Blood Loss During Cesarean Delivery in Placenta Previa Patients

What Was Tested

This registered phase 4 trial tested Oxytocin.

It had three arms (groups): Tranexamic acid group (active comparator), Misoprostol group (active comparator) and Oxytocin only (control) group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Placenta previa is defined as complete or partial covering of the internal os of the cervix with the placenta, at more than 16 weeks of gestation.

Placenta previa is a major risk factor for postpartum hemorrhage (PPH) and can lead to maternal and neonatal morbidity and mortality.

Regardless of the mode of administration, oxytocin use in the setting of CD may result in maternal adverse effects, such as hypotension and tachycardia.

Misoprostol, a prostaglandin E1 analogue with strong uterotonic properties binds to myometrial cells to cause strong myometrial contractions.

Who Took Part

The registry lists 81 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Parity: primigravida or multigravida. Gestational age: ≥ 36 weeks (confirmed by the first day of the last menstrual period or first trimester ultrasound scan). Candidate for termination of pregnancy by cesarean delivery. Singleton living healthy normally growing fetus. Cesarean delivery under spinal anesthesia.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: patients diagnosed with morbidly adherent placenta; placenta previa cases requiring cesarean hysterectomy in the primary surgery; patients with preoperative anemia (hemoglobin \<9 gm/dl).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-05-04 with completion listed for 2022-12-15.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): To compare the estimated blood loss during cesarean delivery among the three groups (time frame: less than 2 hours).

It also tracked 5 secondary outcomes, for example The Use of additional ecbolics denoting uterine atony and The need for blood transfusion.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 81 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.