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IRCT2014012616368N1 IRCT 2014-02-22 Qazvin University of Medical Sciences and Health Services cervical ripening and termination of term pregnancy Comparison the Effect of Isosorbide Mononitrate, Laminaria and Trans Cervical Catheter on cervical ripening and termination of term pregnancy 2013-09-23 anticipated 75 Complete https://irct.ir/trial/15333 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Delivery. Intervention 1: In first group, Isosorbide Mononitrate, 40 mg of this drug as Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The second and third doses, if Bishop is less than 4 per examination will be repeated every 4 hours. Administration of oxytocin immediately after preparation of the cervix (Bishop more than 4) or no response to procedures will be performed after 24 hours. Intervention 2: In the second group, a Foley catheter will be used. Catheter through the cervix will be inserted into the internal orifice of the cervix and balloon with 30 cc of air will be filled. Intervention 3: In third group, first, maternal vagina will be cleaned with Bethadine. After the speculum inserted, the anterior lip of the cervix will be taken with tenaculum and laminaria will be taken down depending on the size of the cervix so that its tip has been diced near the internal opening of the cervix.
public Maryam Iranipoor
Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard, Qazvin
Qazvin Iran (Islamic Republic of) +98 28 1223 7267 miranipoor@qums.ac.ir Qazvin University of Medical Sciences and Health Services scientific Farideh Movahed
Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard, Qazvin
Qazvin Iran (Islamic Republic of) 00 miranipoor@qums.ac.ir Qazvin University of Medical Sciences and Health Services Iran (Islamic Republic of) Inclusion criteria: Women with term pregnancy that are candidates for induction of labor; Bishop score is less than 4; Presentation of fetus is to be vertex; Nulliparous women.Exclusion criteria: Having a spontaneous contraction; Rupture of membranes; Placenta previa. 15 years 35 years Female O00-O99 Pregnancy, childbirth and the puerperium Treatment - Drugs Treatment - Devices Treatment - Devices In first group, Isosorbide Mononitrate, 40 mg of this drug as Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The second and third doses, if Bishop is less than 4 per examination will be repeated every 4 hours. Administration of oxytocin immediately after preparation of the cervix (Bishop more than 4) or no response to procedures will be performed after 24 hours. In the second group, a Foley catheter will be used. Catheter through the cervix will be inserted into the internal orifice of the cervix and balloon with 30 cc of air will be filled. In third group, first, maternal vagina will be cleaned with Bethadine. After the speculum inserted, the anterior lip of the cervix will be taken with tenaculum and laminaria will be taken down depending on the size of the cervix so that its tip has been diced near the internal opening of the cervix. Cervical ripening. Timepoint: During at the study (every 4 hours). Method of measurement: Examination of the vagina. Duration of the third stage of labor (from complete expulsion of fetus to the exit of placenta). Timepoint: During at the study. Method of measurement: Observation and examination. Method of Delivery. Timepoint: During at the study. Method of measurement: Observation and examination. Maternal complications (Over stimulation of the uterus, postpartum hemorrhage, genital tract lacerations, headaches, nausea, vomiting, and dizziness). Timepoint: During at the study. Method of measurement: Observation and examination. Duration of first stage of labor (including latent and active phases). Timepoint: During at the study. Method of measurement: Observation and examination. Duration of the second stage of labor (from full dilatation to expulsion of fetus). Timepoint: During at the study. Method of measurement: Observation and examination. Neonatal outcomes (Apgar score at first and fifth minutes, sex and birth weight, hospitalization of neonate in the Neonatal Intesive Care Uinte) will be measured. Timepoint: During at the study. Method of measurement: Observation and examination. Qazvin University of Medical Sciences and Health Services Approved 2013-09-04 Qazvin University of Medical Sciences and Health Services Medicine School, Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard Qazvin Iran (Islamic Republic of)