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NCT02511574: PAP-C
Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth
Phase 4 trial testing natural progesterone in Preterm Labor in 203 participants. Completed in 30 August 2023.
10 December 2022
Quick facts
| Lead sponsor | University of Sao Paulo |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 203 |
| Start date | 3 August 2015 |
| Primary completion | 10 December 2022 |
| Estimated completion | 30 August 2023 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- natural progesterone — full drug profile →
- cervical pessary
Conditions studied
- Preterm Labor — all drugs for Preterm Labor →
- Premature Birth — all drugs for Premature Birth →
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):
-
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 -
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 -
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:
- PubMed search for NCT02511574
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Preterm Labor
Currently open trials in the same condition.
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- NCT07263490 — PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients) · recruiting
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- NCT05698966 — Low Dose Antenatal Corticosteroids for Late Preterm Delivery · NA · recruiting
- NCT06074601 — MIRACLE of LIFE Study · active not recruiting
Other University of Sao Paulo trials
Trials by the same sponsor.
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- NCT07445178 — Piecemeal Resection and Advanced Histology Independently Predict Local Recurrence After Colorectal Snare-based Endoscopi · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02511574 (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 University of Sao Paulo
- Last refreshed: 19 March 2026
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.
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