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No enrollment in past year, lack of interest
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| Name | Class |
|---|---|
| University Hospital | OTHER |
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Primary Hypothesis:
Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.
Primary Objective:
To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at <37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation.
Secondary Objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Intravenous magnesium sulfate or placebo |
|
| 2 | Active Comparator | Oral nifedipine or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulfate | Drug | Intravenous magnesium sulfate 6g bolus, then increased by 1 g/hour till a maximum of 5g/hour; gradually wean down to 2 g/hour for a total of 48 hours once uterine contractions is < 6/hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity | 4 years and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baha Sibai, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Cincinnati | Ohio | 45219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10796110 | Background | Crowley P. Prophylactic corticosteroids for preterm birth. Cochrane Database Syst Rev. 2000;(2):CD000065. doi: 10.1002/14651858.CD000065. | |
| 12519550 | Background | Crowther CA, Hiller JE, Doyle LW. Magnesium sulphate for preventing preterm birth in threatened preterm labour. Cochrane Database Syst Rev. 2002;(4):CD001060. doi: 10.1002/14651858.CD001060. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 14, 2011 | |
| Reset | Nov 23, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 14, 2011 | Nov 23, 2011 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| 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 |
|---|---|
| D008278 | Magnesium Sulfate |
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Oral Nifedipine or placebo | Drug | Oral nifedipine or placebo at 20 mg every 30 minutes for the first hour, then 20 mg every 3 to 6 hours not to exceed 180 mg in 24 hours, keep maintenance dose at 20 mg every 3 to 6 hours for a total of 48 hours if uterine contractions is < 6/hour. |
|
|
| 14714923 | Background | Huddleston JF, Sanchez-Ramos L, Huddleston KW. Acute management of preterm labor. Clin Perinatol. 2003 Dec;30(4):803-24, vii. doi: 10.1016/s0095-5108(03)00114-3. |
| 12535434 | Background | King JF, Flenady VJ, Papatsonis DN, Dekker GA, Carbonne B. Calcium channel blockers for inhibiting preterm labour. Cochrane Database Syst Rev. 2003;(1):CD002255. doi: 10.1002/14651858.CD002255. |
| 8333483 | Background | Morales WJ, Madhav H. Efficacy and safety of indomethacin compared with magnesium sulfate in the management of preterm labor: a randomized study. Am J Obstet Gynecol. 1993 Jul;169(1):97-102. doi: 10.1016/0002-9378(93)90138-9. |
| 10725475 | Background | Papatsonis DN, Kok JH, van Geijn HP, Bleker OP, Ader HJ, Dekker GA. Neonatal effects of nifedipine and ritodrine for preterm labor. Obstet Gynecol. 2000 Apr;95(4):477-81. doi: 10.1016/s0029-7844(99)00596-7. |
| 11561911 | Background | Ramsey PS, Rouse DJ. Magnesium sulfate as a tocolytic agent. Semin Perinatol. 2001 Aug;25(4):236-47. doi: 10.1053/sper.2001.27546. |
| 8238157 | Result | Glock JL, Morales WJ. Efficacy and safety of nifedipine versus magnesium sulfate in the management of preterm labor: a randomized study. Am J Obstet Gynecol. 1993 Oct;169(4):960-4. doi: 10.1016/0002-9378(93)90035-h. |
| 10580682 | Result | Haghighi L. Prevention of preterm delivery: nifedipine or magnesium sulfate. Int J Gynaecol Obstet. 1999 Sep;66(3):297-8. doi: 10.1016/s0020-7292(99)00095-8. |
| 10601925 | Result | Larmon JE, Ross BS, May WL, Dickerson GA, Fischer RG, Morrison JC. Oral nicardipine versus intravenous magnesium sulfate for the treatment of preterm labor. Am J Obstet Gynecol. 1999 Dec;181(6):1432-7. doi: 10.1016/s0002-9378(99)70388-1. |
| 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. |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |