Sponsor study identifier
observational
120
1 country
1
Study Start
June 15, 2019
Actual (reported)Primary Completion
August 30, 2019
Actual (reported)Study Completion
March 30, 2020
Actual (reported)The purpose of this study is to investigate the risk of postoperative psychiatric disorders of depression, anxiety outcomes and sexual dysfunctions and self esteem disturbance in women with morbidly adherent placenta following hysterectomy. Research hypothesis: In women with morbidly adherent placenta, We will predict, evaluate and decrease the psychological disorders following hysterectomy. Research question: Is there any difference in psychological outcome between caesarean section and caesarean hysterectomy ? This study aims to assess the psychological outcome in women with morbidly adherent placenta following hysterectomy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 31, 2019
Actual (reported)June 6, 2019
Actual (reported)June 15, 2019
Actual (reported)August 30, 2019
Actual (reported)March 30, 2020
Actual (reported)Depression
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through SCID I .Structured Clinical Interview for DSM-IV (SCID I) is a flexible semi structured diagnostic interview designed for use by trained clinicians to diagnose many adult DSM-IV axis I clinical disorders. It includes 7 diagnostic modules, focused on different diagnostic groups: mood, psychotic, substance abuse, anxiety, somatoform, eating and adjustment disorders then using Beck depression inventory scale.This is an inventory used for assessing the severity of depression state. It consists of 21 items, each of which has four responses of increasing severity. Numerical values from 0-3 are assigned each statement to indicate the degree of severity. The Arabic version will be used for the study.
Baseline
Sexual dysfunction
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through a a test which is a brief questionnaire measure of sexual functioning in women. It is 19-item questionnaire has been developed as a multidimensional self-report instrument for assessing the key dimensions of sexual function in women. It provides scores on six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction and pain) as well as a total score. The FSFI total score varies between 1.2 and 36, a score ≤ 26 defines sexual dysfunction. It is not a measure of sexual experience, knowledge, attitude, or interpersonal functioning in women. The Arabic version used in this research was a validated, reliable, and locally accepted tool for use in the assessment of female sexual disorder in the Egyptian population .
Baseline
Anxiety
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research through Taylor scale. It is performed to assess the anxiety state. This early instrument is derived from the MMPI in which the patient has to answer Yes or No to these questions, which are phrased in formal Arabic and can be understood by all those people who can read simple Arabic.
Baseline
Self-esteem disturbance
All patients will be subjected to fulfill Questionnaire after obtaining informed consent from the patients who are invited to participate in the research. The self esteem scale is an Arabic self reported questionnaire designed to assess the overall self esteem of the reporter. It measures the self view of the reporter to his capabilities in different situations, for example: social situations, interpersonal relations, future ambitions and previous accomplishments. It is composed of 30 items rated as follows: frequently = 2, sometimes = 1 and never = 0. Items indicating low self esteem are inversely scored. Scoring is done by summing the ordinary questions and inversely scored questions. Higher scores indicate higher self esteem. The instrument showed good internal consistency reliability (0.76). The construct convenient of the scale is fairly supported by factor analysis and convergent validation with other scales measuring self esteem
Baseline
Any other possible psychiatric morbidity
Baseline
Women who underwent caesarean hysterectomy
Women who underwent lower segment caesarean section
Women who underwent spontaneous Vaginal delivery
Females in child bearing period presented with morbidly adherent placenta
Ain Shams University Maternity Hospital
Cairo, Egypt
Anis TH, Gheit SA, Saied HS, Al kherbash SA. Arabic translation of Female Sexual Function Index and validation in an Egyptian population. J Sex Med. 2011 Dec;8(12):3370-8. doi: 10.1111/j.1743-6109.2011.02471.x. Epub 2011 Oct 13.
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
Amr El Shalakany, Prof
Ain Shams Maternity Hospital
120 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2019
First Posted
June 6, 2019
Study Start
June 15, 2019
Actual (reported)New Conservative Technique for Placenta Accreta Spectrum
Contact the study team to confirm eligibility.
Broome A and Wallace L, eds. (1984): Psychology and Gynecological Problems. Tavistock Publications, London.
Cunningham FG, Leveno KJ, Bloom SL, et al. (eds) (2014): Obstetrical hemorrhage. In: Williams Obstetrics, 24th ed. New York, McGraw-Hill Education, pp: 505-511
Cunningham FG, MacDonald PC, Gant NF et al. (eds) (1997): Obstetrical haemorrhage. In: Williams Obstetrics, 20th ed. Appleton& Lange: Stanford, CT, pp: 755-6.
El Missiry A (2003): Homicide and psychiatric illness, An Egyptian study. MD Thesis, Faculty of Medicine, Ain Shams University.
First MB, Spitzer RL and Williams W (1995): Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) in Handbook of Psychiatric Measures. Washington, American Psychiatric Association.
Gielchinsky Y, Mankuta D, Rojansky N, Laufer N, Gielchinsky I, Ezra Y. Perinatal outcome of pregnancies complicated by placenta accreta. Obstet Gynecol. 2004 Sep;104(3):527-30. doi: 10.1097/01.AOG.0000136084.92846.95.
Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.
O'Brien JM, Barton JR, Donaldson ES. The management of placenta percreta: conservative and operative strategies. Am J Obstet Gynecol. 1996 Dec;175(6):1632-8. doi: 10.1016/s0002-9378(96)70117-5.
Rahimzadeh A and Nazemi AR (2002): A Survey About the Effect Of Hysterectomy on Sexual Dysfunction in Patients Underwent Surgery in Sanandaj Behsat Hospital. Sci J Kurdistan Univ Med Sci; 2(3): 50-55.
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.
TAYLOR JA. A personality scale of manifest anxiety. J Abnorm Psychol. 1953 Apr;48(2):285-90. doi: 10.1037/h0056264. No abstract available.
Alipour A and Pour Y (2010): Effect of cognitive behavioral therapy in hastening recovery of women after hysterectomy surgery. J Behav Sci; 4(2):91-5
Primary Completion
August 30, 2019
Actual (reported)Study Completion
March 30, 2020
Actual (reported)Last Updated
January 12, 2021
Record last verified: 2021-01
All data resulting from this study will be published
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