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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Premature Birth

Intervention / Treatment
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* Drug: Betamethasone - ACTIVE
* Other: Normal Saline - PLACEBO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Betamethasone - ACTIVE<br>Booster Course of Antenatal Steroids consists of Betamethasone [12 mg intramuscular injection, 24 hours apart X 2 doses] or if unavailable may give Dexamethasone [6 mg intramuscularly 12 hours apart x 4 doses] | Drug: Betamethasone - ACTIVE<br>* antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.<br>* Other names: dexamethasone;|
| Placebo Comparator: normal saline - PLACEBO<br>Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm. | Other: Normal Saline - PLACEBO<br>* normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age of baby | gestational age of the baby on the day of it's birth | measured within the first 24 hours following birth. | 
| Baby's birth weight | weight of the baby taken with in the first hours following birth | measured within the first 24 hours following birth | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Newborn Hospital Days | the number of days that newborn remains in the hospital following its birth. | measured within the first 24 hours following birth | 
| Pneumothorax | diagnosis of a collapsed lung supported by clinical or radiologic evidence. | measured within the first 24 hours following birth | 
| Maternal Infectious Morbidity | diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection. | measured within the first 24 hours following birth | 
| 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. |