Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes

Premature Birth Clinical Trial

— ACSinPROM  

Official title:

A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469519
• Other study ID #: OBX0034
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 3, 2016
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2022
• Source: Pediatrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.

Description:

This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: October 31, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants age 18 years or older

• 24w0d to 32w6d weeks gestation

• Singleton pregnancy

• Received first course of ACS at or prior to 31w6d gestation

• Began first course of ACS at least 7 days ( =/> 168 hours) prior to randomization

• Expectant management planned

• Premature Ruptured membranes (PROM) before onset of labor

Exclusion Criteria:

• Known major fetal anomalies

• Multiple gestation

• Not a candidate for expectant management

• Clinical chorioamnionitis (two or more of the following: temperature > 38.0 degrees centigrade; uterine tenderness; foul smelling vaginal discharge or amniotic fluid; maternal tachycardia >100 bpm; fetal tachycardia >160 bpm; maternal White Blood Cell (WBC) count >20 X 109/L; C-Reactive Protein (CRP) > 5.9

• Already receiving corticosteroids for another condition

• Any contraindications to the maternal use of corticosteroids

Related Conditions & MeSH terms

• Premature Birth
• Rupture

Intervention

Drug:
• Betamethasone - ACTIVE
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.

Other:
• Normal Saline - PLACEBO
normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses

Locations

Country	Name	City	State
United States	Presbyterian/St Luke's Hospital	Denver	Colorado
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	University of South Alabama Medical Center	Mobile	Alabama
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Phoenix Perinatal Associates	Phoenix	Arizona
United States	Good Samaritan Hospital	San Jose	California
United States	Swedish Medical Center	Seattle	Washington
United States	Lousiana State University Health Science	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pediatrix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Neonatal Morbidity	Composite Neonatal Morbidity includes any one or more of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or neonatal death.	from birth through the first 28 days of life
Secondary	Gestational age of baby	gestational age of the baby on the day of it's birth	measured within the first 24 hours following birth.
Secondary	Baby's birth weight	weight of the baby taken with in the first hours following birth	measured within the first 24 hours following birth
Secondary	Intrauterine growth restriction (IUGR)	a measurement done by ultrasound taken at any time during the pregnancy prior to birth	anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
Secondary	Baby's Head Circumference	a measurement of the baby's head taken within the first hours following birth	measured within the first 24 hours following birth
Secondary	Newborn Mechanical Ventilatory days	measurement of the total number of days the baby requires mechanical ventilatory support	measured from birth to 28 days following birth
Secondary	Newborn Oxygen support days	measurement of the total number of days the baby requires oxygen support (example: nasal cannula, CPAP)	measured from birth to 28 days following birth
Secondary	Newborn Surfactant therapy	measurement of the need for newborn surfactant therapy within the first 28 day following birth	measured within the first 24 hours following birth
Secondary	Newborn Hospital Days	the number of days that newborn remains in the hospital following its birth.	measured within the first 24 hours following birth
Secondary	Pneumothorax	diagnosis of a collapsed lung supported by clinical or radiologic evidence.	measured within the first 24 hours following birth
Secondary	Maternal Infectious Morbidity	diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection.	measured within the first 24 hours following birth
Secondary	time from first dose of study drug to birth	the number of hours/days from the time of the first dose of study drug until birth	measured in days/hours from the time of administration of first study drug until birth.