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NCT02337881
Combined Nifedipine and Sildenafil Citrate Versus Nifedipine Alone in Acute Tocolysis of Preterm Labor: A Randomized Clinical Trial
Phase 1 trial testing nifedipen in Labor Preterm Requiring Hospitalization in 227 participants. Status unknown.
1 October 2016
Quick facts
| Lead sponsor | Al Hayat National Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 227 |
| Start date | 1 January 2015 |
| Primary completion | 1 October 2016 |
| Estimated completion | 1 October 2016 |
| Sites | 2 locations across Egypt, Saudi Arabia |
Drugs / interventions tested
- nifedipen — full drug profile →
- Sildenafil (sildenafil) — full drug profile →
Conditions studied
- Labor Preterm Requiring Hospitalization — all drugs for Labor Preterm Requiring Hospitalization →
Sponsor
Al Hayat National Hospital
Who can join
Eligibility, female only, with Labor Preterm Requiring Hospitalization. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
the proportion of women remaining undelivered during the whole period of hospitalization. Treatment failure is considered in participants who delivered during this period, or those who need repeated treatment course.
Time frame: 9 months
Sponsor's own description
The aim of this study is to assess whether or not the emergency tocolytic effect of combined nifedipine and sildenafil citrate will have a superior effect over nifedipine alone in terms of inhibiting eminent preterm labor and improving perinatal outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT02337881
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Related trials
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 NCT02337881 (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 Al Hayat National Hospital
- Last refreshed: 21 June 2016
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/NCT02337881.
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