Treatment for Fetal Growth Retardation

1
Effectiveness
1
Safety
Weill Cornell Medicine, New York, NY
Fetal Growth Retardation
Eligibility
18 - 65
Female
Eligible conditions
Fetal Growth Retardation

Study Summary

This study is evaluating whether a sample of cells from the cervix can be used to determine if a woman is pregnant.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Fetal Growth Retardation. Measurement will happen over the course of 6 weeks post pregnancy.

16 weeks post pregnancy
Occurrence of chromosomal anomalies detected via trophoblast cell analysis as compared to occurrence of chromosomal anomalies detected via preimplantation genetic testing (PGT), chorionic villi sampling (CVS), amniocentesis, or cytogenetic results.
6 weeks post pregnancy
Occurrence of chromosomal anomalies as detected via fetal genome analysis of trophoblast cells

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Groups

Control

This trial requires 70 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks post pregnancy
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 16 weeks post pregnancy for reporting.

Closest Location

Weill Cornell Medicine - New York, NY

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women 18 to 45 who achieve a pregnancy during study time period.
If pregnancy result in miscarriage, cytogenetic testing must be completed on the product of conception.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes fetal growth retardation?

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A small proportion of birthweight standard deviations above and below the median are associated with a known identifiable cause. However, because a large number of such patients do not have a single identifiable cause, even such patients should not be regarded as "at risk" for adverse pregnancy outcomes.

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Can fetal growth retardation be cured?

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There is no evidence in the published literature to support a change in prenatal screening guidelines to allow for the diagnosis of fetal intrauterine growth retardation and subsequent induction of termination.

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How many people get fetal growth retardation a year in the United States?

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Approximately 6,600 babies per year in the United States are born with FGR. This makes up about 1.1% of all babies in the United States. Fetal birth weight z-score greater than 3.3 at delivery is associated with long-term adverse outcomes for the children.

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What are common treatments for fetal growth retardation?

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In some cases, intrauterine growth retarded fetuses will be delivered by cesarean section. In other cases, postnatal care will be prescribed. The latter includes feeding tube, intravenous nutrition, and total parenteral nutrition. Treatment for fetal growth retardation may be more effective for some fetuses than for others.

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What is fetal growth retardation?

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Birth weight is positively correlated with maternal weight. Therefore, the birth weight of mothers with normal prepregnancy weight might be related mainly to the fetal weight since it is easy to imagine that a mother with an obese pregnancy and heavy infant (birth weight ≥10 - 16 kg) may have an obese newborn because of her maternal obesity. Birth weight increases with the increasing number of pregnancies and the increasing numbers of babies. Therefore, even a normal weight maternal could also have an obese baby with bigger head circumference. In conclusion, we think that [heavier baby] with large or obese head circumference might not be a normal fetal growth retardation but [a normal fetal growth retardation].

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What are the signs of fetal growth retardation?

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Growth retardation has a variety of potential symptoms, and one of the first signs is prenatal growth. Most cases develop in the absence of known risk factors. The mainstay of management is a detailed antenatal examination, regular ultrasound scanning, and fetal monitoring by cardiotocography. Treatment is geared towards identifying the underlying cause. Often, treatment of the underlying abnormality will improve the fetal growth. Those women who have problems with their weight, or who have an abnormal vaginal bleeding, should be questioned about recent birth histories. It is suggested that a blood or amniotic fluid aspirate may be required. If ultrasound is positive, an ultrasound guided blood sample is recommended in some circumstances, to give a more definitive diagnosis.

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Does treatment improve quality of life for those with fetal growth retardation?

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Even in this limited study, women receiving growth hormone showed higher scores on all QOL instruments. These scores correlated with patient satisfaction scores and with growth rate at the time of referral.

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Has treatment proven to be more effective than a placebo?

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The data from this meta-analysis supports the evidence for the effectiveness of conventional treatment in improving growth and growth velocity during the first six months of growth and in improving motor development at six and 12 months. There is insufficient evidence to suggest that early growth and motor development can be improved with the aim of preventing permanent neurological abnormalities.

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How serious can fetal growth retardation be?

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As fetal growth retardation progresses, fetal death becomes almost certain, regardless of the underlying cause. The current recommendation is that fetuses should be delivered at gestational ages of 22 to 24 weeks in the absence of medical indications for labor induction or cesarean section. However, fetal death can occur after a gestational age of 16 weeks without a medical indication.

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Is treatment safe for people?

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With low to moderate risk of fetal growth problem, the safety of the treatment for pregnant women is confirmed. Appropriate training and good-quality surveillance for fetal growth retardation would prevent the risks of poor pregnancy results and decrease the risk of miscarriage.

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Who should consider clinical trials for fetal growth retardation?

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Current knowledge of potential problems with FGR does not allow clinicians with an interest in managing FGR to make clinical trial decisions as long as the patient is still actively undergoing pregnancy. Clinicians' expertise and interest in FGR is not the sole criterion for participation in clinical trials for FGR.

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What is treatment?

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Treatment options are many; there's no short cuts. There's some research into prenatal gene therapy to treat certain conditions such as Duchenne muscular dystrophy and Friedreich's ataxia. There have been trials and results on prenatal treatment, but there have not been results yet of the gene therapy treatments on pregnant women or their newborns. This is a new field still being researched to help the pregnant mothers and newborn babies with these chronic disease. There's a new field in preimplantation genetic diagnosis to help a woman with an inherited disease to have her own child free of their inherited disease. Genetic testing to decide the best option to ensure future health, in the case of preimplantation genetic diagnosis.

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