Clinical Trial Protocol Iranian Registry of Clinical Trials

28 Sep 2021

Clinical trial of the eﬀect of amniotic membrane on post cesarean pain

Protocol summary 2016-06-30, 1395/04/10

Summary Registrant information Objective: to investigate the effect of amniotic Name membrane dressing on the pain after Caesarean section. Fatemeh Mohseni Study design: a randomized duble blind clinical trial Name of organization / entity study. Population: 90 mothers undergoing caesarean Shiraz University of Medical Sciences, Nnursing & section are enrolled in the study. Inclusion criteria: Midwifery Faculty gestational age between 38 and 42 weeks, willingness to Country participate in the study, experiencing the first cesarean Iran (Islamic Republic of) section, live and singleton pregnancy, not having any Phone kind of previous surgery, not smoking or consuming +98 71 1647 4254 alcohol and drugs, no history of known diseases (such as Email address liver and kidney dysfunction, cardiovascular, respiratory, [email protected] and neuromuscular diseases, diabetes, and hypertension), and undergoing general anesthesia. Recruitment status Exclusion criteria: the surgery last for more than 90 Recruitment complete minutes, the patients do not cooperate in measuring and Funding source recording the pain level. Patients will be divided into two Vice chancellor for research, Gerash University of groups of 45. In the intervention group after removal of Medical Sciences the placenta, the fetal amniotic membrane is separated from the placenta. The membrane is placed as double- Expected recruitment start date layered on the sutured wound. The intended intervention 2016-06-30, 1395/04/10 is applied immediately after suturing, remaining on the Expected recruitment end date wound until the removal of stitches (24 hours). In the 2016-08-31, 1395/06/10 control group, routine dressing is performed by putting Actual recruitment start date dry sterile gauze on the wound. Pain severity would be empty measured, recorded, and compared between two groups Actual recruitment end date in 4, 12, 24, 36, and 48 hours after surgery by Visual empty Analogue Scale (VAS). Trial completion date empty General information Scientific title Acronym Clinical trial of the effect of amniotic membrane on post IRCT registration information cesarean pain IRCT registration number: IRCT2016040516110N3 Public title Registration date: 2016-06-30, 1395/04/10 The effect of amniotic membrane on post cesarean pain Registration timing: registered_while_recruiting Purpose Treatment Last update: Inclusion/Exclusion criteria Update count: 0 Inclusion criteria: gestational age between 38 and 42 Registration date weeks, willingness to participate in the study,

1 experiencing the ﬁrst cesarean section, live and 1 singleton pregnancy, not having any kind of previous Description of health condition studied surgery, not smoking or consuming alcohol and drugs, no caesarean section history of known diseases (such as liver and kidney ICD-10 code dysfunction, cardiovascular, respiratory, and o82 neuromuscular diseases, diabetes, and hypertension), ICD-10 code description and undergoing general anesthesia. exclusion criteria: Single delivery by caesarean section the surgery last for more than 90 minutes, the patients do not cooperate in measuring and recording the pain level Primary outcomes Age No age limit 1 Gender Description Female pain Phase Timepoint N/A 4, 12, 24, 36, 48 hrs after caesarean Groups that have been masked Method of measurement No information VAS Sample size Target sample size: 90 Secondary outcomes Randomization (investigator's opinion) Randomized 1 Randomization description Blinding (investigator's opinion) Description Double blinded - Blinding description Timepoint Placebo - Not used Method of measurement Assignment - Parallel Other design features Intervention groups block randomization method.The patients and the researcher that will assess the pain, will be blind to the 1 kind of intervention. Description Secondary Ids Interventional group: in the intervention group after removal of the placenta, the fetal amniotic membrane is empty separated from the placenta by a gynecologist surgen. The membrane is placed as double-layered on the Ethics committees sutured wound. The intended intervention is applied immediately after suturing, remaining on the wound until the removal of stitches (24 hours). 1 Category Ethics committee Other Name of ethics committee Ethics committee of Gerash University of Medical 2 Sciences Description Street address Control group: In the control group, routine dressing is Gerash University of Medical sciences, Student Blv, performed by putting dry sterile gauze on the wound. Imam Hussain (AS) Blv, Gerash, Fars Province, Iran Category City Treatment - Drugs Gerash Postal code 58666 – 74417 Recruitment centers Approval date 2016-03-05, 1394/12/15 1 Ethics committee reference number Recruitment center IR.GERUMS.REC.1394.1014 Name of recruitment center Gerash Amir-al-Momenin medical and educational Health conditions studied center

2 Full name of responsible person Phone Fatemeh Mohseni +98 71 5244 2003 Street address Fax Gerash Amir-al-Momenin medical and educational Email center, Vahdat street, Shahid beheshti square, [email protected]; [email protected] Gerash, Fars province , Iran. Web page address City Gerash Person responsible for scientiﬁc inquiries Sponsors / Funding sources Contact 1 Name of organization / entity Gerash Amir-al-Momenin medical and educational Sponsor center Name of organization / entity Full name of responsible person Vice Chancellor for research of Gerash University of Fatemeh Mohseni Medical Sciences Position Full name of responsible person Master of science nursing Afsaneh Besharati Other areas of specialty/work Street address Street address Gerash University of Medical sciences, Student Blv, Gerash Amir-al-Momenin medical and educational Imam Hussain (AS) Blv, Gerash, Fars Province, Iran center, Vahdat street, Shahid beheshti square, City Gerash, Fars province , Iran. Gerash City Grant name Gerash Grant code / Reference number Postal code Is the source of funding the same sponsor Phone organization/entity? +98 71 5744 2002 Yes Fax Title of funding source Email Vice Chancellor for research of Gerash University of [email protected]; [email protected] Medical Sciences Web page address Proportion provided by this source 100 Person responsible for updating data Public or private sector empty Contact Domestic or foreign origin Name of organization / entity empty Gerash Amir-al-Momenin medical and educational Category of foreign source of funding center, Gerash, Fars, Iran empty Full name of responsible person Country of origin Fatemeh Mohseni Type of organization providing the funding Position empty Master of science nursing Other areas of specialty/work Person responsible for general inquiries Street address Gerash Amir-al-Momenin medical and educational Contact center, Vahdat street, Shahid beheshti square, Name of organization / entity Gerash, Fars province , Iran. Gerash Amir-al-Momenin medical and educational City center Gerash Full name of responsible person Postal code Fatemeh Mohseni Phone Position +98 71 5245 0489 Master of science nursing Fax Other areas of specialty/work Email Street address [email protected]; [email protected] Gerash Amir-al-Momenin medical and educational Web page address center, Vahdat street, Shahid beheshti square, Gerash, Fars province , Iran. Sharing plan City Gerash Deidentiﬁed Individual Participant Data Set (IPD) Postal code empty

3 Study Protocol Clinical Study Report empty empty Statistical Analysis Plan Analytic Code empty empty Informed Consent Form Data Dictionary empty empty