Single Versus Repeat Betamethasone in Twin Pregnancies

Overview

Thus far no robust data exist as to the effect of repeted course of antenatal corticosteroids in twin pregnancies. The investigators hypothesized that repeat course of betamethasone would further reduce neonatal morbidity in twins born before 34 weeks' gestation when compared with single dose.

Full Title of Study: “Repeat Versus Single Course of Betamethasone in Twin Pregnancies”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 1, 2020

Detailed Description

Observational data suggest benefits in multiple gestations exposed to antenatal corticosteroids, although these studies have not consistently reported a statistical benefit or the benefits achieved in singletons. Nevertheless, based on the improved outcomes reported in singleton gestations, one course of antenatal corticosteroids is administered to all patients who are between 24 weeks and 34 weeks of gestation and at risk of delivery within 7 days, irrespective of the fetal number. Moreover, "a repeat course" of antenatal corticosteroids should also be considered in women who are less than 34 weeks of gestation who have an imminent risk of preterm delivery within the next 7 days, and whose prior course of antenatal corticosteroids was administered more than 14 days previously, again, irrespective of the fetal number.

The objective of the current study is to evaluate fetal outcomes in twin pregnancies following repeat betamethasone administration during pregnancy.

Arms, Groups and Cohorts

  • Single course of Betamethasone
    • Women with twin pregnancy who received 1 course of betamethasone between 24 – 34 weeks’ gestation.
  • Repeat course of Betamethasone
    • Women with twin pregnancy who received 2 courses (Repeat course) of betamethasone between 24 – 34 weeks’ gestation.

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks’ gestation
    • Time Frame: 1 year
    • The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks’ gestation

Participating in This Clinical Trial

Inclusion Criteria

  • Study group – women who received 2 courses of betamethasone between 24 – 34 weeks' gestation.
  • Control comparison group – women who received 1 course of betamethasone between 24 34 weeks' gestation.

Exclusion Criteria

  • singletone pregnancies
  • higher order multiple pregnancies (triplets and above)
  • known major congenital anomaly

Gender Eligibility: Female

Pregnant women with twin pregnancies, and who received Betamethsone during the course of their pregnancy for threatened preterm labor.

Minimum Age: N/A

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yaniv Zipori MD, Principal Investigator – Rambam Health Care Campus
  • Overall Official(s)
    • Yaniv Zipori, M.D, Principal Investigator, Rambam Health Care Campus
  • Overall Contact(s)
    • Yaniv Zipori, M.D, +972 58 7966963, y_zipori@rambam.health.gov.il

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