]>
IRCT20181123041731N1 IRCT 2019-01-27 Mashhad University of Medical Sciences Investigation of the effect of misoprostol in comparison with misoprostol with Foley catheter on cervical ripening for labor induction of in women with preterm premature rupture of the membrane Investigation of the effect of misoprostol alone in comparison with misoprostol with Foley catheter on cervical ripening for labor induction in women with preterm premature rupture of the membrane 2017-08-01 anticipated 200 Complete https://irct.ir/trial/35515 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment is based on the random list generated by a computer. At first, two series with equal numbers of green and blue cards are prepared and placed into envelopes which are numbered according to the random list. Afterwards, the midwife assigns an envelope to each patient based on the numerical order. N/A Preterm premature rupture of the membranes. Intervention 1: Control group: Labor induction with 25 μg sublingual misoprostol is carried out every 4 hours for patients after hospitalization. Misoprostol is prescribed up to 4 doses in case of need. Intervention 2: Intervention group:Labor induction with 25 μg sublingual misoprostol is carried out every 4 hours with insertion of foley catheter size 18 and filling the balloon with 80 cc of normal saline, which is placed in dorsal lithotomy position in sterile conditions. In addition, light stretching is performed in order to examine the catheter exit. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Malihe Rakhshani far
Ghaem hospital, Ahmad Abad Ave
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2477 rakhshanifm951@mums.ac.ir Mashhad University of Medical Sciences scientific Masoumeh Mirteimouri
Ommol-Banin hospital, Azadi 16th, Azadi Avenue
Mashhad Iran (Islamic Republic of) 9144663595 +98 51 3223 1444 mirteimourim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Alive singleton pregnancy Gestational age is greater than or equal to 36 weeks Cephalic presentation Bishop Score is less than 4 no limit no limit Female Symptoms of chorioamnionitis in mother or fetus at the onset of hospitalization Gestational Diabetes Fetal distress Previous cesarean section and any contraindication for vaginal delivery Time of membrane rupture exceeds 12 hours Active labor phase O42 Premature rupture of membranes Treatment - Drugs Treatment - Drugs Control group: Labor induction with 25 μg sublingual misoprostol is carried out every 4 hours for patients after hospitalization. Misoprostol is prescribed up to 4 doses in case of need. Intervention group:Labor induction with 25 μg sublingual misoprostol is carried out every 4 hours with insertion of foley catheter size 18 and filling the balloon with 80 cc of normal saline, which is placed in dorsal lithotomy position in sterile conditions. In addition, light stretching is performed in order to examine the catheter exit. Time interval between the onset of induction and delivery. Timepoint: after intervention. Method of measurement: Patient's file. Mashhad University of Medical Sciences Approved 2016-12-29 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)