Early Onset Intrauterine Growth Restriction. Maternal care for known or suspected poor fetal growth
Conditions
Interventions
Intervention 1: Intervention group: In addition to standard antenatal care (calculation of gestational age based on the first day of the last menstrual period and previous ultrasound examinations
maternal history taking regarding nutritional status and weight gain, systemic diseases, and complaints of fluid leakage
careful fetal heart rate auscultation every 4 hours
ultrasonography to assess amniotic fluid volume and fetal activity
evaluation for preeclampsia
administration of corticosteroids when indicated
and prenatal counseling), patients in this group receive enoxaparin sodium 4000 IU (40 mg in 0.4 mL) administered as a once-daily subcutaneous injection.The study drug is Enoxaparin Sodium, manufactur
and prenatal counseling), without the use of enoxaparin.
Sponsors
Qazvin University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Mother's age between 18 and 40 years Single pregnancy Gestational age between 24 and 34 weeks Confirmation of IUGR diagnosis based on Doppler ultrasound Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Multiple pregnancy Presence of chromosomal or structural abnormalities in the fetus Severe underlying diseases (such as uncontrolled blood pressure, severe diabetes, kidney and liver diseases) Contraindications to enoxaparin (such as severe allergy to heparin or active bleeding) Abuse of drugs, alcohol or cigarettes Infectious diseases such as cytomegalovirus, toxoplasmosis, rubella or syphilis Patients who have received enoxaparin for less than 7 days Patients who are taking aspirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serial changes in fetal umbilical artery and middle cerebral artery Doppler indices (UA-PI and MCA-PI) as indicators of placental function and fetal circulatory adaptation. Timepoint: The primary outcome will be measured at baseline (at study enrollment) and through serial Doppler assessments performed weekly in cases with normal Doppler findings and two to three times per week in cases with abnormal Doppler findings, from enrollment until delivery or up to 36 weeks of gestation, whichever occurs first. The final assessment will be considered at the last Doppler examination prior to delivery. Method of measurement: The primary outcome measurement tool is color Doppler ultrasonography. Doppler assessment of the fetal umbilical artery and middle cerebral artery, including measurement of the pulsatility index (PI), will be performed using a Sono ESCAPE ultrasound system (manufactured in China) equipped with a 3.5-MHz convex transducer. All measurements will be conducted by a trained obstetrician under standardized conditions. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMelika Gholampour
Qazvin University of Medical Sciences
Outcome results
None listed