Trials / Completed
CompletedNCT04831086
To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis
To Optimize Antenatal Management of Women Admitted With Pre Term Labor and Intact Membranes Using Multivariable Prediction Models: Multicenter Randomised Control Trial (OPTIM-PTL)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 247 (actual)
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes
Detailed description
To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection: 1. Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes. 2. It is a cost-effective strategy. 3. It improves neonatal outcome (in premature newborns \<30 weeks), and reduces infectious maternal morbility. 4. It improves neurodevelopmental outcome at 1.2 and 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Steroid Drug | Steroids doses will be optimized in the intervention group according the risk based on predictive models |
| DRUG | Tocolytic Agents | Tocolysis duration will be optimized in the intervention group according the risk based on predictive models |
Timeline
- Start date
- 2021-05-05
- Primary completion
- 2024-10-30
- Completion
- 2024-12-30
- First posted
- 2021-04-05
- Last updated
- 2025-03-12
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04831086. Inclusion in this directory is not an endorsement.