Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?

NCT02939742 | Terminated Phase 2

• 1 other identifier: 15-0280
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition.

Conditions

PPROM; Respiratory Distress Syndrome in Premature Infants

Keywords

preterm premature rupture of membranes; complications of prematurity; neonatal morbidity; respiratory distress syndrome; antenatal corticosteroids; betamethasone

Outcome Measures

Primary Outcomes (1)

• Length of stay in the neonatal intensive care unit (NICU)

  expressed in days

  daily from birth of infant up to one year

Secondary Outcomes (7)

• Composite neonatal morbidity

  assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first

• Duration of oxygen and ventilatory support

  assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first

• Development of Respiratory Distress Syndrome (RDS)

  assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first

• Grade III or IV intraventricular hemorrhage (IVH)

  assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first

• Neonatal Sepsis

  daily up to 72 hours of life

Other Outcomes (2)

• Labor latency

  time from admission to delivery up to one year, or through study completion

• Infectious morbidities

  time from admission until maternal discharge from the hospital and up until 6 weeks postpartum, or through study completion

Study Arms (2)

Betamethasone

EXPERIMENTAL

Women admitted with PPROM who will receive a second course of two betamethasone 12mg intramuscular (IM) injections given 24 hours apart.

Drug: Betamethasone

Saline Placebo

PLACEBO COMPARATOR

Women admitted with PPROM who will receive intramuscular saline placebo, given as two injections 24 hours apart.

Drug: Placebo

Interventions

Betamethasone DRUG

Betamethasone 12mg IM given every 24 hours for two doses

Also known as: Celestone

Betamethasone

Placebo DRUG

Sterile 0.9% normal saline solution given IM every 24 hours for two doses

Also known as: Saline placebo

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Maternal age ≥ 18 years
• 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

You may not qualify if:

• Maternal age \> 50 years
• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch in Galveston

Galveston, Texas, 77555, United States

Location

Related Publications (10)

• 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.

  PMID: 25422655 BACKGROUND

• 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.

  PMID: 25545441 BACKGROUND

• 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.

  PMID: 9932550 BACKGROUND

• 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.

  PMID: 10636498 BACKGROUND

• 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.

  PMID: 25437730 BACKGROUND

• 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.

  PMID: 18723909 BACKGROUND

• 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.

  PMID: 11430973 BACKGROUND

• Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.

  PMID: 24084566 BACKGROUND

• 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.

  PMID: 11893433 BACKGROUND

• 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.

  PMID: 15008385 BACKGROUND

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Respiratory Distress Syndrome In Premature Infants; Respiratory Distress Syndrome

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Benjamin Bush, MD

  University of Texas Medical Branch in Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 20, 2016
• Study Start: November 1, 2016
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)