Hemorrhage
Conditions
Brief summary
The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D&E) in the clinic setting.
Interventions
DRUGOxytocin + normal saline
40 units IV oxytocin once in a 1000 mL bag of normal saline
DRUGNormal saline
1000 mL bag of normal saline alone
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This will be a double blinded study.
Intervention model description
Randomized controlled trial - randomized to either receive treatment (40 units IV oxytocin + 1000 mL normal saline) or placebo (1000 mL normal saline alone).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* clinic-based D&E at 18 weeks gestational age and above * speaks English or Spanish
Exclusion criteria
* refuses IV * history of coagulopathy * anticoagulant use in the preceding five days * chorioamnionitis or sepsis * suspected placenta accreta spectrum * intrauterine fetal demise * multiple gestation * use of misoprostol for cervical preparation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhage | day of procedure | Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission |
| Quantitative blood loss | day of procedure | Measured blood loss during procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | day of procedure | Length of time of total procedure and length of time until bleeding initially managed |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost of additional uterotonics | day of procedure | Estimated cost of additional uterotonics used |
| Rate of additional uterotonics | day of procedure | Report of additional medications to treat bleeding used |
| Patient satisfaction and pain scores | day of procedure | Patient satisfaction with procedure and maximum reported pain on a visual analog scale |
| Ease of procedure | day of procedure | Provider reported ease of procedure |
Countries
United States
Contacts
Primary ContactMegan Masten, MD
Outcome results
None listed