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IRCT20101130005280N54 IRCT 2022-07-03 Mashhad University of Medical Sciences The Effect of Amniotic membrane graft of the fetal membrane on pain The Effect of Amniotic membrane graft of the fetal membrane on pain, infection, and repair of large episiotomy 2022-07-06 anticipated 70 Complete https://irct.ir/trial/64274 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, permutation block method was used to generate a sequence of random allocation of individuals to the study groups. Random allocation sequence was performed using random allocation software and block size four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied, Blinding description: Closed-door envelopes are used to conceal the allocation. According to the order of arrival of the research units, the envelopes are opened in order and the assigned group is revealed. 3 Complications of labour and delivery. Intervention 1: Intervention group: Newly delivered women will need an amniotic membrane transplant for fetuses who need an enlarged episiotomy to give birth. Intervention 2: Control group: Newly delivered women will need to undergo an episiotomy for labor whose episiotomy has been expanded and will undergo routine treatment. 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 After finishing work, consult with colleagues and it will be published if all members
public Farideh Akhlaghi
Razavi Khorasan Province, Mashhad, Ayatolah Bahjat St
Mashhad Iran (Islamic Republic of) 91447 34756 +98 51 3223 1061 AkhlaghiF@mums.ac.ir Mashhad University of Medical Sciences scientific Farideh Akhlaghi
Razavi Khorasan Province, Mashhad, Ayatolah Bahjat St,
Mashhad Iran (Islamic Republic of) 91447 34756 +98 51 3223 1061 AkhlaghiF@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Having informed consent to participate in the study Healthy women without specific diseases Absence of fever and infection during childbirth Need an episiotomy to deliver Expansion of the episiotomy no limit no limit Female Use of instrumental delivery Prolonged rupture of the bladder Multiple examinations and fever Long hospital stay longer than 24 hours Withdrawal from study during childbirth Failure to refer to postpartum care are among the factors excluded from the study Complications of labour and deliveryPerineal laceration during delivery Treatment - Other Treatment - Other Intervention group: Newly delivered women will need an amniotic membrane transplant for fetuses who need an enlarged episiotomy to give birth. Control group: Newly delivered women will need to undergo an episiotomy for labor whose episiotomy has been expanded and will undergo routine treatment. Severe pain at the site of episiotomy repair. Timepoint: Up to 24 hours after the intervention. Method of measurement: Using a pain ruler. Mashhad University of Medical Sciences Approved 2022-05-30 Ethics committee of Mashhad University of Medical Science Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)