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ID
Source
Brief title
Health condition
Every patient who delivers at our clinic
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Rationale: There are two possibilities for non-invasive fetal monitoring: the conventional cardiotocogram (CTG) using Doppler ultrasound (DU) for the fetal heart rate (FHR) and external tocography (TOCO) for uterine contractions or the non-invasive fetal electrocardiography (NI-fECG) using electrical waveforms of the fetal heart to register FHR and electrohysterography (EHG) for uterine contractions. Currently the conventional CTG is used for fetal monitoring during labour.
Objective: The aim of this study is to prospectively collect data to record maternal and neonatal outcomes of fetal monitoring during labour by using the conventional CTG.
Study design: This is a multi-center prospective observational cohort study.
Study population: Pregnant women with fetal monitoring during delivery, carrying at least one living fetus. These women will act as a control group for an implementation study for the NI-fECG, which will be performed later this year. After inclusion of the first 200 women, we continue to include women as part of a large prospective observational multicenter cohort on fetal monitoring during labor and obstetrical outcomes. 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.
Intervention (if applicable): Standard care. All women during delivery will receive transducers placed on the abdomen: one above the fetal heart to monitor FHR (DU) and the other at the fundus of the uterus (TOCO) to measure frequency of contractions. A FSE is placed when the membranes are ruptured and FHR monitoring is insufficient by using DU. To obtain complementary fetal information during labor, FBS can be needed and performed.
Main study parameters/endpoints: The primary outcomes are maternal and neonatal outcomes. Maternal outcomes: the percentage of episiotomy and its indication, the percentage of episiotomy and its indication, spontaneous vaginal deliveries, the percentage and indications of operative deliveries (vacuum extractions or caesarean section). Neonatal outcomes: percentage of FBS during delivery, gender, birth weight (dysmaturity and macrosomia), admission to neonatal ward with reason, Apgar score (<7 after 5 minutes), pH in umbilical artery and vein, severe metabolic acidosis (pH < 7.00 and base deficit ≥ 12 mmol/L). Secondary outcomes are the percentage of FSE that was used and how often FBS was performed. Complications during delivery: shoulder dystocia, intrapartum maternal fever, eclampsia, postpartum hemorrhage, thrombosis, wound infection, endometritis, mastitis.
Study objective
These women will act as a control group for an implementation study for the non-invasive fetal ECG, which will be performed later this year.
Study design
Standard care until 6 weeks postpartum
Intervention
None, standard care
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7948 |
| Other | METC Maxima MC Veldhoven : METC L19.039 / N19.032 |