Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and PL1 (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Methodology All term-pregnant, nulliparous women presenting to the delivery ward are potential study patients unless they have already been enrolled in another clinical study.

Subjects may be pre-informed about the study through the use of advertisements or information at the physician/midwife visits during pregnancy and at hospital admission.

The whole study includes the following steps: * Screening and Baseline including informed consent and randomization * Labor * Discharge * Follow-up at 8 (+/-1)weeks - End of study * Safety follow up of infant at 6 months, +/-4 weeks, by telephone interview.

Who Took Part

The registry lists 361 actual participants took part.

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

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

Examples of who could join: Pregnant women of ≥18 to ≤45 years of age. Gestational age \> 36 weeks + 6 days confirmed by ultrasound. Experience slow progress of labor including prolonged latent phase and labor arrest (according to the respective definitions) etc.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: subjects with secondary slow progress or secondary labor arrest; BMI≥35 during first trimester of pregnancy; breech presentation or other abnormal presentations etc.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

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, investigator and outcomes assessor.

It started in 2016-12 with completion listed for 2018-11.

It ran at 12 sites in Sweden (8), Finland (3) and Denmark (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time from start of infusion of tafoxiparin/placebo until vaginal partus (time frame: Interval from start of study drug administration to vaginal delivery (hours, up to 36 hours )).

It also tracked 13 secondary outcomes, for example Safety will be evaluated through rate and frequency of adverse events and serious adverse events, Time from cervical dilatation of 4 cm and progress of labor until vaginal partus, Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours from start of study drug infusion to vaginal partus, Proportion of women with caesarean sections, Proportion of women undergoing instrumental deliveries and Use of analgesia (N2O, epidural, pudendal nerve block).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 361 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.