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IRCT20201006048949N2 IRCT 2022-01-01 Mashhad University of Medical Sciences Comparison of maternal and neonatal fate of fetal cesarean method Comparison of maternal and neonatal outcome in three techniques: cephalic, breech and anterior shoulder used to deliver a deeply impacted fetal head during cesarean section 2021-10-16 anticipated 111 Complete https://irct.ir/trial/51605 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: The envelopes will be prepared by one of the members of the research team and the random numbers generated by the ''www.randomization.com'' website will be printed and placed in each envelope. In this website, the number of participants along with the number of groups are entered. Then for each group, a number of codes will be generated randomly. The envelopes are sealed and their contents are not visible from outside. At first, purpose of the study is explained for each participants and after filling out the consent form, each participant selects an envelope and opens it and based on its content, the participant will be placed in either the intervention or one of the control groups, Blinding description: In this study only outcome assessors, when evaluating the patients, will be unaware of how patients are grouped and which treatment they receive. N/A Fetal cesarean section. Intervention 1: Control group: In this group during cesarean section, the fetal head faces down towards the mother's vagina. Using the push technique, the fetal head is dislodged by pushing it through the vagina. Intervention 2: Control group: In this group during cesarean section, the fetal buttocks are closer to the birth canal and the fetal head is up. Using the pulling technique, the fetus is dislodged by pulling its legs. Intervention 3: Intervention group: In this group during cesarean section, the anterior shoulder technique is used to deliver a deeply impacted fetal head. In this technique, at first, the fetal shoulder and body and then, the fetal head are dislodged. 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 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 Farideh Akhlaghi
Zarrineh Crossroads - Ayatollah Behjat Street
Mashhad Iran (Islamic Republic of) 9144734756 +98 51 3223 1061 Akhlaghif@mums.ac.ir Mashhad University of Medical Sciences scientific Farideh Akhlaghi
Zarrineh Crossroads - Ayatollah Behjat Street
Mashhad Iran (Islamic Republic of) 9144734756 +98 51 3223 1061 Akhlaghif@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Term pregnancy Fetal head is at station zero or higher Cessation of labor due to impacted fetal head no limit no limit Female Patients for whom the fetus does not rotate in the first stage of dilation. O63.1 Prolonged second stage (of labor) Treatment - Surgery Treatment - Surgery Treatment - Surgery Control group: In this group during cesarean section, the fetal head faces down towards the mother's vagina. Using the push technique, the fetal head is dislodged by pushing it through the vagina. Control group: In this group during cesarean section, the fetal buttocks are closer to the birth canal and the fetal head is up. Using the pulling technique, the fetus is dislodged by pulling its legs. Intervention group: In this group during cesarean section, the anterior shoulder technique is used to deliver a deeply impacted fetal head. In this technique, at first, the fetal shoulder and body and then, the fetal head are dislodged. Duration of surgery. Timepoint: During childbirth. Method of measurement: Observation and examination. Bleeding volume during cesarean section. Timepoint: During labor and up to 24 hours after labor. Method of measurement: Based on a checklist which includes counting the number of gauzes and long gauzes during cesarean section and hemoglobin level 24 hours after delivery. Need for blood transfusion. Timepoint: During surgery. Method of measurement: Counting the number of gauzes which have absorbed blood and the amount of blood inside the suction. Length of hospital stay. Timepoint: From admission to discharge. Method of measurement: Number of days of hospital stay. Apgar score of the newborn. Timepoint: Minute 1 and 5 after birth. Method of measurement: Examination. The need to be hospitalized in neonatal intensive care unit (NICU). Timepoint: After childbirth. Method of measurement: Based on Apgar score. Need for hysterectomy or urinary tract surgery. Timepoint: Examination during childbirth. Method of measurement: observation. Mashhad University of Medical Sciences Approved 2020-07-15 Ethics Committee of Mashhad University of Medical Sciences Mashhad, University St., Mashhad University of Medical Sciences, Vice Chancellor for Research, Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)