Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation
ConditionHemorrhage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
clinic-based D&E at 18 weeks gestational age and above
speaks English or Spanish
Disqualifiers
refuses IV
history of coagulopathy
anticoagulant use in the preceding five days
chorioamnionitis or sepsis
Trial design
Design model
Parallel
Treatments tested in this trial
Oxytocin + normal saline
Drug40 units IV oxytocin once in a 1000 mL bag of normal saline
Normal saline
Drug1000 mL bag of normal saline alone
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: OxytocinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hemorrhage
Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission
Time frame
day of procedure2
Quantitative blood loss
Measured blood loss during procedure
Time frame
day of procedureSecondary outcomes
1
Procedure time
Length of time of total procedure and length of time until bleeding initially managed
Time frame
day of procedureOther outcomes
1
Patient satisfaction and pain scores
Patient satisfaction with procedure and maximum reported pain on a visual analog scale
Time frame
day of procedure2
Ease of procedure
Provider reported ease of procedure
Time frame
day of procedure3
Rate of additional uterotonics
Report of additional medications to treat bleeding used
Time frame
day of procedure4
Cost of additional uterotonics
Estimated cost of additional uterotonics used
Time frame
day of procedureSponsors and contacts
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Source ClinicalTrials.gov