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临床试验/NCT05024604
NCT05024604Unknown不适用

Hysteroscopic Findings in Women Using Progesterone Only Pills (Minipills) Prospective Cohort Study .

Samuel Gendy1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
140
试验地点
1
主要终点
primary outcome

研究概览

简要总结

Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study.

详细描述

Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study. versus women not using any hormonal therapy ,Office hysteroscopy would be conducted outside of the formal operating theater setting in an appropriately sized, equipped, and staffed treatment room with adjoining, private changing facilities and toilet. As the patient is aware of everything that is going on, it is advisable to organize a relaxed setting, using a protected space with a comfortable seat, Uterine distension:

When performing diagnostic hysteroscopic procedures, it is best if a non-viscous, physiologic solution is used i.e. Saline or Lactated Ringers as opposed to CO2 gas. CO2 is commonly used for diagnostic hysteroscopy but is difficult to use in the presence of blood or mucous. Adequate distention pressures (50-70 mmHG) can be achieved in the office by the use of gravity or a pressure bags. Most office based procedures are of short duration and no more than 2 liters of solution should be utilized. In this situation, it is not necessary to monitor fluid inflow, outflow and deficits in the office setting. The standard access approach to the cervix involves placing a speculum within the vagina (preferably side opening), placing single tenaculum on the anterior lip of the cervix, injecting the cervix with local anaesthesia (if necessary), and placing the rigid continuous flow hysteroscope within the cervical canal. In most patients, including nulliparous and post menopausal patients, it is not necessary to dilate the cervix prior to insertion. Once the hysteroscope is within the cervical canal, the speculum should be removed, the fluid flow is begun and the hysteroscope is advanced through the cervical canal and into the uterine cavity under direct visualization.

The endometrium will be inspected by outpatient hysteroscopy The following observations made at hysteroscopy, and reviewed in detail from the video record of the examination Glandular and stromal changes The color, thickness, texture and regularity of the endometrial stroma would be assessed during hysteroscopy Superficial vascular density Endometrial vascular density would be assessed at hysteroscopy by direct inspection of the blood vessels, and graded according to the abundance of superficial vessels observed. Superficial vascular density would be reassessed after uterine collapse and Re distention.

Vascular morphology The shape and configuration of superficial and deep endometrial vessels would be assessed at hysteroscopy. The presence of regular and irregular (neo vascular and mosaic) vascular patterns in superficial and deep vessels would be recorded and graded. The presence of petechiae and ecchymosis would be recorded.

All the above values were regraded after collapse and re distention of the uterus, provided that a clear view of the endometrium could be obtained.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

study group

women receiving mini pills as a method of contraception with symptoms not diagnosed with us

干预措施: Progesterone Only Product in Oral Dose Form (Drug)

study group

women receiving mini pills as a method of contraception with symptoms not diagnosed with us

干预措施: office hysterscopy (Other)

Control group

women attending to office hysteroscopy unit and not taking hormonal therapy

干预措施: office hysterscopy (Other)

结局指标

主要结局

primary outcome

时间窗: an average of 1 year

Hysteroscopic findings in women using POPs versus those not using hormones.( cervical mucosa , endometrium )

次要结局

  • subsidiary(an average of 1 year)

研究者

发起方
Samuel Gendy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Samuel Gendy

Resident of Obstetrics & Gynecology

Assiut University

研究点 (1)

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