Psychological Outcome of Women With Morbidly Adherent Placenta Following Hystrectomy: Prospective Matched Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sexual dysfunction
研究概览
简要总结
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.
详细描述
Morbidly adherent placenta, which describes placenta accreta, increta, and percreta, implies an abnormal implantation of the placenta into the uterine wall.
The incidence of placenta accreta has increased significantly over the past several decades, with the main risk factors include prior cesarean section and placental previa.
However, no well-designed trials have yet assessed the psychological outcome of women with morbidly adherent placenta following hystrectomy. The investigators will conduct a prospective matched case control trial to evaluate the psychological outcome to assess the risk of depression ,anxiety , sexual dysfunctions and self esteem disturbance following hysterectomy in women with morbidly adherent placenta.
This Prospective matched case-control trial will take place at Ain Shams University Maternity Hospital. Women in child bearing period, with morbidly adherent placenta will be eligible for inclusion.
Placenta accreta (Morbidly adherent placenta) is a condition in which all or part of the placenta is adherent to the uterine wall because of myometrial invasion by chorionic villi. It may occur when there is either a primary deficiency of or a secondary damage to chorionic villi or Nitabuch's layer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The 3 groups should be matched in age and parity. Age of child bearing period. Women who delivered from 4-6 months ago. At a gestational age after age of viability (28 weeks).
排除标准
- •Pre-existing psychological disorders.
结局指标
主要结局
Sexual dysfunction
时间窗: Baseline
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 .
Depression
时间窗: Baseline
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.
Self-esteem disturbance
时间窗: Baseline
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
Anxiety
时间窗: Baseline
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.
次要结局
- Any other possible psychiatric morbidity(Baseline)
研究者
Mostafa R Bakry, MBBCh
The principal investigator
Ain Shams Maternity Hospital