Intrapartum monitoring: a prospective observational cohort

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.

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.

Standard care until 6 weeks postpartum

None, standard care