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N/A N=166 Randomized Quadruple-blind Treatment

Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

Abortion · Dilation and Evacuation · Hemorrhage · Blood Loss

Enrolled (actual)
166
Serious AEs
1.3%
Results posted
Nov 2020
Primary outcome: Primary: Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. — 13; 6 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
intravenous oxytocin (Drug); Intravenous Fluids and Electrolytes (Drug)
Age
Pediatric, Adult · 14+ yrs
Sex
Female
Sponsor
University of Hawaii
Primary completion
Feb 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
13; 6

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02083809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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