Oxytocin and Abdominal MyomectomyPhase 3NCT03702946

Oxytocin Infusion and Abdominal Myomectomy

A Phase 3 study testing oxytocin in abdominal myomectomy in people with Oxytocin and Abdominal Myomectomy, run by Armed Forces Hospital, Pakistan at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Objective:To compare oxytocin infusion with control, in patients undergoing abdominal myomectomy in terms of mean blood loss. Design: Single blinded randomized control trial Setting: Obstetrics and Gynecology Department, Military Hospital, Rawalpindi Population: 60 women of ASA class I-II, with intramural fibroids… Read more about this study

Who is it for?: Ages 25 to 40 years, women only
Conditions the study is for: Oxytocin and Abdominal Myomectomy
What is being tested?: oxytocin in abdominal myomectomy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesPakistan
Study dates: 15 Jul 2017to 15 Jan 2018
Phase: Phase 3
Are there results?: None posted in the registry

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 25 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

women of ASA class I-II with intramural fibroids,
women planned to undergo elective abdominal myomectomy

Who cannot join

Women with hemoglobin (Hb) < 10g/dl
Women with any respiratory or cardiovascular disease.

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

Department of Pediatrics
Rawalpindi, Punjab Province, 68000
Military Hospital
Rawalpindi, Punjab Province, 68000

Other trials in Pakistan

About this study

Official title: Effect of Oxytocin Infusion on Reducing the Blood Loss During Abdominal Myomectomy: A Randomized Controlled Trial

Objective:To compare oxytocin infusion with control, in patients undergoing abdominal myomectomy in terms of mean blood loss.

Design: Single blinded randomized control trial Setting: Obstetrics and Gynecology Department, Military Hospital, Rawalpindi Population: 60 women of ASA class I-II, with intramural fibroids, candidate for elective abdominal myomectomy.

Methods: Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given.

Main outcome measure: Intra-operative blood loss

Conditions: Oxytocin and Abdominal Myomectomy
Being tested: oxytocin in abdominal myomectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oxytocin in abdominal myomectomyOther
Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given

Study groups in NCT03702946
Study group	Role	What they receive
study group	Experimental	Not described Receives: Other: oxytocin in abdominal myomectomy
control group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Intra-operative blood loss
average intra operative blood loss was measured
Measured: during the surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201715 Jan 2018

First posted11 Oct 2018
Study start15 Jul 2017
Primary completion15 Jan 2018
Study completion15 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Oxytocin and Abdominal MyomectomyStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03702946
Sponsor's protocol ID: OXYTOCIN
Status last verified: Oct 2018
First submitted: 6 Oct 2018
Last updated: 11 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Oxytocin Infusion on Reducing the Blood Loss During Abdominal Myomectomy: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03702946
Acronym / sponsor ID: OXYTOCIN
Conditions: Oxytocin and Abdominal Myomectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Armed Forces Hospital, PakistanUniversity, hospital or other
Study start: 15 Jul 2017 (actual)
Primary completion: 15 Jan 2018 (actual)
Study completion: 15 Jan 2018 (actual)
First posted: 11 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Objective:To compare oxytocin infusion with control, in patients undergoing abdominal myomectomy in terms of mean blood loss.

Main outcome measure: Intra-operative blood loss

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
study group	Experimental	Other: oxytocin in abdominal myomectomy
control group	No intervention	–

Who may qualify

Ages: 25 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

women of ASA class I-II with intramural fibroids,
women planned to undergo elective abdominal myomectomy

Key exclusion criteria (2 listed)

Women with hemoglobin (Hb) < 10g/dl
Women with any respiratory or cardiovascular disease.

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
oxytocin in abdominal myomectomyWomen were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given	Other	study group

Primary outcome

Intra-operative blood loss
Time frame: during the surgical procedure
average intra operative blood loss was measured

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Individual participant dataSharing planned: No

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 Phase 3 study testing oxytocin in abdominal myomectomy in people with Oxytocin and Abdominal Myomectomy, run by Armed Forces Hospital, Pakistan at 2 sites in Pakistan.

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 2 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 11 Oct 2018. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Intra-operative blood loss (time frame: during the 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 NCT03702946.

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 11 Oct 2018.