Evaluation of the effect of Epidural anesthesia beginning time on Labor progression and conversion of Vaginal delivery to Cesarean Section

Determining the effect of epidural anesthesia beginning time on labor progression Determining the effect of epidural anesthesia beginning time on Cesarean section rate

In this study, 426 eligible women who have been admitted to the maternity ward at Arash Hospital will be selected. Participants will be randomly divided into two groups and a special code will be assigned to each participant.

This study is a randomized single blind parallel clinical trial that will be conducted in Arash Women's Hospital. Written consent will be obtained from eligible patients and after completing a demographic questionnaire, they will be examined by anesthesiologist. After anesthesiologist's permission, the participants will be randomly divided into two groups. Group 1: Includes 213 people, When the cervical dilatation reached 3 cm epidural anesthesia will be done with injecting 15 cc of bupivacaine 0.00125% plus fentanyl 50 micrograms into epidural space by an epidural catheter of size 17. Then the needle will be removed and the catheter remains in place and fixed by the adhesive to the patient's back. Every hour, with the onset of pain, we will inject the half volume of the solution through the catheter until the delivery. Group 2: Includes 213 people, When the cervical dilatation reached 5 cm will receive epidural anesthesia as described for first group. Epidural anesthesia in both group will be conducted by a same anesthesiologist.

All women aged 18-40 years old, in their first pregnancy that don't have any complication during pregnancy and don't have any medical or surgical contraindication for epidural anesthesia will be included in the trial after Giving written consent

Group 1:early onset of epidural anesthesia at 3 cm cervical dilatation Group 1:early onset of epidural anesthesia at 5 cm cervical dilatation

The primary outcome: Progression of delivery in two groups according to the partograph chart (labor time to delivery) the length of the active stage of labor (dilation of 5 to 10 cm) and the length of the second stage. Secondary outcomes: Neonatal Apgar score, determined in accordance with the Apgar table Comparison of delivery type in two groups (vaginal to cesarean delivery)

Our sample size is 426 people, with 213 people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. The number of blocks considered is 6.

The random allocation list for patients is solely available to the epidemiologist. To hide the random allocation process, 426 sequences of treatments will be written accordingly, and then the cards will be placed in sealed envelopes. On each 10-digit random code packet, the order is written and the framework is written that the patient identification number is relevant and the methodologist will simply be aware of the design of the code. When an anesthesiologist announces the eligibility of a patient, the methodologist will provide the anesthesiologist with the envelope. The analgesia method is selected based on the type mentioned in the envelope. None of the patients should be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is the third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used.

Because we have plan to use our data in another studies, we are not interested to sharing the data at this time