NCT04831086 (OPTIM-PTL) is a Phase 3 clinical trial of Steroid Drug in Preterm Birth, sponsored by Fundacion Clinic per a la Recerca Biomédica.

Who is sponsoring NCT04831086?

NCT04831086 is sponsored by Fundacion Clinic per a la Recerca Biomédica.

What drugs are being tested in NCT04831086?

Interventions in NCT04831086: Steroid Drug, Tocolytic Agents.

What condition does NCT04831086 study?

NCT04831086 studies Preterm Birth, Preterm Labor, Intra-amniotic Infection, Amniocentesis Affecting Fetus or Newborn.

Is NCT04831086 still recruiting?

NCT04831086 is currently completed. Last updated 12 March 2025.

Last reviewed 2025-03-12 · How we verify

NCT04831086: OPTIM-PTL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis

Completed Phase 3 Last updated 12 March 2025

What this trial tests

Phase 3 trial testing Steroid Drug in Preterm Birth in 247 participants. Completed in 30 December 2024.

Timeline

5 May 2021

Primary endpoint
30 October 2024

30 December 2024

Quick facts

Lead sponsor	Fundacion Clinic per a la Recerca Biomédica
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	247
Start date	5 May 2021
Primary completion	30 October 2024
Estimated completion	30 December 2024
Sites	1 location across Spain

Drugs / interventions tested

Steroid Drug — full drug profile →
Tocolytic Agents — full drug profile →

Conditions studied

Preterm Birth — all drugs for Preterm Birth →
Preterm Labor — all drugs for Preterm Labor →
Intra-amniotic Infection — all drugs for Intra-amniotic Infection →
Amniocentesis Affecting Fetus or Newborn — all drugs for Amniocentesis Affecting Fetus or Newborn →

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Who can join

18 and older, female only, with Preterm Birth or Preterm Labor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study).
Cobo T, Aldecoa V, Bartha JL, Bugatto F, et al · · 2021 · cited 6× · PMID 34588268 · DOI 10.1136/bmjopen-2021-054711

Verify or expand the search:

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Other recruiting trials for Preterm Birth

Currently open trials in the same condition.

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Other Fundacion Clinic per a la Recerca Biomédica trials

Trials by the same sponsor.

NCT07454096 — Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study · Phase 4 · not yet recruiting
NCT07412873 — Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer · Phase 4 · not yet recruiting
NCT07163403 — First in Human Pilot Study to Assess the Safety and Efficacy of Dendritic Cells Loaded With Frameshift Derived Neopeptid · Phase 1 · recruiting
NCT07105384 — Quantification Tools for a Novel Tau PET Marker in a Rare Neurological Disease: 18F-PI-2620 in Progressive Supranuclear · Phase 2 · active not recruiting
NCT06896617 — Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET) · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04831086 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fundacion Clinic per a la Recerca Biomédica
Last refreshed: 12 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04831086.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing