Trial Outcomes & Findings for Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation (NCT NCT03136068)

NCT ID: NCT03136068

Last Updated: 2019-10-30

Results Overview

First instrument into uterus until procedure complete

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 178 participants
• Primary outcome timeframe: Beginning to end of procedure (between 5 minutes and 1 hour)
• Results posted on: 2019-10-30

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Digoxin Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Digoxin n=88 Participants Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo n=90 Participants Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection	Total n=178 Participants Total of all reporting groups
Age, Continuous	27.3 years STANDARD_DEVIATION 6.7 • n=5 Participants	26.2 years STANDARD_DEVIATION 5.6 • n=7 Participants	26.8 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	90 Participants n=7 Participants	178 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian, non-Hispanic	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized African-American, non-Hispanic	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Mixed/Multi	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Body mass index (BMI)	27.2 kg/m2 STANDARD_DEVIATION 5.6 • n=5 Participants	26.7 kg/m2 STANDARD_DEVIATION 5.2 • n=7 Participants	26.9 kg/m2 STANDARD_DEVIATION 5.4 • n=5 Participants
Nulliparous	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Gestational duration	21.1 weeks n=5 Participants	21.0 weeks n=7 Participants	21.0 weeks n=5 Participants

PRIMARY outcome

Timeframe: Beginning to end of procedure (between 5 minutes and 1 hour)

Population: Duration of procedure time from speculum insertion to procedure completion

First instrument into uterus until procedure complete

Outcome measures

Measure	Digoxin n=86 Participants Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo n=89 Participants Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Procedure Duration	6.8 minutes Standard Deviation 4.8	7.2 minutes Standard Deviation 6.9

SECONDARY outcome

Timeframe: done on Day 2 during the procedure

Population: 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

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

Outcome measures

Measure	Digoxin n=86 Participants Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo n=89 Participants Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Total Procedure Duration	9.7 minutes Standard Deviation 9.3	8.3 minutes Standard Deviation 7.9

SECONDARY outcome

Timeframe: Day 2, during the procedure

Population: 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

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

Outcome measures

Measure	Digoxin n=33 Participants Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo n=28 Participants Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Measured Blood Loss	417 mL Interval 305.0 to 527.0	363 mL Interval 279.0 to 522.0

SECONDARY outcome

Timeframe: Day 2, before procedure

Population: number of patients who had reported fetal death on day 2

number of patients who had fetal death measured by ultrasound

Outcome measures

Measure	Digoxin n=86 Participants Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo n=89 Participants Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Number of Patients With Reported Fetal Death Prior to Procedure	68 Participants	6 Participants

SECONDARY outcome

Timeframe: Day 2

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

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

Outcome measures

Measure	Digoxin n=89 Participants Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo n=86 Participants Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Complications	8 Participants	4 Participants

Adverse Events

Digoxin

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Digoxin n=86 participants at risk Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo n=89 participants at risk Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Blood and lymphatic system disorders blood transfusion	0.00% 0/86 • two days, day one and day two does not differ from clinicaltrials.gov	1.1% 1/89 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov

Other adverse events

Measure	Digoxin n=86 participants at risk Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection	Placebo n=89 participants at risk Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection
Pregnancy, puerperium and perinatal conditions pregnancy labor	1.2% 1/86 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov	0.00% 0/89 • two days, day one and day two does not differ from clinicaltrials.gov
Gastrointestinal disorders severe nausea	1.2% 1/86 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov	0.00% 0/89 • two days, day one and day two does not differ from clinicaltrials.gov
Blood and lymphatic system disorders hemmorhage	2.3% 2/86 • Number of events 2 • two days, day one and day two does not differ from clinicaltrials.gov	0.00% 0/89 • two days, day one and day two does not differ from clinicaltrials.gov
Nervous system disorders anxiety	0.00% 0/86 • two days, day one and day two does not differ from clinicaltrials.gov	1.1% 1/89 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov
Reproductive system and breast disorders cramping	1.2% 1/86 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov	1.1% 1/89 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov
General disorders fever	1.2% 1/86 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov	0.00% 0/89 • two days, day one and day two does not differ from clinicaltrials.gov
Reproductive system and breast disorders mass	0.00% 0/86 • two days, day one and day two does not differ from clinicaltrials.gov	1.1% 1/89 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov
Gastrointestinal disorders vomiting	1.2% 1/86 • Number of events 1 • two days, day one and day two does not differ from clinicaltrials.gov	0.00% 0/89 • two days, day one and day two does not differ from clinicaltrials.gov

Additional Information

Director of Clinical Trials

UCSF

Phone: 414-206-8715

Email: abby.sokoloff@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place