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| Name | Class |
|---|---|
| Santa Clara Valley Health & Hospital System | OTHER |
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Comparing nifedipine to placebo for the maintenance tocolysis of preterm labor
To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine | Active Comparator | Maintenance tocolysis with nifedipine. |
|
| Placebo | Placebo Comparator | Maintenance tocolysis with placebo tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine | Drug | Nifedipine 10 mg tablets, two tablets orally every 6 hours. Placebo tablets, two tablets orally every 6 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achieving 37 weeks gestation | delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of recurrent preterm labor | Delivery | |
| Neonatal outcomes | Discharge of neonate |
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Inclusion Criteria:
- arrested preterm labor
Exclusion Criteria:
- ruptured membranes, fetal distress, placenta previa, placental abruption, maternal medical contraindication to tocolysis
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Yehia El-Sayed | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19037029 | Result | Lyell DJ, Pullen KM, Mannan J, Chitkara U, Druzin ML, Caughey AB, El-Sayed YY. Maintenance nifedipine tocolysis compared with placebo: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1221-1226. doi: 10.1097/AOG.0b013e31818d8386. | |
| 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 |
| D020246 | Venous Thrombosis |
| 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 |
|---|---|
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |