Fetal Surveillance, Intrauterine Growth Restriction
Conditions
Keywords
Intrauterine Growth Restriction, fetal surveillance, fetal doppler, fetal growth
Brief summary
This study will be undertaken to determine whether the frequency of fetal surveillance can be safely reduced from bi-weekly to weekly in the case of fetusus with intrauterine growth restriction.
Detailed description
In this prospective randomized study, the cases whose fetal weight predicted by ultrasonography (USG) between the 28th and 37th weeks of gestation are below 10percentile according to the World Health Organization (WHO) normograms. The cases will be divided into two groups as group 1:weekly and group 2:bi-weekly (twice-weekly) The cases will be evaluated by fetal Doppler, amniotic fluid volume, nonstress test (NST) and maternal preeclampsia tests.Maternal severe hypertension/preeclampsia, category 3 NST, oligohydramnios (after 37 weeks amniotic fluid index \<5; after 34 weeks single deepest pocket \<2 cm) ,pathological doppler (before 34 weeks reverse flow in an umbilical artery , after 34 weeks absent end-diastolic flow in an umbilical artery) in cases of birth decision will be taken. Cases without the above mentioned complications will be delivered between 38 weeks 3 days and 39 weeks.
Interventions
PROCEDUREweekly
fetal surveillance frequency
PROCEDUREbi-weekly
fetal surveillance frequency
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 28-37 weeks pregnant women with estimated fetal weight below 10 percentile * singlton pregnancy
Exclusion criteria
* maternal preeclampsia * maternal systemic disease (pregestational diabetes, gestational diabetes mellitus a2, antiphospholipid antibody syndrome, chronic kidney disease) * oligohydramnios (after 34 weeks amniotic fluid index \<5; before 34 weeks single deepest pocket \<2 cm) * pathological doppler (high umbilical artery resistance index, absence of end-diastolic flow velocity in the umbilical artery, reverse flow in the umbilical artery, brain sparing effect in middle cerebral artery, abnormal ductus venosus flow)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neonatal hospital stay | 3 months | duration of neonatal hospital stay (days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| antenatal hospital stay | 3 months | duration of antenatal hospital stay (days) |
Other
| Measure | Time frame | Description |
|---|---|---|
| acidosis | 24 hours | fetal acidosis (normal cord-blood pH ranges from 7.14 to 7.4 during labor, values below 7.14 are considered to be acidosis) |
| gestational age at delivery | 24 hours | gestational age at delivery as days (e.g. 261days) |
| cesarean delivery | 24 hours | The number of births by cesarean section |
| perinatal death | 3 months | The number of perinatal deaths. Perinatal death is a fetal death (stillbirth) or an early neonatal death (first 24 hours after birth) |
| neonatal hospital stay | 3 months | duration of neonatal hospital stay (days) |
Countries
Turkey (Türkiye)
Contacts
Primary Contacttaha takmaz, MD
Backup Contactserdar kutuk, MD
Outcome results
None listed