Induction of Labor in Pregnant Women With Prelabor Rupture of Membranes - Oxytocin or Misoprostol

What Was Tested

The trial (phase 4) is built around Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

Type of Study: Randomized controlled clinical trial.

Study procedures and interventions: 1.

History taking, examination and investigation will be done to choose eligible patients.

History: personal, obstetric history, past history (any medical or surgical disorder) Examination: General: pulse, blood pressure, temperature.

Who Took Part

The registry lists 200 actual participants took part.

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

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

Examples of who could join: Gestational age (36-42 weeks). Prelabor rupture of membranes within the last 24hours.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: history of medical diseases (htn, diabetes milletus, systemic lupus erythematosus, cardiac, etc.); antepartum hemorrhage; chorioamnionitis / prelabor rupture of membranes \>24hours.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2021-02-01 with completion listed for 2022-01-15.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: vaginal delivery (time frame: immediately after the intervention).

It also tracked 5 secondary outcomes, for example induction to active phase time, Induction to delivery time, Apgar score, NICU admission and maternal side effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 200 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.