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The objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. All patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation.
The primary outcome for the trial is the length of pregnancy in days after the enrollment. A sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | Placebo three times daily |
|
| B | Experimental | 20 mg of slow-release Nifedipine three times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo three times daily |
| |
| Nifedipine |
| Measure | Description | Time Frame |
|---|---|---|
| Prolongation of pregnancy | From allocation to the delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required | At the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Rouen | Rouen | 76031 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37717697 | Derived | Verspyck E, Thill C, Ego A, Machevin E, Brasseur-Daudruy M, Ickowicz V, Blondel C, Degre S, Lefebure A, Braund S, Benichou J. Screening for small for gestational age infants in early vs late third-trimester ultrasonography: a randomized trial. Am J Obstet Gynecol MFM. 2023 Nov;5(11):101162. doi: 10.1016/j.ajogmf.2023.101162. Epub 2023 Sep 15. | |
| 35947046 |
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| ID | Term |
|---|---|
| D010923 | Placenta Previa |
| 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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| Drug |
20 mg of slow-release Nifedipine three times daily |
|
| 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. |
| 28333939 | Derived | Verspyck E, de Vienne C, Muszynski C, Bubenheim M, Chanavaz-Lacheray I, Dreyfus M, Deruelle P, Benichou J. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial. PLoS One. 2017 Mar 23;12(3):e0173717. doi: 10.1371/journal.pone.0173717. eCollection 2017. |
| D010922 | Placenta Diseases |