Single Versus Repeat Betamethasone in Twin Pregnancies

December 24, 2019 updated by: Yaniv Zipori MD, Rambam Health Care Campus

Repeat Versus Single Course of Betamethasone in Twin Pregnancies

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women carrying twins, and who received antenatal Betamethasone between 24-34 weeks' gestation for threatened preterm labor.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Yaniv Zipori, M.D, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

November 2, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 24, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0484-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided yet, maybe in the future or part of a meta-analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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