Rectal Misoprostol for Reducing Blood Loss in Elective Cesarean Section

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

The study will compare outcomes between two groups: women receiving oxytocin alone and women receiving oxytocin plus rectal misoprostol.

It had two arms (groups): Control: Oxytocin only (experimental) and Intervention: Oxytocin + Rectal Misoprostol (experimental).

Description: Participants receive standard intraoperative uterotonic therapy with oxytocin according to hospital protocol immediately after delivery of the baby and placenta. Standard perioperative care (spinal anesthesia, prophylactic antibiotics, fluid management, monitoring) is provided. Rescue uterotonic measures and transfusion given as clinically indicated.

The registry classes the interventions as drug.

More on the Plan

The rectal route is particularly advantageous, providing rapid absorption, sustained uterine contraction, and fewer gastrointestinal side effects.

However, its onset of action is slower than oxytocin, which may affect intraoperative hemostasis if uterine tone is not achieved quickly.

Eligible participants will be women aged 18-45 years with singleton pregnancies at ≥37 weeks of gestation undergoing elective cesarean section.

Participants will be randomized into two groups: Group A (Control): Oxytocin only, given according to hospital protocol immediately after delivery of the baby and placenta.

Who Took Part

The registry lists 282 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women aged 18-45 years. Singleton pregnancy at ≥37 weeks of gestation. Elective cesarean section planned under spinal anesthesia. Hemodynamically stable prior to surgery. Provided written informed consent.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: multiple pregnancy; antepartum hemorrhage (e.g., placenta previa, abruption); coagulopathy, thrombocytopenia, or anticoagulant therapy.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2025-10-01 with completion listed for 2026-10-31.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Intraoperative and postoperative blood loss (time frame: From skin incision until 24 hours after cesarean delivery).

It also tracked 1 secondary outcome, for example Change in Hemoglobin and Hematocrit.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 282 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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