Abortion, Blood Loss, Dilation and Evacuation, Hemorrhage
Conditions
Brief summary
Currently, there is very little research to identify ways to decrease blood loss during D&E (dilation and evacuation) procedures. The objective is to determine whether routine use of intravenous oxytocin will improve bleeding outcomes at the time of D&E at 18-24-weeks gestation. To evaluate the hypothesis, investigators will perform a randomized, double-blinded, placebo-controlled trial. The patient will be followed until discharged from the postoperative care unit during which time patient satisfaction, pain score and postoperative bleeding will be assessed.
Interventions
30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
DRUGIntravenous Fluids and Electrolytes
500 ml of inert IV fluid
Sponsors
Society of Family Planning
University of Washington
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Requesting pregnancy termination * Intrauterine pregnancy at 18- to 24-weeks gestation * Gestational-age to be confirmed by ultrasound * Patients with fetal anomaly or intrauterine fetal demise that occurred at 18- to 24-weeks gestation * Willing and able to understand and sign written informed consents in English or Spanish and comply with study procedures
Exclusion criteria
* Ultrasound findings suggestive of placenta accreta * Patients requiring preoperative misoprostol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. | During surgical procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 500ml saline or lactated ringer without oxytocin added
Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid | 78 |
| Treatment Group Intravenous oxytocin mixed with saline or lactated ringer
intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer) | 82 |
| Total | 160 |
Baseline characteristics
| Characteristic | Treatment Group | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 25.4 age STANDARD_DEVIATION 7 | 26.3 age STANDARD_DEVIATION 7.1 | 27.2 age STANDARD_DEVIATION 7.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 27 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 15 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 27 Participants | 50 Participants | 23 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 68 Participants | 36 Participants |
| Sex: Female, Male Female | 82 Participants | 160 Participants | 78 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 82 |
| other Total, other adverse events | 0 / 78 | 0 / 82 |
| serious Total, serious adverse events | 1 / 78 | 1 / 82 |
Outcome results
Primary
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
Time frame: During surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. | 13 Participants |
| Treatment Group | Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. | 6 Participants |