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IRCT20190305042927N1 IRCT 2020-07-26 Shahid Beheshti University of Medical Sciences the effect of aloe vera gel on prevention of SG Evaluating the effect of aloe vera gel on prevention of SG in nulliparous woman 2019-06-01 anticipated 90 Complete https://irct.ir/trial/38083 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using random allocation software1.0, A simple random list of 3 groups with codes A, B and C for 90 participants was prepared and presented by a statistical consultant. The codes were placed in envelopes in the order of the list provided in the form of small cards by the research colleague, the lids of the envelopes were pasted and the envelopes were numbered in the order in the list obtained from the random assignment software. Envelopes were given to the researcher who was doing the sampling. Eligible individuals were opened to enter the study envelope in order and the group was identified, Blinding description: Researchers, participants, and data analyzers were not aware of the gel type. After preparing by the Pharmacognosy Center, the gels were named in the same package with codes A and B. At the end of the data analysis, the results were announced to the Pharmacognosy Center and the type of gel of each code was announced by that center.At the same time, the research colleague, who evaluated the outcome by observing and completing the observation checklist, did not know what the study groups (A, B, C) were receiving. 3 Striea gravidarum. Intervention 1: "Intervention group:" Receive aloe vera gel 75% from the 20th week of pregnancy to 28 pregnancies once a day in the amount of 5 grams or the equivalent of approximately 3 fingertips with 2 minutes of massage on the entire abdomen. Intervention 2: "Control group 1:" Receive placebo gel (Base gel without active ingredient) from the 20th week of pregnancy to 28 pregnancies once a day in the amount of 5 grams or approximately the equivalent of 3 fingertips with 2 minutes of massage on the entire abdomen. Intervention 3: "Control group 2:" During the study (28-20 weeks of pregnancy) did not use any substance in the abdomen. Yes - There is a plan to make this available What will be shared: Official request through corresponding researcher When: One year after article published. To whom: Universities and Research Centers Conditions: Confidentiality and obtaining permission from the main researcher Where to obtain: Corresponding authors' email How to obtain: After emailing and stating the reason for asking for the dat Comments:
public Sahar Bagherian
Vali-Asr Avenue, Vali-Asr and Neiaiesh Highway Intersection, Opposite Rajae Hospital, Nursing and Midwifery School
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8820 2512 bagherian.midwife94@gmail.com Shahid Beheshti University of Medical Sciences scientific Nourossadat Kariman
Vali-Asr Avenue, Vali-Asr and Neiaiesh Highway Intersection, Opposite Rajaee Heart Hospital,School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8820 2512 n_kariman@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Nulliparus Single pregnancy Age:20-35 year 20 years 35 years Female History of previous striae in the abdomen History of skin diseases Treatment - Drugs Placebo N/A "Intervention group:" Receive aloe vera gel 75% from the 20th week of pregnancy to 28 pregnancies once a day in the amount of 5 grams or the equivalent of approximately 3 fingertips with 2 minutes of massage on the entire abdomen. "Control group 1:" Receive placebo gel (Base gel without active ingredient) from the 20th week of pregnancy to 28 pregnancies once a day in the amount of 5 grams or approximately the equivalent of 3 fingertips with 2 minutes of massage on the entire abdomen. "Control group 2:" During the study (28-20 weeks of pregnancy) did not use any substance in the abdomen Stria score in the Davy checklist. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Davy method: The number of striae in each quarter of the abdomen is scored: "Score zero, no striae", "score one, number 2 striae", "score two, number 3-3 striae" and a total score of 0-0. . The final evaluation of striae severity is done in three groups: "zero without striae", "2-1 moderate striae" and "3-8 severe striae". Severity ofstriae pruritus. Timepoint: 8 weeks after the intervention. Method of measurement: It was evaluated by Kamini method with a score of 4-0. Without itching "score 0", mild itching (1-2 times a day) "score 1", moderate itching without disruption of daily work (3-4 times a day) "score 2", severe itching (6- 5 times a day) annoying daily work "score 3" and severe itching throughout the day and disturbing work and sleep "score 4". Severity of striae erythema. Timepoint: 8 weeks after the intervention. Method of measurement: By the way of Atval Assessed with a score of 3-0: no erythema "score 0", moderate erythema (bright red or pink) "score 1", symptomatic erythema (red) "score 2", severe erythema (purple) "score 3" Was considered. Shahid Beheshti University of Medical Sciences Approved 2019-02-03 Ethics committee of Shahid beheshti University of Medical Sciences Yemen St. - Shahid Abbas Arabi St. (Parvaneh) - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Health Services - Headquarters Building 2- Floor 5- Deputy of Research and Technology Tehran Tehran Iran (Islamic Republic of)