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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The purpose of our study is to determine the optimum route for the injection of digoxin prior to second-trimester surgical abortion.
Of the 1.2 million abortions each year in the U.S., approximately 12% take place in the second trimester of pregnancy. The preferred technique for second-trimester pregnancy termination is dilation and evacuation, or D&E. In 2006, 144,000 D&Es were performed in the U.S. Clinicians often achieve preoperative fetal asystole by a maternal transabdominal injection of digoxin. Prior to D&E, providers use digoxin to induce fetal death 1) for providers' preference to facilitate surgical delivery of the fetus, and/or 2) for patients who express a desire for fetal death prior to the abortion.
The use of digoxin to achieve preoperative fetal asystole is widespread, yet there are no evidence-based standards for how to best achieve fetal asystole prior to D&E. Digoxin has been administered by intracardiac, intrathoracic, intrafetal and intra-amniotic routes, with doses varying from 0.25 to 2mg. Clinicians who use digoxin usually inject it one to two days before the D&E. Only one study has assessed the effectiveness of digoxin at varying dosages ; this was a retrospective and nonrandomized analysis. Published failure rates are based on small numbers of patients and are therefore imprecise. Intrafetal digoxin injection may be more effective, but is a technically more difficult procedure than intra-amniotic injection. The pharmacodynamics of digoxin when used for feticide are also unknown. The objective of this study is to determine the optimum route for digoxin injection (intrafetal or intra-amniotic) that will maximize patient safety while maintaining effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intra-fetal injection | Active Comparator | Subjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion |
|
| intra-amniotic injection | Active Comparator | Subjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-fetal digoxin injection | Drug | Single transabdominal injection of digoxin 1 mg into the fetus |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference in fetal asystole rates between groups | one day |
| Measure | Description | Time Frame |
|---|---|---|
| digoxin-related side effects | one day | |
| differences in surgical procedure between groups | one day | |
| subject satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharine O White, MD, MPH | Physicians for Reproductive Choice and Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Los Angeles - Bixby Health Center | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11239659 | Background | Jackson RA, Teplin VL, Drey EA, Thomas LJ, Darney PD. Digoxin to facilitate late second-trimester abortion: a randomized, masked, placebo-controlled trial. Obstet Gynecol. 2001 Mar;97(3):471-6. doi: 10.1016/s0029-7844(00)01148-0. | |
| 18279695 | Background | Molaei M, Jones HE, Weiselberg T, McManama M, Bassell J, Westhoff CL. Effectiveness and safety of digoxin to induce fetal demise prior to second-trimester abortion. Contraception. 2008 Mar;77(3):223-5. doi: 10.1016/j.contraception.2007.10.011. Epub 2008 Jan 22. |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| intra-amniotic digoxin injection | Drug | Single transabdominal injection of digoxin 1 mg into the amniotic fluid |
|
|
| one day |
| serum digoxin levels in study subgroup | one day |
| 10819828 | Background | Drey EA, Thomas LJ, Benowitz NL, Goldschlager N, Darney PD. Safety of intra-amniotic digoxin administration before late second-trimester abortion by dilation and evacuation. Am J Obstet Gynecol. 2000 May;182(5):1063-6. doi: 10.1067/mob.2000.105438. |
| 27741192 | Derived | White KO, Nucatola DL, Westhoff C. Intra-fetal Compared With Intra-amniotic Digoxin Before Dilation and Evacuation: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1071-1076. doi: 10.1097/AOG.0000000000001671. |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |