Prevention of Primary Postpartum Haemorrhage

What Was Tested

The trial (phase 2) is built around Oxytocin.

Due to the high prevalence of anemia among pregnant women in low-resource settings, the outcome of PPH is often deteriorated, resulting in damaging health consequences 3.

It had two arms (groups): intrauterine misoprostol and oxytocin (experimental) and oxytocin (active comparator).

There will be added effect of misoprostol to stimulate uterine contraction along with oxytocin.

Only oxytocin will stimulate uterine contraction.

The registry classes the interventions as drug.

More on the Plan

All the collected data will be entered and analyzed by SPSS v. 21.

Mean and standard deviation will be calculated for quantitative variables like age, gestational age, BMI, pre and post Hb, and blood loss during caesarean section.

Frequencies along with percentages will be presented for qualitative variables like need of additional drugs, and side effects of misoprostol (fever, shivering, nausea, vomiting).

Paired sample t-test will be used to compare pre and post Hb levels of both groups.

Who Took Part

180 planned participants were the target.

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: 1\. All LSCS including emergency and elective 2. Full term pregnancy \>37 week.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: 1\. all vaginal deliveries 2. patients with bleeding or clotting disorders 3. maternal cardiac, renal, hepatic diseases 4. morbidly adherent placentas 5. preterm deliveries.

How the Study Was Run

The set-up was randomized, parallel-group and single-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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2021-02-03 with completion listed for 2021-08-30.

It ran at 1 site in Pakistan.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: measurement of haemoglobin level to assess the blood loss (time frame: six months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 180 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.