A comparative study of the effect of vaginal and pessary progesterone along with the vaginal progesterone in preventing preterm delivery in twin pregnancies of pregnant women

Comparison of the effect of vaginal progesterone and pessary on preventing preterm labor in twin pregnancies.

TThe primary ultrasound of pregnant women is performed by the research perinatologist to check and determine the length of the cervix. And it is referred to the associate perinatologist for the administration of progesterone and pessary implantation according to the study group. The main researcher examines the final outcome of pregnant women and finally the data analyst performs the data analysis without knowing the type of intervention. It should be noted that the pessary is removed by the main researcher or collaborator of the project during labor pains or gestational age over 37 weeks or cesarean section.

This is a double blind randomized clinical trial study which women pregnant with twins referred to Hazrat Rasool Akram Hospitals in 1403-1404 according to inclusion criteria will be included to the study. Women with a cervical length less than 25 mm will be randomly divided using a random number table into two groups.

In this study women pregnant with twins, with gestational age of 16-18 weeks and cervical length less than 25 mm will be enrolled to the study. Exclusion criteria will be included: Twin-Twin transfusion syndrome, monoamniotic twins, rupture of the membranes, the presence of a major or chromosomal abnormality in at least one fetus, women who have cervical cerclage in their current pregnancy, placenta previa

In intervention group, pregnant women will be treated with vaginal progesterone (cyclogest 200 mg/daily) and pessary and in n control will be only treated with vaginal progesterone (cyclogest 200 mg/daily).

The primary outcome of this study is gestational age at the delivery time.

In this study, with a sample size of 100 people, 50 balls for the vaginal progesterone intervention group and 50 balls for the vaginal and pessary progesterone group are placed in a lottery container, and then the balls are randomly removed from the container without replacement and the created sequence is recorded.

The primary ultrasound of pregnant women is performed by the research perinatologist to check and determine the length of the cervix. And it is referred to the associate perinatologist for the administration of progesterone and pessary implantation according to the study group. The main researcher examines the final outcome of pregnant women and finally the data analyst performs the data analysis without knowing the type of intervention. It should be noted that the pessary is removed by the main researcher or collaborator of the project during labor pains or gestational age over 37 weeks or cesarean section.