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NCT03744364: MADUTER
Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor
Phase 4 trial testing Misoprostol 25 mcg in Induced Labor in 198 participants. Completed in 1 November 2017.
20 October 2017
Quick facts
| Lead sponsor | Hospital Miguel Servet |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 198 |
| Start date | 1 June 2014 |
| Primary completion | 20 October 2017 |
| Estimated completion | 1 November 2017 |
Drugs / interventions tested
- Misoprostol 25 mcg — full drug profile →
- Dinoprostone 10mg — full drug profile →
Conditions studied
- Induced Labor — all drugs for Induced Labor →
- Cervical Ripening — all drugs for Cervical Ripening →
- Obstetric Labor — all drugs for Obstetric Labor →
- Pregnancy — all drugs for Pregnancy →
Sponsor
Hospital Miguel Servet
Who can join
Adults 18 to 50, female only, with Induced Labor or Cervical Ripening. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Purpose: To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies. Methods: The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03744364
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Misoprostol 25 mcg
Trials testing the same drug.
- NCT07109258 — Effect of Dexamethasone on Labour Induction in Term Pregnancies · EARLY_PHASE1 · recruiting
- NCT05857059 — Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration · NA · unknown
Other Hospital Miguel Servet trials
Trials by the same sponsor.
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- NCT06656065 — IMR-Heart Trasplant Study · recruiting
- NCT05317754 — Effectiveness of Four Deconstructive Meditative Practices on Well-being and Self-deconstruction · NA · active not recruiting
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 NCT03744364 (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 Hospital Miguel Servet
- Last refreshed: 16 November 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/NCT03744364.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing