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

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ClinicalTrials.gov Identifier: NCT02939742
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
PPROM Respiratory Distress Syndrome in Premature Infants Drug: Betamethasone Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?
Study Start Date : November 2016
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023


Arm Intervention/treatment
Experimental: Betamethasone
Women admitted with PPROM who will receive a second course of two betamethasone 12mg intramuscular (IM) injections given 24 hours apart.
Drug: Betamethasone
Betamethasone 12mg IM given every 24 hours for two doses
Other Name: Celestone

Placebo Comparator: Saline Placebo
Women admitted with PPROM who will receive intramuscular saline placebo, given as two injections 24 hours apart.
Drug: Placebo
Sterile 0.9% normal saline solution given IM every 24 hours for two doses
Other Name: Saline placebo




Primary Outcome Measures :
  1. Length of stay in the neonatal intensive care unit (NICU) [ Time Frame: daily from birth of infant up to one year ]
    expressed in days


Secondary Outcome Measures :
  1. Composite neonatal morbidity [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]
    defined as ≥ 1 of the following: RDS (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe IVH (grades III or IV), periventricular leukomalacia, blood culture-proven sepsis, necrotizing enterocolitis, or perinatal death (stillbirth or death before neonatal hospital discharge)

  2. Duration of oxygen and ventilatory support [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]
    Amount of time in days from birth that the infant requires supplemental oxygen of any form, including nasal cannula, positive airway pressure, or ventilatory support

  3. Development of Respiratory Distress Syndrome (RDS) [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]
    Will be quantified as either present or absent. RDS defined as: compatible symptoms with radiographic evidence of hyaline membrane disease or respiratory insufficiency of prematurity requiring ventilatory support for ≥ 24 hrs

  4. Grade III or IV intraventricular hemorrhage (IVH) [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]
    Will be quantified as either present or absent. Grade III IVH defined as ventricles enlarged by accumulating blood. Grade IV IVH defined as bleeding extending into brain matter around the ventricles.

  5. Neonatal Sepsis [ Time Frame: daily up to 72 hours of life ]
    confirmed by culture in the first 72 hours of life

  6. Necrotizing enterocolitis (NEC) stage 2 or 3 [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]
    Will be quantified as either present or absent. Stage 2 NEC will be defined as mild to moderate systemic illness, absent bowel sounds, abdominal tenderness, pneumatosis intestinalis or portal venous gas, metabolic acidosis, decreased platelets. Stage 3 NEC will be defined as severely ill, marked distention, signs of peritonitis, hypotension, metabolic & respiratory acidosis, disseminated intravascular coagulopathy, pneumoperitoneum if bowel perforation present.

  7. Perinatal death [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]
    defined as stillbirth or death before neonatal discharge


Other Outcome Measures:
  1. Labor latency [ Time Frame: time from admission to delivery up to one year, or through study completion ]
    time from diagnosis of PPROM from admission until delivery of neonate or until completion of the study

  2. Infectious morbidities [ Time Frame: time from admission until maternal discharge from the hospital and up until 6 weeks postpartum, or through study completion ]
    Chorioamnionitis will be defined as at least one temperature elevation above 38°C combined with at least two of the following signs: maternal or fetal tachycardia, uterine tenderness, foul smelling vaginal discharge, white blood count > 18,000. Postpartum endometritis will be defined as postpartum temperature elevation above 38°C without other localizing sources of infection and with either uterine tenderness or foul-smelling lochia.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939742


Contacts
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Contact: Mauricio La Rosa De Los Rios, MD 409-772-1571 malarosa@UTMB.EDU
Contact: Maggie j Kuhlmann-Capek, MD 409-772-1571 makuhlma@UTMB.EDU

Locations
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United States, Texas
University of Texas Medical Branch in Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Mauricio La Rosa De Los Rios, MD    409-772-1571    malarosa@UTMB.EDU   
Contact: Ester Godbold, RN    409-772-0991    esgodbol@utmb.edu   
Principal Investigator: Maged M Costantine, MD         
Sub-Investigator: Mauricio La Rosa De Los Rios, MD         
Sub-Investigator: Gayle L Olson-Koutrouvelis, MD         
Sub-Investigator: Maggie J Kuhlmann-Capek, MD         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Maged M Costantine, MD University of Texas Medical Branch in Galveston

Publications:

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02939742     History of Changes
Other Study ID Numbers: 15-0280
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Medical Branch, Galveston:
preterm premature rupture of membranes
complications of prematurity
neonatal morbidity
respiratory distress syndrome
antenatal corticosteroids
betamethasone
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents