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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| indomethacin | Experimental | 50 mg/ 6 hours of indomethacin oral use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indomethacin | Drug | 50 mg / 6 hours during 5 days |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at delivery | number of weeks and days at delivery | before than 42 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with spontaneous preterm delivery before 34 weeks of gestation | 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. | at the end of study (maximum 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona- Maternity | Barcelona | Barcelona | 08028 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35947046 | Derived | Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2. |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
50 mg / 6 hours during 5 days |
|
| Incidence of adverse events |
adverse events will be registered |
| 1 year (end of study) |
| Latency from admission to delivery | Latency from admission to delivery will be calculated | between initial admission and delivery (before 42 weeks of gestation) |
| IL-6 levels in amniotic fluid and umbilical cord blood | the investigators will determine the level of IL-6 in different samples | delivery (maximum 42 weeks of gestational age) |
| Number of emergency visits | Number of visits to emergency area will be registered | between initial admission and delivery (before 42 weeks of gestation) |
| Neonatal morbidity | neonatal morbidity will be registered:
| at the end of the study (1 year) |
| Neonatal death | Neonatal deaths will be registered | at the end of the study (1 year) |