Single Versus Repeat Betamethasone in Twin Pregnancies

Twin; Complicating Pregnancy Clinical Trial

Official title:

Repeat Versus Single Course of Betamethasone in Twin Pregnancies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04212312
• Other study ID #: 0484-19
• Status: Not yet recruiting
• Start date: February 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: December 2019
• Source: Rambam Health Care Campus
• Contact: Yaniv Zipori, M.D
• Phone: +972 58 7966963
• Email: y_zipori[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2021
• Est. primary completion date: December 1, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Twin; Complicating Pregnancy

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation	The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation	1 year