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Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

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University of Hawaii

Status

Completed

Conditions

Abortion
Hemorrhage
Dilation and Evacuation
Blood Loss

Treatments

Drug: intravenous oxytocin
Drug: Intravenous Fluids and Electrolytes

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

Female

Ages

14 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

166 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
500ml saline or lactated ringer without oxytocin added
Treatment:
Drug: Intravenous Fluids and Electrolytes
Treatment group
Active Comparator group
Description:
Intravenous oxytocin mixed with saline or lactated ringer
Treatment:
Drug: intravenous oxytocin

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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