]>
IRCT20220403054399N1 IRCT 2022-04-24 Zanjan University of Medical Sciences The effect of transactional catheter and Extra-Amniotic Normal Saline Infusion (EASI) on cervical readiness Comparison of the effect of transactional catheter and Extra-Amniotic Normal Saline Infusion (EASI) on cervical readiness in primiparous mothers who are candidates for termination of pregnancy with Bishop score less than 4 4in Ayatollah Mosavi Hospital in Zanjan in 2021-2022 2022-05-10 anticipated 52 Complete https://irct.ir/trial/63083 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the block randomization method. The size of all blocks is equal. Random allocation software is also used to generate a random sequence of blocks, Blinding description: In this study, data collectors, outcome assessors, and manuscript writers will be completely unaware of the prescribing protocol. 3 labor. Intervention 1: Intervention group: In EASI patients, 15 cc of normal saline solution is first injected into the cervical catheter balloon and then this infusion is continued at a rate of one milliliter per minute into the extraamniotic space. Intervention 2: Intervention group: In the cervical traction catheter group, in the lithotomy position, the cervical catheter No. 24 passes directly throw the inner hole of the cervix and its balloon will be filled with 30 cc of sterile serum. Yes - There is a plan to make this available What will be shared: Part of the data including the main and secondary outcomes can be shared. When: Access period starts from 2023 To whom: Researchers working in academic and scientific institutions Conditions: Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals. Where to obtain: Contact the research expert of the Infertility Clinic of Zanjan University to receive the required documents or data. How to obtain: To submit a request, it is enough to contact the mentioned expert and send a written and signed request to her. Comments:
public Fatemeh Daraie
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
Zanjan Iran (Islamic Republic of) 1425678922 +98 21 8806 4148 Daraie.Fatemeh@zums.ac.ir Zanjan University of Medical Sciences scientific Fatemeh Daraie
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
zanjan Iran (Islamic Republic of) 1425678922 +98 21 8806 4148 Daraie.Fatemeh@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Single tone pregnancy Gestational age more than 37 weeks no limit no limit Female Premature rupture of membranes (PROM) previous cesarean section (CS) Placenta Previa Preeclampsia O60.2 Term delivery with preterm labor Treatment - Devices Treatment - Devices Intervention group: In EASI patients, 15 cc of normal saline solution is first injected into the cervical catheter balloon and then this infusion is continued at a rate of one milliliter per minute into the extraamniotic space. Intervention group: In the cervical traction catheter group, in the lithotomy position, the cervical catheter No. 24 passes directly throw the inner hole of the cervix and its balloon will be filled with 30 cc of sterile serum. Duration of first stage of labor. Timepoint: Not applicable. Method of measurement: hour. Duration of second stage of labor. Timepoint: Not applicable. Method of measurement: Hour. Zanjan University of Medical Sciences Approved 2022-02-21 Ethics committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Jomhori BLV. Azadi Squ. Zanjan Zanjan Zanjan Iran (Islamic Republic of)