Amniotomy for Second-trimester Pregnancy Termination

What Was Tested

This registered not phased trial tested Oxytocin.

The termination of abortion is an important issue that has many controversies.

The most common time of serious abortion-related complications is the second trimester.

Missed abortion is one of the most common indications of termination of pregnancy in the second trimester.

It had two arms (groups): Amniotomy group (other) and No-amniotomy group (other).

Amniotomy will be performed by toothed forceps. The handle of the device will be held with one hand outside the vagina while 2 fingers of the opposite hand will be placed in the vagina to guide the tip.

No-amniotomy will be done.

The registry classes the interventions as device, drug and procedure.

Who Took Part

The registry lists 60 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: Women aged 18-40 years old. Women who are pregnant in singleton mid-trimester missed abortion (18-26 weeks). Bishop's score is ≤ 4.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: women who delivered before by classic caesarian section or had a history of -myomectomy, hysteroscopic uterine surgery, or cervical surgery like conization; women with multiple gestations; women with ultrasonography evidence of low amniotic fluid volume.

How the Study Was Run

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

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.

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

It started in 2021-11-01 with completion listed for 2023-06-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The interval between induction to complete abortion (time frame: 15 hours).

What This Means in Plain Language

Put simply, this is a not phased, 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.