Preterm Delivery Clinical Trial
Official title:
A Randomized Double-Blinded Study Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome
The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks' gestation.
This is a randomized double-blinded placebo-controlled trial. The objective of this study is
to evaluate the impact of one versus two courses of antenatal steroids on the incidence of
major neonatal morbidity including respiratory distress syndrome in patients delivering
prior to 34 weeks' gestation in a randomized prospective fashion.
Preterm delivery occurs in approximately 10% of all deliveries in the United States. Preterm
birth is the cause of 75% of neonatal mortality not mentioning the significantly increased
morbidity from respiratory distress syndrome, intraventricular hemorrhage, necrotizing
enterocolitis, and sepsis. Numerous studies have evaluated the safety and efficacy of
antenatal corticosteroid (ACS) administration in threatened preterm labor.
National Institutes of Health (NIH) first consensus conference in 1994 evaluated the
research in this field. Conclusions included the clear evidence that antenatal
corticosteroids decrease the incidence of RDS in infants born at 29-34 weeks gestation, with
a decrease in RDS severity for infants born at 24-28 weeks gestation and a decrease in the
incidence of intraventricular hemorrhage in infants born at 24-28 weeks gestation without
harm to mother or fetus. Their recommendation was to give a single course of corticosteroids
to all pregnant women between 24 and 34 weeks gestation who are at risk of preterm delivery
within 7 days.
Since the studies on the duration of the effects of antenatal corticosteroids in the fetus
are not conclusive, many obstetricians repeat corticosteroids weekly or bi-weekly to
patients continuing to be at risk for preterm delivery. Lacking scientific evidence, many
investigators have performed retrospective analyses regarding the effects of single-course
versus multiple-course antenatal corticosteroids.
The NIH consensus panel reconvened in 2000 and concluded that studies regarding repeated
courses of corticosteroids are suggestive of possible benefits, especially in reduction of
RDS, however, design flaws limit their validity.
The more recent publication from Caughey and Parer examined the literature for evidence
regarding a dose response of the benefits and detriments of antenatal corticosteroids. Based
on their complex mathematical analysis they recommend all fetus' between 24 and 34 weeks'
gestation at risk for preterm delivery should be given a first course of ANC. If the risk of
preterm delivery persists the next course should be given 2 weeks later, for a maximum of
two courses. Consistent with all previous articles, the call for a well designed randomized,
controlled trial is made.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03304782 -
Fitbit Activity Tracker to Predict Risk of Preterm Birth
|
||
Recruiting |
NCT02420743 -
Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery
|
||
Completed |
NCT01119963 -
Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)
|
Phase 2/Phase 3 | |
Completed |
NCT01665378 -
Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes
|
N/A | |
Completed |
NCT00141908 -
Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate
|
Phase 2 | |
Recruiting |
NCT05278130 -
Serial Screening and Treatment of Bacterial Vaginosis Trial
|
N/A | |
Terminated |
NCT03596125 -
Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)
|
Phase 2/Phase 3 | |
Recruiting |
NCT03123926 -
Spontaneous Preterm Birth Marker Test
|
N/A | |
Completed |
NCT01353807 -
Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health
|
N/A | |
Terminated |
NCT02545127 -
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
|
Phase 2 | |
Completed |
NCT02371356 -
Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health
|
||
Active, not recruiting |
NCT01009723 -
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
|
N/A | |
Completed |
NCT00883324 -
Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum
|
N/A | |
Completed |
NCT00615550 -
PREGNANT Short Cervix Trial
|
Phase 3 | |
Completed |
NCT02694679 -
Randomized Controlled Trial of Social Network Targeting in Honduras
|
N/A | |
Completed |
NCT01031017 -
Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies
|
Phase 4 | |
Completed |
NCT00331695 -
Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
|
Phase 4 | |
Completed |
NCT00329914 -
Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?
|
Phase 2 | |
Completed |
NCT01818518 -
Neonatal Outcome by Reason for Delivery
|
||
Completed |
NCT04637880 -
25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders
|