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Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy

Plain-language guide to NCT06493968: not phased randomized trial of Oxytocin, 70 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06493968
Phase
not phased
Status
status unknown
Start
2024-07-01
Completion (planned or actual)
2024-12-31
Participants
70 (estimated)
Design
randomized, triple-blind, prevention
Conditions studied
Placenta Accreta Spectrum
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

It had two arms (groups): Group (A) (experimental) and Group (B) (placebo comparator).

Patients will be given uterotonics.

Patients will not be given uterotonics.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 70 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Pregnancy of singleton living fetus. Previous one or more cesarean sections. Gestational age: \> 32 weeks. The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity". Preoperative hemoglobin more than 10 gm/dl.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.…; any known or reported hypersensitivity to the used medication; all cases with spontaneous placental separation at laparotomy.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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, investigator and outcomes assessor.

It started in 2024-07-01 with completion listed for 2024-12-31.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Intraoperative blood loss (time frame: during operation).

It also tracked 1 secondary outcome, for example operative time.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 70 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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.