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Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation
Plain-language guide to NCT02083809: not phased randomized trial of Oxytocin, 166 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02083809
- Phase
- not phased
- Status
- completed
- Start
- 2014-10
- Completion (planned or actual)
- 2018-02
- Participants
- 166 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Abortion; Dilation and Evacuation; Hemorrhage; Blood Loss
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Oxytocin.
To evaluate the hypothesis, investigators will perform a randomized, double-blinded, placebo-controlled trial.
It had two arms (groups): Placebo (placebo comparator) and Treatment group (active comparator).
Intravenous oxytocin mixed with saline or lactated ringer.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 166 actual participants took part.
It was open to women only aged from 14 years up to 50 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: patients requiring preoperative misoprostol.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
The Oxytocin group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2014-10 with completion listed for 2018-02.
It ran at 2 sites in United States (2).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures (time frame: During surgical procedure).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 166 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.