NCT01031017 is a Phase 4 clinical trial of progesterone in Preterm Delivery, sponsored by University of Sao Paulo.

Who is sponsoring NCT01031017?

NCT01031017 is sponsored by University of Sao Paulo.

What drugs are being tested in NCT01031017?

Interventions in NCT01031017: progesterone, placebo.

What condition does NCT01031017 study?

NCT01031017 studies Preterm Delivery.

Is NCT01031017 still recruiting?

NCT01031017 is currently completed. Last updated 3 December 2014.

Last reviewed 2014-12-03 · How we verify

NCT01031017

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

Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies: A Randomized, Double-Blind, Placebo-Controlled Trial

Completed Phase 4 Last updated 3 December 2014

What this trial tests

Phase 4 trial testing progesterone in Preterm Delivery in 390 participants. Completed in 1 June 2014.

Timeline

1 June 2007

Primary endpoint
1 May 2014

1 June 2014

Quick facts

Lead sponsor	University of Sao Paulo
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	390
Start date	1 June 2007
Primary completion	1 May 2014
Estimated completion	1 June 2014
Sites	1 location across Brazil

Drugs / interventions tested

progesterone (Progesterone plus HCG) — full drug profile →
placebo

Conditions studied

Preterm Delivery — all drugs for Preterm Delivery →

Sponsor

University of Sao Paulo

Who can join

Adults 15 to 50, female only, with Preterm Delivery. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

gestational age at delivery
Time frame: once at the end of study

Sponsor's own description

Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. The aim of this study is to investigate the effect of prophylactic administration of natural progesterone in twin pregnancies on the rate of preterm births.

Publications & conference data

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

Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in twin gestations: a systematic review and meta-analysis.
Conde-Agudelo A, Romero R, Rehal A, Brizot ML, et al · · 2023 · cited 28× · PMID 37196896 · DOI 10.1016/j.ajog.2023.05.010
Prenatal administration of progestogens for preventing spontaneous preterm birth in women with a multiple pregnancy.
Dodd JM, Grivell RM, OBrien CM, Dowswell T, et al · · 2017 · cited 25× · PMID 29086920 · DOI 10.1002/14651858.cd012024.pub2
Prenatal administration of progestogens for preventing spontaneous preterm birth in women with a multiple pregnancy.
Dodd JM, Grivell RM, OBrien CM, Dowswell T, et al · · 2019 · cited 14× · PMID 31745984 · DOI 10.1002/14651858.cd012024.pub3

Verify or expand the search:

Other trials of progesterone

Trials testing the same drug.

NCT04537078 — Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders · Phase 3 · completed
NCT04046185 — Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer · EARLY_PHASE1 · unknown
NCT03202836 — Vaginal Progesterone Supplementation in the Management of Preterm Labor · NA · completed
NCT03317548 — A Comparison of Clinical Outcomes of Warmed Embryo Vitrified at 2PN Stage and Fresh Embryo Transfers · unknown
NCT03120715 — Pregnancy Outcome of Women Using Low Molecular Weight Heparin Before Frozen-thawed Embryo Transfer · Phase 4 · unknown

Other recruiting trials for Preterm Delivery

Currently open trials in the same condition.

NCT06980025 — Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial · Phase 3 · recruiting

Other University of Sao Paulo trials

Trials by the same sponsor.

NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
NCT07522554 — Lavender and Lemongrass Aromatherapy for Pain and Anxiety in Labor: A Randomized Trial · NA · active not recruiting
NCT07479940 — Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters · NA · active not recruiting
NCT07445178 — Piecemeal Resection and Advanced Histology Independently Predict Local Recurrence After Colorectal Snare-based Endoscopi · completed
NCT07170007 — Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma · NA · 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 NCT01031017 (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: 3 December 2014

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/NCT01031017.

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