deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04831086

To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis (OPTIM-PTL)

To Optimize Antenatal Management of Women Admitted With Pre Term Labor and Intact Membranes Using Multivariable Prediction Models: Multicenter Randomised Control Trial (OPTIM-PTL)

Sponsor: Complexo Hospitalario Universitario de A Coruña

Updated 10 times since 2021 Last updated: Mar 11, 2025 Started: May 5, 2021 Primary completion: Oct 30, 2024 Completion: Dec 30, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Amniocentesis Affecting Fetus or Newborn and Intra-amniotic Infection and is currently completed. Complexo Hospitalario Universitario de A Coruña leads this study, which shows 10 recorded versions since 2021 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~May 2021 – ~Jun 2021 · 31 days · monthly snapshotNot Yet Recruiting~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshotRecruiting~Sep 2021 – ~Jun 2022 · 9 months · monthly snapshotRecruiting~Jun 2022 – ~Nov 2023 · 17 months · monthly snapshotRecruiting~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshotRecruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshotUnknown~Oct 2024 – ~Apr 2025 · 6 months · monthly snapshotRecruiting~Apr 2025 – present · 15 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Apr 2025 — Present [monthly]

    Completed PHASE3

    Status: RecruitingCompleted

  2. Oct 2024 — Apr 2025 [monthly]

    Recruiting PHASE3

    Status: UnknownRecruiting

  3. Sep 2024 — Oct 2024 [monthly]

    Unknown PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown StatusUnknown

  5. Jun 2024 — Jul 2024 [monthly]

    Unknown Status PHASE3

    Status: RecruitingUnknown Status

Show 5 earlier versions
  1. Nov 2023 — Jun 2024 [monthly]

    Recruiting PHASE3

  2. Jun 2022 — Nov 2023 [monthly]

    Recruiting PHASE3

  3. Sep 2021 — Jun 2022 [monthly]

    Recruiting PHASE3

  4. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  5. May 2021 — Jun 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Complexo Hospitalario Universitario de A Coruña
  • Consorci Sanitari de Terrassa
  • Fundacion Clinic per a la Recerca Biomédica
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Germans Trias i Pujol Hospital
  • Hospital Clínico Universitario Lozano Blesa
  • Hospital Sant Joan de Deu
  • Hospital Son Llatzer
  • Hospital Universitari Joan XXIII de Tarragona.
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Fe
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta del Mar
  • Hospital Universitario de Torrejón
  • Hospital Vall d'Hebron
  • Parc Taulí Hospital Universitari
  • University Hospital Virgen de las Nieves
Data source: Fundacion Clinic per a la Recerca Biomédica

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

Study Locations