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Single Versus Repeat Betamethasone in Twin Pregnancies

NCT ID: NCT04212312

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Twin; Complicating Pregnancy

Keywords

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Betamethasone Twin pregnancy Repeat course Single course

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single course of Betamethasone

Women with twin pregnancy who received 1 course of betamethasone between 24 - 34 weeks' gestation.

No interventions assigned to this group

Repeat course of Betamethasone

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Yaniv Zipori MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaniv Zipori, M.D

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam health care campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yaniv Zipori, M.D

Role: CONTACT

Phone: +972 58 7966963

Email: [email protected]

Other Identifiers

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0484-19

Identifier Type: -

Identifier Source: org_study_id