Clincosm LogoSign in Get a demo

Single Versus Repeat Betamethasone in Twin Pregnancies

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Unknown status
CT.gov ID
NCT04212312
Collaborator
(none)
2,000
Enrollment
1
Location
11
Anticipated Duration (Months)
181.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Repeat Versus Single Course of Betamethasone in Twin Pregnancies
    Anticipated Study Start Date :
    Feb 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Jan 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam health care campus Haifa Israel

    Sponsors and Collaborators

    • Rambam Health Care Campus

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yaniv Zipori MD, Principal Investigator, Rambam Health Care Campus
    ClinicalTrials.gov Identifier:
    NCT04212312
    Other Study ID Numbers:
    • 0484-19
    First Posted:
    Dec 26, 2019
    Last Update Posted:
    Dec 26, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yaniv Zipori MD, Principal Investigator, Rambam Health Care Campus
    Betamethasone
    Twin pregnancy
    Repeat course
    Single course
    Additional relevant MeSH terms:
    Pregnancy Complications

    Study Results

    No Results Posted as of Dec 26, 2019