Single Versus Repeat Betamethasone in Twin Pregnancies

• Conditions: Twin; Complicating Pregnancy

• Registration Number: NCT04212312
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2019-11-02
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-24
• Last Update Submitted: 2019-12-24
• Study First Posted: 2019-12-26
• Last Update Posted: 2019-12-26
• Study Start: 2020-02-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation	1 year	The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel