Advertisement

Topics

Repeat Antenatal Steroids Trial

2014-07-23 21:56:00 | BioPortfolio

Summary

A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.

Description

After the NICHD Consensus Development Conference in 1994, the antenatal administration of antenatal corticosteroids (betamethasone or dexamethasone) for prevention of death and the serious morbidities associated with preterm birth has become an accepted standard in American obstetric practice. Studies have shown that maximum beneficial effect occurs when the fetus is delivered within 7 days of antenatal steroid administration. The efficacy and safety of a single course of corticosteroids has been substantiated but it is unknown whether repetitive dosing has similar efficacy or what the maternal, fetal and neonatal risks are. Repeat courses of steroids are often administered. Two popular regimens exist for the patient who remains undelivered more than one week after initial therapy but who remains at risk for preterm birth. In one, steroids are repeated weekly until 34 weeks gestation, while in the other, steroids are only given once.

This multicenter trial is testing the safety and efficacy of weekly administration of antenatal steroids. Twenty four hundred women < 32.0 weeks gestation who are at risk for spontaneous preterm delivery and remain pregnant at least seven days after an initial course of corticosteroids are being randomized to either weekly courses of masked study drug (betamethasone or placebo) for 4 weeks or delivery, whichever comes first. Patients are asked about side effects at the weekly visits and samples of maternal blood at randomization and delivery are collected. Cord blood and placentas are also collected. Cranial ultrasounds are done on all neonates. On a subgroup of patients, an adrenocorticotrophic hormone (ACTH) stimulation test is being performed and an auditory brainstem response (ABR) performed. All infants attend a follow-up visit at 18 to 22 months corrected age where certified examiners, masked to study group assignment, collect physical and neurological data. The Bayley Scales of Infant Development will also be administered. A subgroup of infants will be seen at 36 months to administer the Intelligence scale from the McCarthy Scales of Children's Abilities.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Complications, Pregnancy

Intervention

Betamethasone

Location

University of Alabama
Birmingham
Alabama
United States
35294

Status

Terminated

Source

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:56:00-0400

Clinical Trials [917 Associated Clinical Trials listed on BioPortfolio]

Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

We hope to clarify how betamethasone affects glucose levels in the mother in the days after receiving the drug. This understanding will hopefully allow us to better anticipate the risk of ...

Pharmacokinetics (PK) and Modeling of Betamethasone Therapy in Threatened Preterm Birth

Respiratory distress syndrome (RDS) is a life-threatening condition for premature neonates. Antenatal glucocorticoids have been used clinically in women with threatened preterm birth to ac...

India Dexamethasone and Betamethasone

An open label, randomized, two-period, crossover, study to compare the pharmacokinetics and pharmacodynamics of single dose Dexamethasone and Betamethasone administered orally and intramus...

Betamethasone Dosing Interval - 12 or 24 Hours?

The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.

Efficacy and Safety of Calcipotriene/Betamethasone Gel/Ointment in Psoriasis

Patients will receive either a gel containing both calcipotriene plus betamethasone or gel with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this time al...

PubMed Articles [2565 Associated PubMed Articles listed on BioPortfolio]

Pregnancy Complications Associated With Maternal Hypothyroidism: A Systematic Review.

Hypothyroidism is one of the most prevalent diseases in pregnancy, but there is no consensus about its management in pregnant women.

Impact of intrauterine exposure to betamethasone on the testes and epididymides of prepubertal rats.

Therapy with betamethasone, a synthetic glucocorticoid, is used in cases of preterm birth risk, in order to promote fetal lung maturation, and decrease neonatal mortality and morbidity. However, late ...

Inherited Thrombophilia and Pregnancy Complications: Should We Test?

Recurrent miscarriages and pregnancy-related complications cause significant stress to couples looking for successful pregnancy outcome as well as to health care professionals. There is conflicting ev...

Antenatal exposure to betamethasone induces placental 11β-hydroxysteroid dehydrogenase type 2 expression and the adult metabolic disorders in mice.

Antenatal overexposure to glucocorticoids causes fetal intrauterine growth restriction (IUGR) and adult metabolic disorders. 11β-hydroxysteroid dehydrogenase (11β-HSD) 1 and 2 are key enzymes for gl...

Study of transected sciatic nerve repair by biodegradable membrane and betamethasone in adult albino wistar rats.

One of the major injuries of the nervous system is that of peripheral nerves. Although peripheral nerves show some capacity of regeneration after injury, the extent of regeneration is not remarkable. ...

Medical and Biotech [MESH] Definitions

Round-shaped structure usually located in the upper fundus of the UTERUS in early pregnancy. It comprises EMBRYO; AMNIOTIC FLUID; and YOLK SAC. It is visible in PRENATAL ULTRASONOGRAPHY by the fifth week of pregnancy. Its size is often used to determine and monitor GESTATIONAL AGE; FETAL GROWTH; and PREGNANCY COMPLICATIONS.

Conditions or pathological processes associated with pregnancy. They can occur during or after pregnancy, and range from minor discomforts to serious diseases that require medical interventions. They include diseases in pregnant females, and pregnancies in females with diseases.

The co-occurrence of pregnancy and NEOPLASMS. The neoplastic disease may precede or follow FERTILIZATION.

The co-occurrence of pregnancy and an INFECTION. The infection may precede or follow FERTILIZATION.

The co-occurrence of pregnancy and parasitic diseases. The parasitic infection may precede or follow FERTILIZATION.

More From BioPortfolio on "Repeat Antenatal Steroids Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial