Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
NCT ID: NCT02939742
Last Updated: 2024-01-26
Study Results
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Basic Information
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TERMINATED
PHASE2/PHASE3
33 participants
INTERVENTIONAL
2016-11-30
2023-12-20
Brief Summary
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Detailed Description
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Objectives
1. To evaluate the impact of maternal treatment with a second course of betamethasone on infant length of stay in the NICU.
2. To evaluate the impact of maternal treatment with a second course of betamethasone on the duration of neonatal need for oxygen supplementation.
3. To evaluate the impact of maternal treatment with a second course of betamethasone on neonatal morbidity overall.
Hypotheses The investigators hypothesize that treatment of women with PPROM between 24 and 34 weeks of gestation with a repeat course of antenatal corticosteroids decreases infant length of stay in the NICU and neonatal morbidity.
Aim To describe and compare the neonatal outcomes of PPROM infants exposed to a repeat course of antenatal corticosteroids compared to infants in the same antenatal conditions who are exposed to only one betamethasone course.
Subject Safety and Data Monitoring This study does not place subjects at risk of their safety. This medication is well studied and known to be safe in pregnancy.
Data monitoring will be performed and viewed by study personnel only. The data will be de-identified and a study number will be assigned to each patient. The patient's identity will be secured on a UTMB encrypted laptop device and a hard copy stored in the locked file cabinet in the locked office of the principal investigator.
Procedures to Maintain Confidentiality:
Data will be viewed by study personnel only. The data will then be de-identified and a study number will be assigned to each patient. The patient's identity will then be secured on a UTMB encrypted laptop device and a hard copy stored in the locked file cabinet in the locked office of the principal investigator.
Potential Benefits The potential benefits to subjects participating in the study include possible decreased neonatal morbidity and length of stay in the NICU.
Biostatistics Using data from the University of Texas Medical Branch (UTMB) on women with PPROM between 24 and 34 weeks, who fit the inclusion criteria, and who received the standard one course of betamethasone, the average length of stay in the NICU was 59.3 ± 36.3 days. The gestational age at delivery in this cohort was 26.5 ± 3.2 weeks.
Assuming that a second course of betamethasone reduces the length of stay needed in the NICU by 35%, and for a power of 80% and alpha 0.05, it is anticipated that enrollment of 49 women in each group will be needed, or 98 women total.
At UTMB, there are approximately 400 women per year hospitalized with PPROM. Assuming 50% of eligible women consent, the investigators estimate to finish recruitment for this study in 1-2 years.
Sample Size and Assumptions
1. Frequency of primary outcome in control group (single course of betamethasone): is 59.3 days. The investigators assume a 35% reduction in length of NICU stay using two courses of betamethasone.
2. α = 0.05, two sided
3. β = 0.2
4. Effect size: 35% reduction in primary outcome
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Betamethasone
Women admitted with PPROM who will receive a second course of two betamethasone 12mg intramuscular (IM) injections given 24 hours apart.
Betamethasone
Betamethasone 12mg IM given every 24 hours for two doses
Saline Placebo
Women admitted with PPROM who will receive intramuscular saline placebo, given as two injections 24 hours apart.
Placebo
Sterile 0.9% normal saline solution given IM every 24 hours for two doses
Interventions
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Betamethasone
Betamethasone 12mg IM given every 24 hours for two doses
Placebo
Sterile 0.9% normal saline solution given IM every 24 hours for two doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Preterm premature rupture of membranes, demonstrated clinically by speculum exam
* Cervical dilation visually ≤ 5cm on sterile speculum exam
* Planned delivery at John Sealy Hospital (JSH)
* Gestational age of membrane rupture and initiation of first course of antenatal corticosteroids between 23 5/7 - 32 5/7 weeks
* Planned pregnancy continuation with no indication for delivery for at least 7 days
Exclusion Criteria
* Gestational age \< 23 5/7 weeks or \> 32 5/7 weeks
* Known major congenital abnormalities, aneuploidy, or genetic syndrome
* Intrauterine fetal demise
* Any indication for expedited delivery
* Maternal chorioamnionitis
* Known allergy or adverse reaction to corticosteroids
18 Years
50 Years
FEMALE
Yes
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Benjamin Bush, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Medical Branch in Galveston
Locations
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University of Texas Medical Branch in Galveston
Galveston, Texas, United States
Countries
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References
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Atarod Z, Taghipour M, Roohanizadeh H, Fadavi S, Taghavipour M. Effects of single course and multicourse betamethasone prior to birth in the prognosis of the preterm neonates: A randomized, double-blind placebo-control clinical trial study. J Res Med Sci. 2014 Aug;19(8):715-9.
Brookfield KF, El-Sayed YY, Chao L, Berger V, Naqvi M, Butwick AJ. Antenatal corticosteroids for preterm premature rupture of membranes: single or repeat course? Am J Perinatol. 2015 May;32(6):537-44. doi: 10.1055/s-0034-1396690. Epub 2014 Dec 29.
Elimian A, Verma U, Canterino J, Shah J, Visintainer P, Tejani N. Effectiveness of antenatal steroids in obstetric subgroups. Obstet Gynecol. 1999 Feb;93(2):174-9. doi: 10.1016/s0029-7844(98)00400-1.
Elimian A, Verma U, Visintainer P, Tejani N. Effectiveness of multidose antenatal steroids. Obstet Gynecol. 2000 Jan;95(1):34-6. doi: 10.1016/s0029-7844(99)00471-8.
Gyamfi-Bannerman C, Son M. Preterm premature rupture of membranes and the rate of neonatal sepsis after two courses of antenatal corticosteroids. Obstet Gynecol. 2014 Nov;124(5):999-1003. doi: 10.1097/AOG.0000000000000460.
Mazumder P, Dutta S, Kaur J, Narang A. Single versus multiple courses of antenatal betamethasone and neonatal outcome: a randomized controlled trial. Indian Pediatr. 2008 Aug;45(8):661-7.
National Institutes of Health Consensus Development Panel. Antenatal corticosteroids revisited: repeat courses - National Institutes of Health Consensus Development Conference Statement, August 17-18, 2000. Obstet Gynecol. 2001 Jul;98(1):144-50. doi: 10.1016/s0029-7844(01)01410-7.
Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.
Wijnberger LD, Mostert JM, van Dam KI, Mol BW, Brouwers H, Visser GH. Comparison of single and repeated antenatal corticosteroid therapy to prevent neonatal death and morbidity in the preterm infant. Early Hum Dev. 2002 Apr;67(1-2):29-36. doi: 10.1016/s0378-3782(01)00248-1.
Yang SH, Choi SJ, Roh CR, Kim JH. Multiple courses of antenatal corticosteroid therapy in patients with preterm premature rupture of membranes. J Perinat Med. 2004;32(1):42-8. doi: 10.1515/JPM.2004.007.
Other Identifiers
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15-0280
Identifier Type: -
Identifier Source: org_study_id
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