IRCT20100303003485N5 IRCT 2022-07-20 Rasht University of Medical Sciences The effect of sildenafil citrate on cesarean section during labor Sildenafil citrate The effect of sildenafil citrate on fetal distress during labor and cesarean section - a double-blind clinical trial with placebo 2022-07-23 anticipated 104 Complete https://irct.ir/trial/64428 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Fetal distress in pregnancy. Intervention 1: Intervention group: a group of 104 people who received a package containing three oral capsules of sildenafil 50 mg brand Marham Darou (SDF), prepared by the pharmacy, up to a maximum of 3 doses every 6 hours. The first dose of sildenafil is given when the participant enters the labor ward for delivery (Spontaneous birth with dilatation of less than 4 cm, pregnant women who have cervical rip and induction has started for them and have effective contractions or induction of labor with oxytocin or rupture of the water sac) and the patient's blood pressure is measured every 15-30 minutes. Fetal heart rate monitoring is done and pregnancy care is ensured in both study groups. Intervention 2: Control group: a group of 104 people who received a package containing three oral capsules of Mehram Daro brand prepared by the pharmacy, receive up to 3 doses every 6 hours. The first placebo dose is given when the participant enters the labor ward for delivery(Spontaneous birth with dilatation of less than 4 cm, pregnant women who have cervical rip and induction has started for them and have effective contractions or induction of labor with oxytocin or rupture of the water sac) and the patient's blood pressure is measured every 15-30 minutes. Fetal heart rate monitoring is done and pregnancy care is ensured in both study groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.