Medical Management of Late Intrauterine Death.

What Was Tested

The trial (phase 4) is built around Oxytocin.

It had two arms (groups): isosorbide dinitrate-oxytocin (experimental) and misoprostol-oxytocin (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The main result of the study was the success rate of foetal expulsion within 15 hours, while the average administration induction interval defined the secondary result.

A total of 60 women with pregnancies greater than 20 weeks gestation were referred for foetal evacuation.

The approval to conduct the study was obtained from the institutional board ethical committees of both hospitals.

All participants were informed about the objectives of the study, and informed consent was required.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to women only.

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

Examples of who could join: Closed cervix without evidence of cervical dilation or baseline uterine activity. A Bishop score of \<5, having intact membranes. Gestation greater than or equal to 20 weeks established by the date of menstruation or by fetometry and ultrasound-confirmed late IUFD.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: multiple pregnancies; patients with a history of hypertension; women with a history of unexplained antepartum haemorrhage, pelvic dystocia or any another counter-indications where medications were used.

How the Study Was Run

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

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2008-05 with completion listed for 2013-09.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Rates of uterine expulsion in the women who received the isosorbide dinitrate-oxytocin regimen (time frame: within 15 hours of administration).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 60 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.