on-invasive electrophysiological monitoring on the obstetric high

Recruiting

Conditions: Perinatal mortality and morbidity - Health condition of the (unborn) child
10028920

Registration Number: NL-OMON56122

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 511

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a composite of perinatal mortality or major neonatal morbidity until hospital<br /><br>discharge. Major neonatal morbidity is defined as either: Intraventricular<br /><br>hemorrhage (IVH) grade three or more, Periventricular leukomalacia (PVL) grade<br /><br>two or more, Moderate or severe bronchopulmonary dysplasia (BPD), Necrotizing<br /><br>enterocolitis (NEC) grade two or more, or Retinopathy of prematurity (ROP)<br /><br>necessitating laser therapy.</p><br>

Secondary Outcome Measures