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Completed

NCT Number: NCT02469519

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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of South Alabama Medical Center, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betamethasone - ACTIVE

Drug

antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.

Other names: antenatal corticosteroid, dexamethasone

Normal Saline - PLACEBO

Other

normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses

Other names: NS

Primary outcomes

  1. Composite Neonatal Morbidity

    Time frame: from birth through the first 28 days of life

    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.

Secondary outcomes

  1. Gestational age of baby

    Time frame: measured within the first 24 hours following birth.

    gestational age of the baby on the day of it's birth

  2. Baby's birth weight

    Time frame: measured within the first 24 hours following birth

    weight of the baby taken with in the first hours following birth

  3. Intrauterine growth restriction (IUGR)

    Time frame: anytime during the pregnancy prior to birth (~ 9 months of pregnancy)

    a measurement done by ultrasound taken at any time during the pregnancy prior to birth

  4. Baby's Head Circumference

    Time frame: measured within the first 24 hours following birth

    a measurement of the baby's head taken within the first hours following birth

  5. Newborn Mechanical Ventilatory days

    Time frame: measured from birth to 28 days following birth

    measurement of the total number of days the baby requires mechanical ventilatory support

  6. Newborn Oxygen support days

    Time frame: measured from birth to 28 days following birth

    measurement of the total number of days the baby requires oxygen support (example: nasal cannula, CPAP)

  7. Newborn Surfactant therapy

    Time frame: measured within the first 24 hours following birth

    measurement of the need for newborn surfactant therapy within the first 28 day following birth

  8. Newborn Hospital Days

    Time frame: measured within the first 24 hours following birth

    the number of days that newborn remains in the hospital following its birth.

  9. Pneumothorax

    Time frame: measured within the first 24 hours following birth

    diagnosis of a collapsed lung supported by clinical or radiologic evidence.

  10. Maternal Infectious Morbidity

    Time frame: measured within the first 24 hours following birth

    diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection.

  11. time from first dose of study drug to birth

    Time frame: measured in days/hours from the time of administration of first study drug until birth.

    the number of hours/days from the time of the first dose of study drug until birth

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Registry information

Official study 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

Acronym: ACSinPROM

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2015
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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