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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT03136068
• Collaborator: FPA Women's Health (Other), Society of Family Planning (Other), Oregon Health and Science University (Other)
• Enrollment: 178
• Locations: 3
• Arms: 2
• Actual Duration (Months): 15.2
• Patients Per Site: 59.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Abortion	Drug: Digoxin; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 178 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation: a Placebo-controlled, Double-blinded Randomized Controlled Trial
• Actual Study Start Date: Feb 23, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Procedure Duration [Beginning to end of procedure (between 5 minutes and 1 hour)]

   First instrument into uterus until procedure complete

Secondary Outcome Measures

1. Total Procedure Duration [done on Day 2 during the procedure]

   Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything

2. Measured Blood Loss [Day 2, during the procedure]

   measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood

3. Number of Patients With Reported Fetal Death Prior to Procedure [Day 2, before procedure]

   number of patients who had fetal death measured by ultrasound

4. Complications [Day 2]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FPA Women's Health	Long Beach	California	United States	90806
2	SFGH Women's Options Center	San Francisco	California	United States	94110
3	Lovejoy Surgicenter	Portland	Oregon	United States	97210

Sponsors and Collaborators

• University of California, San Francisco
• FPA Women's Health
• Society of Family Planning
• Oregon Health and Science University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 13, 2017

More Information

Publications

None provided.

• Responsible Party: Jennifer Kerns, MD, MS, MPH, Assistant Professor department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03136068
• Other Study ID Numbers: Digoxin RCT
• First Posted: May 2, 2017
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dilatation, Pathologic; Digoxin

Study Results

Participant Flow

Arm/Group Title	Digoxin	Placebo
Arm/Group Description	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Period Title: Overall Study
STARTED	88	90
COMPLETED	86	89
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Digoxin	Placebo	Total
Arm/Group Description	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection	Total of all reporting groups
Overall Participants	88	90	178
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.3 (6.7)	26.2 (5.6)	26.8 (6.2)
Sex: Female, Male (Count of Participants)
Female	88 100%	90 100%	178 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian, non-Hispanic	26 29.5%	30 33.3%	56 31.5%
Hispanic	28 31.8%	31 34.4%	59 33.1%
African-American, non-Hispanic	17 19.3%	17 18.9%	34 19.1%
Mixed/Multi	8 9.1%	8 8.9%	16 9%
Other	9 10.2%	4 4.4%	13 7.3%
Body mass index (BMI) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	27.2 (5.6)	26.7 (5.2)	26.9 (5.4)
Nulliparous (Count of Participants)
Count of Participants [Participants]	21 23.9%	15 16.7%	36 20.2%
Gestational duration (weeks) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [weeks]	21.1	21.0	21.0

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Duration of procedure time from speculum insertion to procedure completion

Arm/Group Title	Digoxin	Placebo
Arm/Group Description	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Measure Participants	86	89
Mean (Standard Deviation) [minutes]	6.8 (4.8)	7.2 (6.9)

2. Secondary Outcome

Title	Total Procedure Duration
Description	Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything
Time Frame	done on Day 2 during the procedure

Outcome Measure Data

Analysis Population Description

duration of procedure for each participant from insertion of speculum to total procedure completion, including any post-procedure activities prior to being taken to recovery

Arm/Group Title	Digoxin	Placebo
Arm/Group Description	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Measure Participants	86	89
Mean (Standard Deviation) [minutes]	9.7 (9.3)	8.3 (7.9)

3. Secondary Outcome

Title	Measured Blood Loss
Description	measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood
Time Frame	Day 2, during the procedure

Outcome Measure Data

Analysis Population Description

measured blood loss was only completed at the Zuckerberg San Francisco General Hospital location, which is why the total is 61 rather than 175 for this outcome

Arm/Group Title	Digoxin	Placebo
Arm/Group Description	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Measure Participants	33	28
Median (Inter-Quartile Range) [mL]	417	363

4. Secondary Outcome

Title	Number of Patients With Reported Fetal Death Prior to Procedure
Description	number of patients who had fetal death measured by ultrasound
Time Frame	Day 2, before procedure

Outcome Measure Data

Analysis Population Description

number of patients who had reported fetal death on day 2

Arm/Group Title	Digoxin	Placebo
Arm/Group Description	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Measure Participants	86	89
Count of Participants [Participants]	68 77.3%	6 6.7%

5. Secondary Outcome

Title	Complications
Description	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
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

any complication reported by patient; may have reported more than one complication

Arm/Group Title	Digoxin	Placebo
Arm/Group Description	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Measure Participants	89	86
Count of Participants [Participants]	8 9.1%	4 4.4%

Adverse Events

Time Frame	two days, day one and day two
Adverse Event Reporting Description	does not differ from clinicaltrials.gov
Arm/Group Title	Digoxin		Placebo
Arm/Group Description	Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection		Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
All Cause Mortality
	Digoxin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		0/89 (0%)
Serious Adverse Events
	Digoxin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/86 (0%)		1/89 (1.1%)
Blood and lymphatic system disorders
blood transfusion	0/86 (0%)	0	1/89 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Digoxin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/86 (8.1%)		3/89 (3.4%)
Blood and lymphatic system disorders
hemmorhage	2/86 (2.3%)	2	0/89 (0%)	0
Gastrointestinal disorders
severe nausea	1/86 (1.2%)	1	0/89 (0%)	0
vomiting	1/86 (1.2%)	1	0/89 (0%)	0
General disorders
fever	1/86 (1.2%)	1	0/89 (0%)	0
Nervous system disorders
anxiety	0/86 (0%)	0	1/89 (1.1%)	1
Pregnancy, puerperium and perinatal conditions
pregnancy labor	1/86 (1.2%)	1	0/89 (0%)	0
Reproductive system and breast disorders
cramping	1/86 (1.2%)	1	1/89 (1.1%)	1
mass	0/86 (0%)	0	1/89 (1.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.