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

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

Clinical trial with control group and parallel groups, randomized and single blind, conducted on 111 patients

This study is performed on 111 pregnant women referring to Ommol Banin Hospital in Mashhad. Patients are divided into three groups. In the first group, the fetus is dislodged by pushing its head. In the second group, the fetus is dislodged through pulling its legs, and in the third group, the fetus is dislodged using the anterior shoulder technique. In this single blind study outcome assessors are unaware of the type of grouping.

Inclusion criteria; term pregnancy, fetal head is at station zero or higher, cessation of labor due to impacted fetal head. Exclusion criteria: patients for whom the fetus does not rotate in the first stage of dilation

In the intervention group, cesarean section is performed through the anterior shoulder technique. In the first control group, during the cesarean section, the fetus is dislodged through pushing the fetal head and in the second control group, the fetus is dislodged through pulling its legs.

Duration of surgery, bleeding volume during cesarean section, need for blood transfusion, length of hospital stay, apgar score of the newborn, the need to be hospitalized in neonatal intensive care unit (NICU)

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.

In this study only outcome assessors, when evaluating the patients, will be unaware of how patients are grouped and which treatment they receive.

All data can be shared after patients are made unidentifiable.

Data can be accessible 6 months after results are published.

Data will be available for researchers in universities and other scientific institutes.

Carrying out analysis on data is permitted.

Data can be accessible through an email to the corresponding author.

After sending a request email to the corresponding author, data will be sent in 1 month.