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IRCT20181123041731N2 IRCT 2019-06-26 Mashhad University of Medical Sciences Comparison of the effect of simultaneous administration of oxytocin with Foley catheter with co-administration of misoprostol and Foley catheter on cervical preparation and duration of labor Comparison of the effect of simultaneous administration of oxytocin with Foley catheter with co-administration of misoprostol and Foley catheter on cervical preparation and duration of labor in extended pregnancies. 2019-06-22 anticipated 74 Complete https://irct.ir/trial/39962 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is carried out using table of random numbers with the help of "www.randomization.com" website in which numbers are placed in sealed envelopes and once patients enter the study, envelopes are allocated to them placing them in one of the 2 groups. 2-3 extended pregnancies. Intervention 1: Intervention group: immediately after placing the Foley catheter, administration of oxytocin with dosage of 2 milliunits/min begins and 2 milliunits are added every 20 minutes up to reaching a maximum of 30 milliunits/min. After excretion of catheter in the active phase (dilation of 6 centimeters) and in case of the head being fixed, amniotomy is carried out. Intervention 2: Control group: After embedding the Foley catheter, sublingual misoprostol with dosage of 25 micro gram per every 4 hour up to a maximum of 6 dosages is prescribed. In this group, also, after excretion of catheter in the active phase (dilation of 6 centimeters) and in case of the head being fixed, amniotomy is carried out. 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 of equal to or greater than 40 weeks Cephalic presentation Absence of fetal anomaly Weight estimate of the fetus is less than 4500 grams Bishop Score of less than 4 Mother's age is greater than 18 Absence of parity of over 5 Absence of medical illnesses such as diabetes and high blood pressure 18 years no limit Female Placental abruption Chorioamnionitis Rupture of the membrane before the catheter is excreted Previous Cesarean section Gestational diabetes Placenta Previa and any type of contraindication for vaginal bleeding O66.9 Obstructed labor, unspecified Treatment - Drugs Treatment - Drugs Intervention group: immediately after placing the Foley catheter, administration of oxytocin with dosage of 2 milliunits/min begins and 2 milliunits are added every 20 minutes up to reaching a maximum of 30 milliunits/min. After excretion of catheter in the active phase (dilation of 6 centimeters) and in case of the head being fixed, amniotomy is carried out. Control group: After embedding the Foley catheter, sublingual misoprostol with dosage of 25 micro gram per every 4 hour up to a maximum of 6 dosages is prescribed. In this group, also, after excretion of catheter in the active phase (dilation of 6 centimeters) and in case of the head being fixed, amniotomy is carried out. Duration of reaching Bishop Score of 7 (the cervix is ready). Timepoint: 4 every 4 hours. Method of measurement: Internal examination. Duration of delivery. Timepoint: From admission to delivery. Method of measurement: Based on patient's file. Delivery method. Timepoint: At the time of delivery. Method of measurement: Based on the type of delivery which is recorded in the patient's file. Labor complications including tachysystole (more than 5 contractions in 10 minutes), bleeding after delivery. Timepoint: After delivery. Method of measurement: Clinical observation. Mashhad University of Medical Sciences Approved 2019-04-09 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)