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IRCT20120718010324N55 IRCT 2020-05-27 Tabriz University of Medical Sciences The effect of vaginal oxytocin on sexual function in lactating women The effect of vaginal oxytocin on sexual function in lactating women: a randomised controlled trial 2020-05-29 anticipated 68 Complete https://irct.ir/trial/44986 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4 and 6 and the allocation ratio of 1:1. A person not involved in the sampling will generate allocation sequence, Blinding description: The participants researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research. 2-3 Sexual dysfunctionse. Intervention 1: The intervention group will receive oxytocin vaginal jel daily for 8 weeks. Intervention 2: The control group will receive placebo vaginal jel daily for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants data is confidential.
public Arezu Mesbahi
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3441 5907 arezumesbahimidwife@gmail.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 mirghaforvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Lactating women Passing at least 6 weeks and 6 months after delivery Female Sexual Function Index (FSFI) score less than 26.5 at the initial evaluation Having a depression score of less than 13 based on the Edinburg Postpartum Depression Scale Having active life based on sexual relationship no limit no limit Female Pregnant women A history of grief and postpartum depression A history of taking depression and other psychiatric drugs History of hormone therapy for sexual dysfunction during the past two weeks A history of chemotherapy or pelvic radiation therapy Any chronic and uncontrolled illness such as diabetes F52 Sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Placebo The intervention group will receive oxytocin vaginal jel daily for 8 weeks. The control group will receive placebo vaginal jel daily for 8 weeks. Sexual function. Timepoint: Before and 8 weeks after intervention. Method of measurement: Female Sexual Function Index. Sexual satisfaction. Timepoint: Before and 8 weeks after intervention. Method of measurement: Sexual Satisfaction Scale for Women. Depression. Timepoint: Before and 8 weeks after intervention. Method of measurement: Edinbuurgh Postnatal Depression Scale. Tabriz University of Medical Sciences Approved 2020-05-14 Ethics committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan Tabriz East Azarbaijan Iran (Islamic Republic of)