Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

Study Overview
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Brief Summary
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Current practice for the provision of late second trimester abortion (dilation and evacuation, or D&E) often involves the administration of digoxin into the fetal compartment to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally or transvaginally into the fetal compartment. Both modes of administration have been shown in prospective studies to be highly effective and safe. Both modes of administration are considered standard of care. This pilot study will directly compare transabdominal and transvaginal digoxin with respect to patient preference (i.e, patient pain score describing discomfort with injection).

Official Title
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Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion: a Pilot Study of Patient Preference

Conditions
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Abortion, Induced

Intervention / Treatment
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* Drug: Digoxin (transvaginal administration)
* Drug: Digoxin (transabdominal administration)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years Singleton viable gestation Identifying as primarily English-speaking Body mass index less than 40 kilograms/meters squared Already a consented patient for second-trimester abortion procedure with digoxin to be performed for termination of pregnancy at the study site No medical contraindication to digoxin (i.e., no cardiac dysfunction, no renal dysfunction, no hypersensitivity to digoxin)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transvaginal digoxin<br>Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion | Drug: Digoxin (transvaginal administration)<br>* Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.<br>|
| Other: Transabdominal digoxin<br>Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion | Drug: Digoxin (transabdominal administration)<br>* Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Discomfort With Digoxin Injection (Pain Score) | Pain score (indicated by patient reporting pain level from 0 (no hurt) to 5 (hurts worst) at time of digoxin injection) | At time of study (immediate) |