Digoxin to facilitate late second-trimester abortion: a randomized, masked, placebo-controlled trial
Objective: To examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions. Methods: We performed a randomized, double-masked, placebo-controlled trial of intra-amniotic digoxin for second-trimester dilation and evacuation (D&E)...
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| Published in | Obstetrics and gynecology (New York. 1953) Vol. 97; no. 3; pp. 471 - 476 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York, NY
Elsevier Inc
01.03.2001
The American College of Obstetricians and Gynecologists Elsevier Science |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0029-7844 1873-233X |
| DOI | 10.1016/S0029-7844(00)01148-0 |
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| Abstract | Objective: To examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions.
Methods: We performed a randomized, double-masked, placebo-controlled trial of intra-amniotic digoxin for second-trimester dilation and evacuation (D&E) involving 126 consecutive women at an inner-city public hospital. Eligible women had gestational ages of 20–23.1 weeks, spoke English or Spanish, and were at least 16 years old. Digoxin (1 mg) or saline was injected intra-amniotically 24 hours before the procedure, at cervical laminaria insertion. The primary outcome was procedure duration. Sample size was based on 80% power to detect a difference of 3.5 minutes between groups.
Results: The two groups were similar in demographic factors, obstetric histories, and gestational duration. The average gestational length was 22.5 weeks. There was no difference in procedure duration (mean ± standard deviation) between groups (placebo 14.7 ± 7.0, digoxin 15.4 ± 8.0). There were no differences in blood loss estimated by surgeons, pain scores, procedure difficulty scores, or complications between groups. Vomiting was significantly more common in those who received digoxin (placebo 3.1%, digoxin 16.1%). Most subjects (91%) reported that they preferred their fetuses were dead before the abortions.
Conclusion: Although digoxin did not increase efficacy of late second-trimester abortion, patient preference might justify its use. |
|---|---|
| AbstractList | OBJECTIVETo examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions.
METHODSWe performed a randomized, double-masked, placebo-controlled trial of intra-amniotic digoxin for second-trimester dilation and evacuation (D&E) involving 126 consecutive women at an inner-city public hospital. Eligible women had gestational ages of 20–23.1 weeks, spoke English or Spanish, and were at least 16 years old. Digoxin (1 mg) or saline was injected intra-amniotically 24 hours before the procedure, at cervical laminaria insertion. The primary outcome was procedure duration. Sample size was based on 80% power to detect a difference of 3.5 minutes between groups.
RESULTSThe two groups were similar in demographic factors, obstetric histories, and gestational duration. The average gestational length was 22.5 weeks. There was no difference in procedure duration (mean ± standard deviation) between groups (placebo 14.7 ± 7.0, digoxin 15.4 ± 8.0). There were no differences in blood loss estimated by surgeons, pain scores, procedure difficulty scores, or complications between groups. Vomiting was significantly more common in those who received digoxin (placebo 3.1%, digoxin 16.1%). Most subjects (91%) reported that they preferred their fetuses were dead before the abortions.
CONCLUSIONAlthough digoxin did not increase efficacy of late second-trimester abortion, patient preference might justify its use. Objective: To examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions. Methods: We performed a randomized, double-masked, placebo-controlled trial of intra-amniotic digoxin for second-trimester dilation and evacuation (D&E) involving 126 consecutive women at an inner-city public hospital. Eligible women had gestational ages of 20–23.1 weeks, spoke English or Spanish, and were at least 16 years old. Digoxin (1 mg) or saline was injected intra-amniotically 24 hours before the procedure, at cervical laminaria insertion. The primary outcome was procedure duration. Sample size was based on 80% power to detect a difference of 3.5 minutes between groups. Results: The two groups were similar in demographic factors, obstetric histories, and gestational duration. The average gestational length was 22.5 weeks. There was no difference in procedure duration (mean ± standard deviation) between groups (placebo 14.7 ± 7.0, digoxin 15.4 ± 8.0). There were no differences in blood loss estimated by surgeons, pain scores, procedure difficulty scores, or complications between groups. Vomiting was significantly more common in those who received digoxin (placebo 3.1%, digoxin 16.1%). Most subjects (91%) reported that they preferred their fetuses were dead before the abortions. Conclusion: Although digoxin did not increase efficacy of late second-trimester abortion, patient preference might justify its use. To examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions.OBJECTIVETo examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions.We performed a randomized, double-masked, placebo-controlled trial of intra-amniotic digoxin for second-trimester dilation and evacuation (D&E) involving 126 consecutive women at an inner-city public hospital. Eligible women had gestational ages of 20-23.1 weeks, spoke English or Spanish, and were at least 16 years old. Digoxin (1 mg) or saline was injected intra-amniotically 24 hours before the procedure, at cervical laminaria insertion. The primary outcome was procedure duration. Sample size was based on 80% power to detect a difference of 3.5 minutes between groups.METHODSWe performed a randomized, double-masked, placebo-controlled trial of intra-amniotic digoxin for second-trimester dilation and evacuation (D&E) involving 126 consecutive women at an inner-city public hospital. Eligible women had gestational ages of 20-23.1 weeks, spoke English or Spanish, and were at least 16 years old. Digoxin (1 mg) or saline was injected intra-amniotically 24 hours before the procedure, at cervical laminaria insertion. The primary outcome was procedure duration. Sample size was based on 80% power to detect a difference of 3.5 minutes between groups.The two groups were similar in demographic factors, obstetric histories, and gestational duration. The average gestational length was 22.5 weeks. There was no difference in procedure duration (mean +/- standard deviation) between groups (placebo 14.7 +/- 7.0, digoxin 15.4 +/- 8.0). There were no differences in blood loss estimated by surgeons, pain scores, procedure difficulty scores, or complications between groups. Vomiting was significantly more common in those who received digoxin (placebo 3.1%, digoxin 16.1%). Most subjects (91%) reported that they preferred their fetuses were dead before the abortions.RESULTSThe two groups were similar in demographic factors, obstetric histories, and gestational duration. The average gestational length was 22.5 weeks. There was no difference in procedure duration (mean +/- standard deviation) between groups (placebo 14.7 +/- 7.0, digoxin 15.4 +/- 8.0). There were no differences in blood loss estimated by surgeons, pain scores, procedure difficulty scores, or complications between groups. Vomiting was significantly more common in those who received digoxin (placebo 3.1%, digoxin 16.1%). Most subjects (91%) reported that they preferred their fetuses were dead before the abortions.Although digoxin did not increase efficacy of late second-trimester abortion, patient preference might justify its use.CONCLUSIONAlthough digoxin did not increase efficacy of late second-trimester abortion, patient preference might justify its use. To examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions. We performed a randomized, double-masked, placebo-controlled trial of intra-amniotic digoxin for second-trimester dilation and evacuation (D&E) involving 126 consecutive women at an inner-city public hospital. Eligible women had gestational ages of 20-23.1 weeks, spoke English or Spanish, and were at least 16 years old. Digoxin (1 mg) or saline was injected intra-amniotically 24 hours before the procedure, at cervical laminaria insertion. The primary outcome was procedure duration. Sample size was based on 80% power to detect a difference of 3.5 minutes between groups. The two groups were similar in demographic factors, obstetric histories, and gestational duration. The average gestational length was 22.5 weeks. There was no difference in procedure duration (mean +/- standard deviation) between groups (placebo 14.7 +/- 7.0, digoxin 15.4 +/- 8.0). There were no differences in blood loss estimated by surgeons, pain scores, procedure difficulty scores, or complications between groups. Vomiting was significantly more common in those who received digoxin (placebo 3.1%, digoxin 16.1%). Most subjects (91%) reported that they preferred their fetuses were dead before the abortions. Although digoxin did not increase efficacy of late second-trimester abortion, patient preference might justify its use. |
| Author | Drey, Eleanor A Darney, Philip D Jackson, Rebecca A Teplin, Vanessa L Thomas, Lisa J |
| AuthorAffiliation | Center for Reproductive Health Research and Policy, San Francisco General Hospital, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California |
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| Keywords | Second trimester Facilitation Human Digoxin Induced abortion Controlled therapeutic trial Duration Operation Chemotherapy Randomization Pain Double blind study Female Influence Glycoside Digitalis drug |
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| References | Hern, Zen, Ferguson, Hart, Haseman (BIB3) 1993; 81 Hern (BIB6) 1984; 63 Shulman, Ling, Meyers, Shanklin, Simpson, Elias (BIB7) 1990; 75 Koonin, Strauss, Chrisman, Montalbano, Bartlett, Smith (BIB1) 1998; 48 Grimes, Schulz (BIB4) 1985; 30 Drey, Thomas, Benowitz, Goldschlager, Darney (BIB5) 2000; 182 Lawson, Frye, Atrash, Smith, Shulman, Ramick (BIB2) 1994; 171 |
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| Snippet | Objective: To examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions.
Methods: We... OBJECTIVETo examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions. METHODSWe... To examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions. We performed a randomized,... To examine the efficacy of digoxin for decreasing operative time, difficulty, and pain of late second-trimester surgical abortions.OBJECTIVETo examine the... |
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| SubjectTerms | Abortifacient Agents - administration & dosage Abortion, Induced Adolescent Adult Amniotic Fluid Biological and medical sciences Digoxin - administration & dosage Double-Blind Method Female Genital system. Reproduction Humans Medical sciences Patient Satisfaction Pharmacology. Drug treatments Pregnancy Pregnancy Trimester, Second Time Factors |
| Title | Digoxin to facilitate late second-trimester abortion: a randomized, masked, placebo-controlled trial |
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