Preterm Labor With Intact Membranes
Conditions
Keywords
Preterm labor
Brief summary
To demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation
Detailed description
Randomised patients would be assigned to receive indomethacin either placebo oral use(50 mg every 6 hours during 5 days) to evaluate the efficacy of indomethacin as complementary treatment to increase the gestational age at delivery in women admitted with preterm labor and intact membranes with high risk of intraamniotic inflammation, defined as a gestational age at admission less than 28.0 weeks or those women from 28-32.0 weeks with a sonographic cervical length less than 15 mm
Interventions
DRUGindomethacin
50 mg / 6 hours during 5 days
DRUGplacebo
50 mg / 6 hours during 5 days
Sponsors
Sara Varea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pregnant women with preterm labor admitted to hospital and treated with tocolysis * pregnant women less than 28.0 and those women from 28.0 to 32.0 with a sonographic cervical length \< 15 mm * single pregnancy * normal amniotic fluid * normal arterial ductus
Exclusion criteria
* Age below 18 years * previous use of indomethacin in the index pregnancy * chorioamnionitis, preterm prelabour rupture of membranes or those fetal or maternal pathologies which could be responsible of an iatrogenic preterm delivery. * oligohydramnios * allergy to NSAID * previous history of gastrointestinal bleeding * use of NSAID contraindicated * not adherence to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at delivery | before than 42 weeks of gestation | number of weeks and days at delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 1 year (end of study) | adverse events will be registered |
| Latency from admission to delivery | between initial admission and delivery (before 42 weeks of gestation) | Latency from admission to delivery will be calculated |
| IL-6 levels in amniotic fluid and umbilical cord blood | delivery (maximum 42 weeks of gestational age) | the investigators will determine the level of IL-6 in different samples |
| proportion of patients with spontaneous preterm delivery before 34 weeks of gestation | at the end of study (maximum 1 year) | the participants will be followed until delivery. The proportion of patiens with spontaneous preterm delivery before week 34 will be available at the end of the study, once the last patient delivers. |
| Neonatal morbidity | at the end of the study (1 year) | neonatal morbidity will be registered: * admission to Neonatal Intensive Care Unit (NICU) * number of days of NICU admission * respiratory distress syndrome * intraventricular haemorrage * early onset neonatal sepsis * necrotizing enterocolitis * late neonatal sepsis * neonatal death. |
| Neonatal death | at the end of the study (1 year) | Neonatal deaths will be registered |
| Number of emergency visits | between initial admission and delivery (before 42 weeks of gestation) | Number of visits to emergency area will be registered |
Countries
Spain
Outcome results
None listed