Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03136068
Other study ID # Digoxin RCT
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 23, 2017
Est. completion date May 31, 2018

Study information

Verified date October 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 178
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Digoxin
Trans-abdominal injection
Placebo
Trans-abdominal injection

Locations

Country Name City State
United States FPA Women's Health Long Beach California
United States Lovejoy Surgicenter Portland Oregon
United States SFGH Women's Options Center San Francisco California

Sponsors (4)

Lead Sponsor Collaborator
University of California, San Francisco FPA Women’s Health, Oregon Health and Science University, Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Procedure Duration First instrument into uterus until procedure complete Beginning to end of procedure (between 5 minutes and 1 hour)
Secondary 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
Secondary 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
Secondary Number of Patients With Reported Fetal Death Prior to Procedure number of patients who had fetal death measured by ultrasound Day 2, before procedure
Secondary 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
See also
  Status Clinical Trial Phase
Terminated NCT00884403 - Gestational Age is Underestimated by Menstrual Dating Compared to Ultrasound Dating in Those Undergoing Abortion up to 20 Weeks
Completed NCT02083809 - Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation N/A
Completed NCT00986921 - Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks N/A
Completed NCT00769912 - Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia Phase 3
Completed NCT00235534 - Trial of Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Abortion N/A
Completed NCT06178224 - Determining Beta-hCG Levels in Patients Through Alternative Sample Types
Completed NCT04181021 - Evaluation of Values Clarification and Attitude Transformation Workshops on Abortion and Family Planning Service Provision and Client Experience N/A
Completed NCT01799252 - Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion N/A
Completed NCT00795314 - Propofol-butorphanol Anesthesia During Uterine Curettage Phase 4
Completed NCT02580175 - Surgical Evacuation of Abortion Under Ultrasonographic Guide Phase 2
Enrolling by invitation NCT03579550 - Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus N/A
Completed NCT01945385 - Impact of Video Intervention on Postabortal Uptake of Long Acting Reversible Contraception (LARC) N/A
Terminated NCT01436266 - Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion Phase 3
Completed NCT03227614 - Friends/Family in the Abortion Procedure Room (FAIR) N/A
Recruiting NCT03688581 - What is the Knowledge and Use of Emergency Contraception
Not yet recruiting NCT05471895 - Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
Completed NCT05688228 - Voluntary Interruption of Pregnancy on Women's Sexuality
Completed NCT04651166 - Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation Phase 2
Recruiting NCT05645614 - Anxiety and Pain During Intervention for Abortion Under Local Anesthesia
Completed NCT01807715 - Understanding Women's Contraceptive Expectations at the Time of a First Trimester Surgical Abortion