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Role of micronised allylestrenol in fetal growth restriction

ROLE OF MICRONIZED ALLYLESTRENOL IN FETAL GROWTH RESTRICTION

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2012/03/002503
Enrollment
120
Registered
2012-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Fetal Growth Restriction

Interventions

Intervention1: Micronised Allylestrenol (5 mg) tablets: Micronised Allylestrenol (5 mg), 2 tablets twice daily from diagnosis of FGR till 37th completed weeks of gestation or till the preganancy termi

Sponsors

Walter Bushnell Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Singlenton pregnancy 2. Preganant women from the day of diagnosis of FGR but within 34 completed weeks of gestation 3. Criteria for diagnosis of FGR: Clinical + One parameter of USG (a) Clinical: Discrepancy of at least 4 weeks or more or 4 cm by SFH (Symphysio fundal height) (b) USG: - Abdominal circumference (AC) 2 S.D from mean for gestational age - Amniotic fluid index (AFI) 8 cm - Femur length to abdominal circumference (FL/AC) ratio 24 - Head circumference to abdominal circumference ratio 1 - Estimated Fetal weight 2 S.D from mean for gestational age 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant women aged 18 and 35 years 2. Patients unwilling to give consent 3. Premature rupture of membranes 4. Any congenital anomaly in the fetus detected on USG 5. Patient on any other medication for FGR (Beta-sympathomimetics like Isoxpurine, Ritodrine, Aspirin etc.) 6. Symmetric FGR 7. Women with TORCH infections 8. Multiple pregnancy

Design outcomes

Primary

MeasureTime frame
1. Gestational age at delivery 2. Birth weight of the baby 3. APGAR scoreTimepoint: 1. Patients will be evaluated every 2 weeks in 8 weeks study period 2. Final outcome at delivery

Secondary

MeasureTime frame
1. Mode of delivery 2. Placental weight 3. NICU admissions 4. Adverse effects of drugsTimepoint: 1. Patients will be evaluated every 2 weeks in 8 weeks study period 2. Final outcome at delivery

Countries

India

Contacts

Public ContactDr Sumita Mehta
rajaram.shalini@gmail.com91-9868399750

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026