Obstetric Labor Complications, Ultrasonography, Doppler
Conditions
Brief summary
1. Assess differences in flow patterns in the fetal cerebral blood vessels within 24 hours before delivery between fetuses with a normal vs. adverse perinatal outcome. 2. Explore maternal and/or fetal characteristics that might influence technical feasibility of doppler sonography of the fetal cerebral blood vessels in early labor at term. 3. Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.
Interventions
OTHERUltrasound examination in early labor
Combined trans-abdominal and trans-perineal ultrasound examination
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy. * Term gestation (37-42 weeks). * Fetus in cephalic presentation. * No known fetal chromosomal or (severe) congenital anomaly. * Normally grown fetus (ultrasound scan demonstrating normal fetal growth between 30-37 weeks of gestation, defined as an estimated fetal weight/abdominal circumference \> 10th centile or crossing \<2 quartiles compared to earlier growth ultrasound). * Absence of pre-existing doppler or amniotic fluid abnormalities. * Normal fetal heart rate tracing / CTG (excluding pre-existing hypoxia). * Admission in early spontaneous labor or induction of labor with expected delivery \< 24 hours. * Maternal age \>= 18 years * Willing to give written informed consent.
Exclusion criteria
* Advanced labor (\> 4cm of cervical dilatation) at the time of admission on the labor ward. * Severe pre-existing chronic maternal medical condition or poor obstetric history/antenatal complications associated with increased risk of adverse perinatal outcome (non-exhaustive e.g.: uncontrolled chronic hypertension, severe pre-eclampsia, uncontrolled (gestational) diabetes, maternal sepsis, major antepartum haemorrhage, intra-uterine infection, prolonged rupture of membranes \> 18 hours, etc.). * Intra-uterine fetal demise / death. * Prelabour rupture of membranes with meconium-stained amniotic fluid. * Patients not fulfilling all the inclusion criteria or refusing to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3 | VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours. |
Secondary
| Measure | Time frame |
|---|---|
| Differences in other doppler parameters (PI VA, PI MCA, CPR) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3. | VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours. |
| Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively. | Assessed in early labor (=< 4cm of cervical dilatation) |
Countries
Belgium
Contacts
Primary ContactBram Packet
Outcome results
None listed