Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?

What Was Tested

The trial (not phased) is built around Oxytocin.

Oxytocin traditionally has been used for induction and augmentation of labour however prolonged labour continued to occur with attendant sequelae.

It had two arms (groups): PROPRANOLOL GROUP (active comparator) and OXYTOCIN ONLY GROUP (placebo comparator).

Participants had outright augmentation or induction of labor with oxytocin only.

The registry classes the interventions as drug.

More on the Plan

There was daily recruitment of participants.

Randomization was by utilizing computer-generated numbers from a pool of 110 participants divided into A and B.

Group B received only oxytocin titration.

Partograph was used to monitor their labour.

Who Took Part

Enrollment: 110 actual participants took part.

It was open to women only aged from 16 years up to 45 years.

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

Examples of who could join: Nulliparous women selected for induction or augmentation of labour. Term pregnancy selected for induction or augmentation of labour. Normal singleton pregnancies with cephalic presenting foetuses. Those who gave their consent.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: co-existing medical illnesses such as diabetes mellitus, cardiac disease, haemoglobinopathies, renal diseases, hypertensive disease, bronchial asthma,; women currently taking propranolol or a chronic beta-blocker use; contraindications to labour or vaginal delivery.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Being open-label, the Oxytocin study did not mask who received what.

It started in 2020-11-02 with completion listed for 2021-04-30.

It ran at 1 site in Nigeria.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Induction/Augmentation delivery intervals at delivery (time frame: Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta).

It also tracked 2 secondary outcomes, for example Maternal Blood pressure change in mmgh and Fetal heart rate change in seconds.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 110 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.