AbortionNCT02083809
Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation
A study testing intravenous oxytocin and Intravenous Fluids and Electrolytes in people with Abortion and Dilation and Evacuation, run by University of Hawaii at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Abortion, Dilation and Evacuation, Hemorrhage
- What is being tested?
- intravenous oxytocin and Intravenous Fluids and Electrolytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to 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
Who cannot join
- Ultrasound findings suggestive of placenta accreta
- Patients requiring preoperative misoprostol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Hawaii
Honolulu, Hawaii, 96826
University of Washington
Seattle, Washington, 98104
About this study
Official title: A Randomized Double-blinded Controlled Trial Comparing Dilation and Evacuation Outcomes With and Without Oxytocin Use
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.
- Conditions
- Abortion, Dilation and Evacuation, Hemorrhage, Blood Loss
- Being tested
- intravenous oxytocin, Intravenous Fluids and Electrolytes
- Medical subject headings
- Dilatation, Pathologic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous oxytocinDrug
30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
Intravenous Fluids and ElectrolytesDrug
500 ml of inert IV fluid
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 500ml saline or lactated ringer without oxytocin added Receives: Drug: Intravenous Fluids and Electrolytes |
| Treatment group | Active comparator | Intravenous oxytocin mixed with saline or lactated ringer Receives: Drug: intravenous oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning, University of Washington
- Responsible party
- Principal investigator, Bliss Kaneshiro, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083809
- Sponsor's protocol ID
- OxyDE
- Status last verified
- Nov 2020
- First submitted
- 4 Mar 2014
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Whitehouse K, Tschann M, Soon R, Davis J, Micks E, Salcedo J, Savala M, Kaneshiro B. Effects of Prophylactic Oxytocin on Bleeding Outcomes in Women Undergoing Dilation and Evacuation: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):484-491. doi: 10.1097/AOG.0000000000003104.
PubMed 30741801
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Controlled Trial Comparing Dilation and Evacuation Outcomes With and Without Oxytocin Use
- ClinicalTrials.gov ID
- NCT02083809
- Acronym / sponsor ID
- OxyDE
- Conditions
- Abortion, Dilation and Evacuation, Hemorrhage, Blood Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Society of Family Planning, University of Washington
- Study start
- Oct 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Intravenous Fluids and Electrolytes500ml saline or lactated ringer without oxytocin added |
| Treatment group | Active comparator | Drug: intravenous oxytocinIntravenous oxytocin mixed with saline or lactated ringer |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Ultrasound findings suggestive of placenta accreta
- Patients requiring preoperative misoprostol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous oxytocin30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer) | Drug | Treatment group |
| Intravenous Fluids and Electrolytes500 ml of inert IV fluid | Drug | Placebo |
Primary outcome
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures.
Time frame: During surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30741801Whitehouse K, Tschann M, Soon R, Davis J, Micks E, Salcedo J, Savala M, Kaneshiro B. Effects of Prophylactic Oxytocin on Bleeding Outcomes in Women Undergoing Dilation and Evacuation: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):484-491. doi: 10.1097/AOG.0000000000003104.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous oxytocin and Intravenous Fluids and Electrolytes in people with Abortion and Dilation and Evacuation, run by University of Hawaii at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. (time frame: During surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.