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NCT05857059
Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration
NA trial testing Misoprostol 25 mcg in Labor, Induced in 228 participants. Status unknown.
31 May 2024
Quick facts
| Lead sponsor | Unidade Local de Saúde de Coimbra, EPE |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 228 |
| Start date | 15 October 2019 |
| Primary completion | 31 May 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across Portugal |
Drugs / interventions tested
- Misoprostol 25 mcg — full drug profile →
- Misoprostol 50 mcg — full drug profile →
Conditions studied
- Labor, Induced — all drugs for Labor, Induced →
- Obesity — all drugs for Obesity →
- Pregnancy — all drugs for Pregnancy →
- Cesarean Section — all drugs for Cesarean Section →
Sponsor
Unidade Local de Saúde de Coimbra, EPE — full company profile →
Who can join
Adults 15 to 55, female only, with Labor, Induced or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In recent decades, obesity has become a prevalent issue in Portugal, with 38.6% and 13.8% of the population being overweight or obese, respectively. Obese pregnant women have a higher rate of obstetric complications, including hypertensive complications, gestational diabetes and fetal macrosomia, leading to increased induction of labor (IOL) and cesarean section (CS) rates. To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL, a randomized controlled trial with a sample size of 114 cases in each group was calculated to detect a 15% difference in CS rate. The primary objective is to determine the effect of increasing oral misoprostol dose, with secondary goals being to compare successful IOL rates and their relationship with oral misoprostol dose, as well as to evaluate tolerability and side effects in relation to different doses of oral misoprostol.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05857059
- 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
- NCT03744364 — Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor · Phase 4 · completed
Other recruiting trials for Labor, Induced
Currently open trials in the same condition.
- NCT07237880 — Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-ball · NA · recruiting
- NCT06591247 — Membrane Stripping for Cervical Ripening · NA · recruiting
- NCT07288021 — Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE) · Phase 4 · recruiting
- NCT05177510 — Mifepristone Outpatient Labour Induction · Phase 2 · recruiting
Other Unidade Local de Saúde de Coimbra, EPE trials
Trials by the same sponsor.
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- NCT06422832 — Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial · NA · not yet recruiting
- NCT06882850 — Immunomodulation During Pregnancy · 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 NCT05857059 (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 Unidade Local de Saúde de Coimbra, EPE
- Last refreshed: 24 October 2023
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/NCT05857059.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing