IRCT138706051096N1 IRCT 2009-02-20 Vice Chancellor for research-Guilan University of Medical Sciences Evaluation of the effect of vaginal Progesterone in preventing preterm labor Evaluation of the effect of vaginal Progesterone in preventing preterm labor 2009-01-22 anticipated 260 Complete https://irct.ir/trial/116 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 prevention of preterm labor. Intervention 1: Intervention group: Progesterone vaginal supp (200 mg); after two hours, the subject was examined for cessation of labor pain. If no contraction was detected she was given a vaginal supp per day. Intervention 2: Control group: Placebo vaginal supp (200 mg); after two hours, the subject was examined for cessation of labor pain. If no contraction was detected she was given a vaginal supp per day.

public Dr. Seyede Hajar Sharami

Reproduction Health research center-Alzahra hospital-Namjo street

Rasht Iran (Islamic Republic of) +98 13 1322 5624 Sharami@gums.ac.ir Guilan University of Medical Sciences scientific Dr.Seyede Hajar Sharami

Reproduction Health research center-Alzahra hospital-Namjo street

Rasht Iran (Islamic Republic of) +98 13 1322 5624 Sharami@gums.ac.ir Giulan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Pregnant women were eligible to enter the trial if 1) they were between 26-36 weeks of gestation based on their LMP or sonography before 16 weeks of gestation. 2) Confirmation of premature delivery with a)uterine contractions more than 30 seconds and three or more contractions per 30 minutes established by tochodynamometer b) cervical dilatation of 0-2 cm in nulliparous and 1 -2 cm in multiparous and cervical effacement greater than 50% 3) intact membrane. Exclusion criteria included: 1) unwillingness or inability to comply with study procedures before 36 weeks of gestation 2) lack of useful sufficient data 3) preeclampsia requiring termination of pregnancy. 15 years 50 years Female O60 Preterm labour Intervention group: Progesterone vaginal supp (200 mg); after two hours, the subject was examined for cessation of labor pain. If no contraction was detected she was given a vaginal supp per day. Control group: Placebo vaginal supp (200 mg); after two hours, the subject was examined for cessation of labor pain. If no contraction was detected she was given a vaginal supp per day. Prevention of preterm labour( before 37 weeks). Timepoint: 2 hours after insertion of suppository, then weekly visit. Method of measurement: control of uterine contraction. Prevention of preterm labor (before 34 weeks). Timepoint: every two weeks. Method of measurement: Patient visits, uterine contraction determination. Delay of delivery. Timepoint: post partum. Method of measurement: documented data. Duration of hospitalization. Timepoint: post partum (weekly). Method of measurement: documented data. Mean of frequancy,intensity and duration of contractions. Timepoint: 48 hours after initiation of therapy. Method of measurement: detected by Tochodynamometer. Delay of delivery. Timepoint: postpartum. Method of measurement: documented data. Delay for a week of delivery. Timepoint: after delivery. Method of measurement: documented data. Low birth weight. Timepoint: after delivery. Method of measurement: documented data. APGAR score below 7. Timepoint: after delivery. Method of measurement: documented data. NICU admission. Timepoint: after delivery. Method of measurement: documented data. Perinatal Mortality. Timepoint: after delivery. Method of measurement: documented data. Fetal death. Timepoint: after delivery. Method of measurement: documented data. Neonatal distress. Timepoint: after delivery. Method of measurement: documented data. Postpartum Retinopathy. Timepoint: after delivery. Method of measurement: documented data. Necrotizing entrocolitis. Timepoint: after delivery. Method of measurement: documented data. Neonatal sepsis. Timepoint: after delivery. Method of measurement: documented data. Intraventicular hemorrhage. Timepoint: after delivery. Method of measurement: documented data. Side effects of progesteron. Timepoint: every two weeks. Method of measurement: interview. Premature rupture of membranes. Timepoint: during delivery. Method of measurement: documented data. Chorioamnionitis. Timepoint: after delivery. Method of measurement: documented data. Severe hemorrhage (blood transfusion). Timepoint: after delivery. Method of measurement: documented data. Days of hospitalization. Timepoint: after delivery. Method of measurement: documented data. Vice Chancellor for research-Guilan University of Medical Sciences Approved Vice chancellor for research-Guilan University of Medical Sciences Vice chancellor for research-Guilan University of Medical Sciences-opposite of Azodi Studium-Namjo street Rasht Iran (Islamic Republic of)