Last reviewed · How we verify

NCT02511574: PAP-C

Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth

Completed Phase 4 Last updated 19 March 2026
What this trial tests

Phase 4 trial testing natural progesterone in Preterm Labor in 203 participants. Completed in 30 August 2023.

Timeline
3 August 2015
Primary endpoint
10 December 2022
30 August 2023

Quick facts

Lead sponsorUniversity of Sao Paulo
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment203
Start date3 August 2015
Primary completion10 December 2022
Estimated completion30 August 2023
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo

Who can join

Eligibility, female only, with Preterm Labor or Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to compare the effectiveness between the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervical length of 25 mm or less evaluated by transvaginal ultrasonography.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cervical pessary for preventing preterm birth in singleton pregnancies.
    Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. · · 2022 · cited 10× · PMID 36453699 · DOI 10.1002/14651858.cd014508
  2. Women's Obstetric History and Midtrimester Cervical Length Measurements by 2D/3D and Doppler Ultrasound.
    Marinelli JVC, Filho AGA, de Barros MF, Rodrigues AS, et al · · 2020 · cited 3× · PMID 32575132 · DOI 10.1055/s-0040-1713010
  3. Vaginal Microbiota in Short Cervix Pregnancy: Secondary Analysis of Pessary vs. Progesterone Trial.
    Amorim Filho AG, Martins RCR, Franco LAM, Marinelli JVC, et al · · 2025 · PMID 41149072 · DOI 10.3390/diseases13100338

Verify or expand the search:

Other recruiting trials for Preterm Labor

Currently open trials in the same condition.

Other University of Sao Paulo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02511574.

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