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NCT03788473: PERIOEM
"Periodontal Disease as a Possible Risk Factor for Complications During Pregnancy and Childbirth
trial in Periodontitis During Pregnancy in 350 participants. Status unknown.
26 July 2019
Quick facts
| Lead sponsor | Universidad de Granada |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 350 |
| Start date | 15 March 2018 |
| Primary completion | 26 July 2019 |
| Estimated completion | 26 November 2021 |
| Sites | 1 location across Spain |
Conditions studied
- Periodontitis During Pregnancy — all drugs for Periodontitis During Pregnancy →
Sponsor
Universidad de Granada — full company profile →
Who can join
Adults 18 to 50, female only, with Periodontitis During Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pregnancy is a physiological state that is part of the reproductive life of women, establishing their fertile age between 15 and 45 years mainly. This stage will not only mark the birth of the baby but also cause various changes both immunological and physiological, to accommodate the growing fetus. Maternal periodontitis has direct and indirect potential to influence the health of the fetus-maternal unit. According to the literature reviewed, the first evidence that oral bacteria influenced pregnancy outcomes was reported by Collins et al. The injection of P. gingivalis into pregnant hamsters caused intrauterine growth retardation and smaller fetuses, together with an increase in the levels of proinflammatory mediators (IL-1b and PGE2) in the amniotic fluid. Two hypotheses have been pointed out regarding the link between oral health and the adverse outcome of pregnancy. The first states that periodontal disease causes abnormal systemic immune changes, leading to complications in pregnancy. While the second hypothesis suggests that oral bacteria directly colonize the placenta, causing localized inflammatory responses, resulting in prematurity and other adverse outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03788473
- Europe PMC full search
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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 NCT03788473 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad de Granada
- Last refreshed: 27 December 2018
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/NCT03788473.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing