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| ID | Type | Description | Link |
|---|---|---|---|
| CHREB #16682 |
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Breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. As an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ECV).
Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials.
This study is designed to answer the following questions for multiparous women:
Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates? Will an increase in ECV success result in a decreased cesarean section rate?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Placebo solution was normal saline. After an initial 1mL dose, further doses could be given in 1-3mL increments until uterine relaxation was achieved, or up to a recommended maximum of 10mL. |
|
| 1 | Active Comparator | Treatment solution consisted of 100micrograms/mL of nitroglycerin. After an initial 1mL dose, further doses could be given in 1-3mL increments until uterine relaxation was achieved, or up to a recommended maximum of 10mL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Nitroglycerin | Drug | IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of ECV (if fetus turned from Breech to cephalic) at end of ECV procedure | Recorded at the end of ECV attempt |
| Measure | Description | Time Frame |
|---|---|---|
| Success of ECV (ie fetus in cephalic presentation) recorded at time of delivery | Recorded at time of birth | |
| Mode of delivery | Recorded at time of birth | |
| Maternal side effects and adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce B Allan, MD PhD | Calgary Health Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 4J8 | Canada | ||
| Peter Lougheed Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19701035 | Result | Hilton J, Allan B, Swaby C, Wah R, Jarrell J, Wood S, Ross S, Tran Q. Intravenous nitroglycerin for external cephalic version: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):560-567. doi: 10.1097/AOG.0b013e3181b05a19. |
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| ID | Term |
|---|---|
| D001946 | Breech Presentation |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| Normal saline | Drug | IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL |
|
| Recorded until date of birth (up to 3 weeks' duration). |
| Calgary |
| Alberta |
| Canada |
| Rockyview Hospital | Calgary | Alberta | Canada |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |