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Clinical Trials/NCT04212312
NCT04212312
Unknown
Not Applicable

Repeat Versus Single Course of Betamethasone in Twin Pregnancies

Rambam Health Care Campus1 site in 1 country2,000 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Twin; Complicating Pregnancy
Sponsor
Rambam Health Care Campus
Enrollment
2000
Locations
1
Primary Endpoint
The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
January 1, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yaniv Zipori MD

Principal Investigator

Rambam Health Care Campus

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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