To investigate the effect of implementing continuous antepartum eCTG monitoring at the OHC, on perinatal and maternal outcomes and obstetric care
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a composite of perinatal mortality or major neonatal morbidity until hospital
discharge. Major neonatal morbidity is defined as either: Intraventricular
hemorrhage (IVH) grade three or more, Periventricular leukomalacia (PVL) grade
two or more, Moderate or severe bronchopulmonary dysplasia (BPD), Necrotizing
enterocolitis (NEC) grade two or more, or Retinopathy of prematurity (ROP)
necessitating laser therapy.
Secondary outcome
Maternal mortality, neonatal morbidity, satisfaction for both patient and
caregiver, duration of pregnancy, switch of monitoring method, duration of
admission to the OHC, timing (planned or emergency) and number of obstetric
interventions (such as caesarean section), and admission and duration of
admission to the NICU (neonatal intensive care unit).
Additional objectives: The collected NFMS and demographic data will be used to
develop and verify a mathematical model for the prediction of time until
(preterm) birth, which may be used in clinical practice to reduce unnecessary
OHC admissions and facilitate a better timing of interventions. Furthermore,
data collected in this study (NFMS, accelerometric, annotated ultrasound) will
be used for the development and verification of a mathematical model for the
automated detection of fetal movements in NFMS data. This latter model might
provide new opportunities in non-invasive monitoring of fetal health.
Background summary
Pregnant women in need for maternal and/or fetal monitoring are hospitalized at
the obstetric high care (OHC) of Máxima Medical Center (MMC). They are
monitored for up to three times a day with conventional cardiotocography (CTG).
In the meantime they reside at the OHC, but the status of the fetus and uterine
activity (UA) is not monitored. Nemo Healthcare developed a wireless abdominal
electrode patch for measuring fetal heart rate (FHR) and UA: The Nemo Fetal
Monitoring System (NFMS). Previous research on non-invasive
electrophysiological CTG (eCTG) has yielded promising results in monitoring FHR
and UA both during pregnancy and labor. With the use of eCTG technology, safe
continuous 24/7 monitoring is possible, which is not possible with conventional
cardiotocography. We hypothesize that by introducing continuous antepartum eCTG
monitoring perinatal and maternal outcomes will improve
Study objective
To investigate the effect of implementing continuous antepartum eCTG monitoring
at the OHC, on perinatal and maternal outcomes and obstetric care
Study design
A single center prospective cohort intervention study with historical controls.
Intervention
Eligible women will be prospectively included in the cohort receiving standard
treatment: CTG monitoring intermittent up to three times a day. From these
eligible women, a random sample (464) of the prospective cohort (511) will be
offered to receive a new monitoring method: 24/7 eCTG monitoring with NFMS. In
order to strengthen the comparison between the two groups (eCTG and standard
treatment), additional data from 1400 women who received standard treatment in
2014-2019 will be collected retrospectively.
Study burden and risks
Participation in this study is expected not to cause any risk for the women or
fetus*, because if registration using the abdominal patch is insufficient, a
switch to the (intermittent) conventional CTG will be made which is available
at the OHC. From that moment on decisions will be based on the conventional CTG
monitoring system, which is standard care. The advantage of the NFMS is that it
is wireless (allowing women to move), non-invasive, safe, makes continuous
monitoring possible, and has the potential to improve maternal and neonatal
outcomes. There is a chance that participating women experience skin irritation
or minor allergic (local) reaction to the skin electrodes from the abdominal
patch. If this happens, it is possible to switch to standard care. No treatment
is necessary if skin irritation occurs.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
>=18 years old, Singleton pregnancy >=23+0 weeks of gestation,Requiring
hospitalization to the OHC for maternal or fetal surveillance, Parents wishing
for fetal monitoring
Exclusion criteria
Multiple pregnancy, insufficient knowledge of Dutch or English language
, Contraindications to abdominal patch placement (dermatologic diseases of the
abdomen precluding preparation of the abdomen with abrasive paper), women
connected to an external or implanted electrical stimulator (e.g. a pacemaker -
exclusion due to possible signal interference), Fetal and/or maternal cardiac
disease (i.e. arrhythmia, congenital defect), Treatment plan (with intervention
planned) already made before inclusion is completed, and women admitted with a
clinical diagnosis of sepsis with hypotension (i.e. septic shock).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82869.015.22 |