The effect of sildenafil citrate on fetal distress during labor and cesarean section - a double-blind clinical trial with placebo

Determining the effect and effectiveness of sildenafil citrate on fetal distress and the rate of cesarean section

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 104 patients. The online system was used for randomization. https://www.sealedenvelope.com/simple-randomiser/v1/lists

Pregnant mothers referred to Al-Zahra Hospital in Rasht divided into two groups of control and case, they are divided into equal numbers and randomly after entering the study, a test package is given to each participant in order numbered in order. The first dose of sildenafil or placebo is given when the participant enters the labor department for delivery. Sildenafil is given orally 50 mg every 6 hours for a maximum of 3 doses. The placebo is given to the control group according to the instructions.

Subjects include pregnant women referring to Alzahra Hospital in Rasht for normal delivery. Inclusion conditions: aged between 18-40 years, with singleton pregnancy (37-41 weeks), has a normal fetal structure, with cephalic presentation without any anomalies, estimated weight above 2500 grams or without CPD, who are candidate for normal vaginal delivery included in this survey. Exclusion criteria: drug reaction to Sildenafil, fetal anomalies, metabolic disorder, cardiac disorders, visual disorders, renal disorders, liver anomalies, previous cesarean, preeclampsia, HTN, Alcohol, Taking medications Nitrate, α-blocker.

Intervention group: A group of 104 people who receive a package containing three capsules sildenafil 50 mg with instructions for clinical staff. Control group : A group of 104 people who receive a package containing three placebo capsules.

Need for cesarean section

208 pregnant mothers referred to Al-Zahra Hospital in Rasht are randomly divided into 2 groups of 104 (intervention and control). Group 1 (intervention) is called A and group 2 (control) is called B. Random blocking will be done in such a way that numbers are assigned to the research units in order. Then there is a table with 47 rows called blocks and each block will have 4 parts and each part is named A and B, will be considered. In the next step, the numbers are placed in each house in order. After all the numbers are placed in the blocks, People who had a number in house A, Package with code A and people who had a number in house B, They will receive a package with code B. Concealment is done using the sealed envelope method. An online randomization service was used to generate the list. https://www.sealedenvelope.com/simple-randomiser/v1/lists

The treatment group of each patient(The intervention group receiving sildenafil capsules and the control group receiving placebo capsules) will be determined only after randomization. This project will be carried out by a group of medical experts and all people will be blind (participants, Principal investigator, Health care personnel who are responsible for taking care of patients, Responsible for data collection, those who evaluate the outcome), Except for one specialist doctor who is independent from the research team, who prescribes the assigned codes for each of the pregnant mothers who refer to Al-Zahra Rasht Hospital. Also, each group of patients (intervention and control) will be treated in a separate place and are not related to each other.

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