-18
Start date
2019-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Every patient who delivers at our clinic

Interventions

None, standard care

Sponsors

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria: None, monitoring standard care

Design outcomes

Primary

MeasureTime frame
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. 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). Neonatal outcomes: FBS during delivery, birth weight, gender, Apgar score, admission to a neonatal ward, pH in umbilical artery and vein.

Secondary

MeasureTime frame
The rate of deliveries in which placement of FSE was used, and how often FBS was performed. Complications during delivery and postpartum: shoulder dystocia, intrapartum maternal fever, eclampsia, postpartum hemorrhage, thrombosis, wound infection, endometritis, mastitis. 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.

Contacts

Public ContactDaisy van der Woude

Maxima Medical Center Veldhoven

daisyvanderwoude@hotmail.com040-8888384

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)