NCT04212312

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

November 2, 2019

Last Update Submit

December 24, 2019

Conditions

Twin; Complicating Pregnancy

Keywords

BetamethasoneTwin pregnancyRepeat courseSingle course

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women with twin pregnancies, and who received Betamethsone during the course of their pregnancy for threatened preterm labor.
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • singletone pregnancies
  • higher order multiple pregnancies (triplets and above)
  • known major congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Yaniv Zipori, M.D

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaniv Zipori, M.D

CONTACT

+972 58 7966963y_zipori@rambam.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2019

First Posted

December 26, 2019

Study Start

February 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations

IL(1)