deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT02133573

Randomized Trial of Maternal Progesterone Therapy

Randomized Trial of Maternal Progesterone Therapy to Improve Neurodevelopmental Outcomes in Infants With Congenital Heart Disease

Sponsor: Children's Hospital of Philadelphia

Conditions Brain Development Cardiac Surgery Congenital Heart Disease Fetal Neuroprotection Neurodevelopmental Disability Periventricular Leucomalacia
Interventions Progesterone Vaginal lubricant
Updated 18 times since 2017 Last updated: Aug 8, 2023 Started: Jul 31, 2014 Primary completion: Nov 30, 2021 Completion: Nov 30, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Brain Development and Cardiac Surgery and is currently completed. Children's Hospital of Philadelphia leads this study, which shows 18 recorded versions since 2014 — indicating substantial longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Mar 2019 · 6 months · monthly snapshot~Mar 2019 – ~Sep 2019 · 6 months · monthly snapshot~Sep 2019 – ~Apr 2020 · 7 months · monthly snapshot~Apr 2020 – ~Oct 2020 · 6 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Oct 2021 · 7 months · monthly snapshot~Oct 2021 – ~Feb 2022 · 4 months · monthly snapshot~Feb 2022 – ~Nov 2022 · 9 months · monthly snapshot~Nov 2022 – ~Mar 2023 · 4 months · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Sep 2023 · 5 months · monthly snapshot~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Sep 2023 — Jul 2024 [monthly]

    Completed PHASE2

  4. Apr 2023 — Sep 2023 [monthly]

    Completed PHASE2

  5. Mar 2023 — Apr 2023 [monthly]

    Completed PHASE2

▶ Show 13 earlier versions

  1. Nov 2022 — Mar 2023 [monthly]

    Completed PHASE2

  2. Feb 2022 — Nov 2022 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  3. Oct 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE2

  4. Mar 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE2

  5. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2

  6. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  7. Apr 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  8. Sep 2019 — Apr 2020 [monthly]

    Recruiting PHASE2

  9. Mar 2019 — Sep 2019 [monthly]

    Recruiting PHASE2

  10. Sep 2018 — Mar 2019 [monthly]

    Recruiting PHASE2

  11. Jun 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  12. Feb 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

  13. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Jul 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Children's Hospital of Philadelphia
Data source: Children's Hospital of Philadelphia

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations