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IRCT20201024049128N2 IRCT 2020-12-19 Karaj University of Medical Sciences Comparison of probiotics in the prevention of preterm labor Comparison of vaginal and oral probiotics in the prevention of preterm labor 2020-12-21 anticipated 185 Complete https://irct.ir/trial/53003 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization list will be prepared by the statistician (using the site: www. scale develope.com). Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained, Blinding description: Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. Due to the type of intervention, participants will aware of the type of treatment. 3 Preterm labor. Intervention 1: Intervention group: Oral probiotic pills once a day for up to 37 weeks of pregnancy. Intervention 2: Intervention group: Probiotic vaginal capsule once a day for up to 37 weeks of pregnancy. Intervention 3: Control group: No intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Bita badehnoosh
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3222 2021 b_badehnoosh@yahoo.com Karaj University of Medical Sciences scientific Bita badehnoosh
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3222 2021 b_badehnoosh@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Intact amniotic membrane No taking probiotics No maternal disease including pyelonephritis, preeclampsia, chronic hypertension, diabetes. Gestational age greater than or equal to 25 weeks Normal cervical length no limit no limit Female The mother's unwillingness to be in this study Cervical length less than 3 cm Existence of labor show Effective labor pains Oligohydramnios polyhydramnios placental abruption placenta previa hepatic impairment Existence of abnormal fetal heart rate pattern in monitoring Intrauterine infection O60 Preterm labor Prevention Prevention N/A Intervention group: Oral probiotic pills once a day for up to 37 weeks of pregnancy Intervention group: Probiotic vaginal capsule once a day for up to 37 weeks of pregnancy Control group: No intervention Preterm labor. Timepoint: Delivery before 37 weeks. Method of measurement: Medical record. Kind of delivery. Timepoint: After labor. Method of measurement: Medical record. NICU administration. Timepoint: After birth. Method of measurement: Medical record. Karaj University of Medical Sciences Approved 2020-12-12 Ethics committee of Alborz University of Medical Sciences Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street Karaj Alborz Iran (Islamic Republic of)