Study of Enoxaparin Treatment in Pregnant Women with Early Fetal Growth Restriction

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What is this study about?

This study focuses on Fetal Growth Restriction, a condition where an unborn baby is smaller than expected or growing at an abnormal rate during pregnancy. The research examines the effectiveness of enoxaparin sodium, a medication given as an injection under the skin, in treating early stages of this condition. This medication belongs to a group of drugs called low molecular weight heparins, which are commonly used to prevent blood clots.

The purpose of this study is to determine if this treatment can help extend the time babies with growth restriction can stay in the womb before delivery is necessary. The medication being tested is Enoxaparin Rovi, which comes in pre-filled syringes containing 4,000 international units (40 mg) of the active substance. Participants will receive daily injections under the skin for up to 24 weeks during their pregnancy.

During the study, various aspects of both the mother’s and baby’s health will be monitored through regular check-ups. These include checking the blood flow to the baby and through the placenta, tracking the baby’s growth, and monitoring the mother’s health throughout pregnancy. The study will also look at important outcomes such as the baby’s birth weight, overall health at birth, and any complications that may occur during pregnancy or delivery.

1 Initial confirmation of eligibility

Your eligibility for the study will be verified based on the following criteria:

– You must be at least 18 years old

– You must have a single pregnancy (not twins or multiple)

– Your pregnancy must be diagnosed with early fetal growth restriction (a condition where the baby is smaller than expected)

2 Treatment administration

You will receive Enoxaparin (4,000 UI/40 mg) through subcutaneous injection (an injection under the skin)

The medication comes in a pre-filled syringe containing 0.4 mL of solution

3 Monitoring during pregnancy

Regular ultrasound examinations will be performed to check:

– Blood flow in the umbilical cord

– Blood flow in the baby’s brain

– Blood flow in the uterine arteries

Your body mass index (BMI) will be measured

4 Delivery and newborn assessment

At delivery, the following will be documented:

– Baby’s weight

– Baby’s health scores (Apgar score at 5 minutes)

– Type of delivery

– Any complications during delivery

5 Post-delivery follow-up

After delivery, the following will be monitored:

– Any need for intensive care for the baby

– Your recovery and any complications

– Examination of the placenta

Who Can Join the Study?

  • Must be 18 years or older
  • Must be able to understand and provide informed consent for participation in the study
  • Must be pregnant with a single baby (not twins or multiple pregnancies)
  • Must have a confirmed diagnosis of early fetal growth restriction (a condition where the baby is not growing at the expected rate during pregnancy)
  • Must be female
  • The pregnancy must be viable (the baby shows signs of life and development)
  • The diagnosis must be confirmed at the study facility according to current medical standards

Who Cannot Join the Study?

  • Active or recent significant bleeding (within the last month)
  • Blood clotting disorders that increase risk of bleeding
  • Known allergic reaction to enoxaparin (blood-thinning medication) or similar medications
  • Severe kidney disease (as it affects how the medication is processed)
  • Current use of other blood-thinning medications
  • Multiple pregnancy (carrying more than one baby)
  • Placental abruption (when the placenta separates from the uterus wall)
  • Active liver disease or decreased liver function
  • History of heparin-induced thrombocytopenia (a condition where blood-thinning medications cause low platelet counts)
  • Planned delivery within the next week
  • Participation in another clinical trial within the past 30 days
  • Any condition that, in the opinion of the investigator, would make participation unsafe
  • Inability to comply with study procedures or follow-up visits
  • Age under 18 years

Where you can join this trial?

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Recruiting
18.07.2022

Trial locations

Investigated drugs:

Enoxaparin is a blood-thinning medication (low molecular weight heparin) that helps prevent blood clots. In this trial, it is being studied for its potential to help improve fetal growth during pregnancy. The medication works by making the blood less likely to form clots, which may help improve blood flow to the developing baby through the placenta.

Heparin (low molecular weight) belongs to a class of medications called anticoagulants. It is commonly used to prevent and treat blood clots. In pregnancy-related research, it is being investigated for its potential benefits in cases where the baby is not growing as expected in the womb. The medication is typically given as an injection under the skin.

Fetal Growth Restriction – A condition where an unborn baby is not growing at the expected rate during pregnancy. The baby’s estimated weight falls below the normal range for its gestational age, typically below the 10th percentile. This condition can occur due to problems with the placenta, which may not provide enough nutrients and oxygen to the developing fetus. During fetal growth restriction, the baby may adapt by directing most of its limited resources to vital organs like the brain and heart. The condition can develop at any stage of pregnancy but is more commonly identified in the third trimester through routine measurements and ultrasound scans.

Trial ID:
2024-516572-15-00
Protocol code:
1375_RCF_MAC
NCT ID:
NCT04762992
Trial Phase:
Therapeutic confirmatory (Phase III)

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