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Single Versus Repeat Betamethasone in Twin Pregnancies

R

Rambam Health Care Campus

Status

Unknown

Conditions

Twin; Complicating Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT04212312
0484-19

Details and patient eligibility

About

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 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.

Enrollment

2,000 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Single course of Betamethasone
Description:
Women with twin pregnancy who received 1 course of betamethasone between 24 - 34 weeks' gestation.
Repeat course of Betamethasone
Description:
Women with twin pregnancy who received 2 courses (Repeat course) of betamethasone between 24 - 34 weeks' gestation.

Trial contacts and locations

1

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Central trial contact

Yaniv Zipori, M.D

Data sourced from clinicaltrials.gov

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