Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation

Study Overview
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Brief Summary
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This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D&E procedure, but doctors want to clarify how digoxin effects D&E procedure time, if at all.

Official Title
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Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial

Conditions
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Abortion

Intervention / Treatment
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* Drug: Digoxin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 weeks 0 days-24 weeks 0 days gestation English or Spanish speaking 18 years or older Exclusion Criteria: Under 18 Contraindications 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digoxin<br>Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance | Drug: Digoxin<br>* Trans-abdominal injection<br>|
| Placebo Comparator: Placebo<br>Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume | Drug: Placebo<br>* Trans-abdominal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Duration | First instrument into uterus until procedure complete | Beginning to end of procedure (between 5 minutes and 1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Procedure Duration | Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything | done on Day 2 during the procedure | 
| Measured Blood Loss | measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood | Day 2, during the procedure | 
| Number of Patients With Reported Fetal Death Prior to Procedure | number of patients who had fetal death measured by ultrasound | Day 2, before procedure | 
| Complications | hemorrhage, perforation, cervical laceration requiring suture repair, out-of-hospital delivery, infection, inability to complete injection, other complications of the injection itself, and patient symptoms such as nausea and vomiting | Day 2 |