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IRCT20101227005485N8 IRCT 2020-04-27 Tabriz University of Medical Sciences Comparison of the effect of misoprostol with oxytocin in companion with a cervical catheter in the induction of labor: a clinical trial Comparison of the effect of misoprostol and cervical catheter with oxytocin and cervical catheter in the induction of labor: a clinical trial 2020-04-20 anticipated 50 Complete https://irct.ir/trial/44907 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The placement in each intervention or control group will be done by the sealed envelopes containing the type of intervention and the envelopes will be removed and opened consecutively, and the type of treatment will be based on its content. This will be done in such a way that the outcome assessor and the data analyzer will not know the intervention type. 3 labor induction. Intervention 1: Control group:Following the insertion of the Foley catheter No.16 inside the uterus and filling its bag with 30 cc of serum saline, 25 micro-gram of misoprostol tablet will be given sub-lingually and repeated every 6 hours for up to 4 doses in the absence of effective labor contractions. If spontaneous contractions occur for at least 3 contractions of 45-60 seconds within 10 minutes, the next dose will not be given. Upon dilatation of 3–4 cm, if no contraction occurs, induction will begin with high dose oxytocin (4 mili-unit per minute every 15-20 minutes will be done and this will be continued until at least 3-4 contractions of 45-60 seconds occur every 10 minutes) method. Intervention 2: Intervention group: Following the insertion of the Foley catheter No.16 inside the uterus and filling its bag with 30 cc of serum saline, induction with high dose method, 4 mili-unit per minute of oxytocin and increment of 4 mili-unit per minute every 15-20 minutes will be done and this will be continued until at least 3-4 contractions of 45-60 seconds occur every 10 minutes. 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 may not be used properly.
public Nazli Navali
Alzahra hospital, Artesh street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3554 1221 navalin@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Nazli Navali
Artesh street, Alzahra Hospital
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3554 1221 navalin@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Pregnancy age of 37 weeks and over indication for termination of pregnancy primiparous women singleton pregnancy reassuring fetal heart rate cephalic presentation intact fetal membranes ineffective labor contractions Bishop Score 6 or below no limit no limit Female Misoprostol allergy fever over 38 °C history of uterine surgery and cesarean obstetric indication for cesarean delivery anemia and blood dyscrasia asthma Treatment - Drugs Treatment - Drugs Control group:Following the insertion of the Foley catheter No.16 inside the uterus and filling its bag with 30 cc of serum saline, 25 micro-gram of misoprostol tablet will be given sub-lingually and repeated every 6 hours for up to 4 doses in the absence of effective labor contractions. If spontaneous contractions occur for at least 3 contractions of 45-60 seconds within 10 minutes, the next dose will not be given. Upon dilatation of 3–4 cm, if no contraction occurs, induction will begin with high dose oxytocin (4 mili-unit per minute every 15-20 minutes will be done and this will be continued until at least 3-4 contractions of 45-60 seconds occur every 10 minutes) method. Intervention group: Following the insertion of the Foley catheter No.16 inside the uterus and filling its bag with 30 cc of serum saline, induction with high dose method, 4 mili-unit per minute of oxytocin and increment of 4 mili-unit per minute every 15-20 minutes will be done and this will be continued until at least 3-4 contractions of 45-60 seconds occur every 10 minutes. The time to ripen the cervix. Timepoint: every two hours. Method of measurement: vaginal examination. Duration of latent phase of labor. Timepoint: every two hours. Method of measurement: vaginal examination. Duration of active phase of labor. Timepoint: every hour. Method of measurement: vaginal examination. Duration of second stage of labor. Timepoint: every half hour. Method of measurement: vaginal examination. Complication rate. Timepoint: Continuous during labor. Method of measurement: fetal monitoring. Tabriz University of Medical Sciences Approved 2019-12-24 Ethics Committee of Tabriz University of Medical Research Deputy of Tabriz University of Medical Sciences, University of Tabriz, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)