Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 539
- 试验地点
- 1
- 主要终点
- Cervical Ripening Success Rate
研究概览
简要总结
The goal of this prospective study is to evaluate the efficacy and safety of misoprostol for cervical ripening prior to hysteroscopy
详细描述
This prospective study was conducted at Gynecology Department of Hayatabad Medical Complex Peshawar from Aug 2022 to July 2024. Total 539 women's whose elective hysteroscopy was planned were enrolled. Eligible subjects were non-pregnant women between the ages of 18-45, and were confirmed to be so with a negative urine pregnancy test. Before undergoing hysteroscopy, the participants required to have indicators for hysteroscopy (atypical bleeding per vagina and/or infertility; at suspected pathology in utero), with no previous history of surgery or significant cervical pathologies. Exclusion criteria were: any contraindication, such as allergy to prostaglandins, active pelvic infection; severe cardiovascular, hepatic and/or renal disease or previous uterine perforation/cervical incompetence. Approval from Institutional Review Board was obtained under ref # 860. Patients were divided into two groups based on the administration of misoprostol: Group A (n=300) received 400 µg of misoprostol, administered vaginally, 12 hours prior to the scheduled hysteroscopy. Group B (n=239) did not receive misoprostol and served as the control group. Patients and the clinicians who undertook hysteroscopy were blinded to group assignments. It ordered the misoprostol and placebo tablets separately from a hospital pharmacy so they would look identical.
Hysteroscopic Procedure All hysteroscopic procedures were done in the standard conditions with 5.50 mm rigid Hysteroscope (Karl Storz, Germany). The patients were placed in the lithotomy position, and a tenaculum was used to apply anteflexion of the cervix before insertion. The cervical dilation achieved was measured using Hegar dilators in increments of 1 mm until the hysteroscope could be inserted without resistance.
The primary outcome was the amount of cervical dilation achieved on entry to hysteroscopy. The secondary outcomes were: requirement for mechanical dilation, procedure time (from hysteroscope insertion to withdrawal), patient-reported pain score using Visual Analog Scale (VAS) during the procedures, incident of cervical laceration and adverse events including cramping, bleeding per vagina abnormal gastrointestinal discomfort and fever.
Data Collection / analysis Age, parity, and the reason for hysteroscopy were among the baseline demographic data that were gathered. Information was documented during the hysteroscopic procedure, including cervical dilatation, procedure duration, and any complications. Following the surgery, patients used the Visual Analog Scale (VAS) to rate their level of pain. After the surgery, adverse effects were tracked and recorded for up to 24 hours. Using SPSS version 25.0, statistical analysis was carried out, with a significance level set at p-value ≤0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Although this study is an observational study, masking was used to minimize bias in the assessment of outcomes. The participants were blinded to the group allocation (misoprostol or placebo). Additionally, the care providers performing the hysteroscopic procedures were also blinded to the group assignments to avoid any bias in procedural conduct or outcome reporting.
The investigators and outcomes assessors involved in the data analysis were also unaware of the group allocation, ensuring impartial evaluation of the results. This blinding process was maintained throughout the study to minimize bias and enhance the reliability of the observed outcomes.
Since this study does not involve random assignment or an investigational treatment, it is important to note that masking was implemented as part of the observational design to preserve the validity of the findings, despite the lack of intervention assignment typically seen in clinical trials.
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant women aged 18-45 years.
- •Confirmed non-pregnancy with a negative urine pregnancy test.
- •No history of prior surgery or significant cervical pathologies.
- •Atypical bleeding per vagina.
- •Infertility.
- •Suspected uterine pathology.
排除标准
- •Contraindications to prostaglandins, such as:
- •Allergy to prostaglandins.
- •Active pelvic infection.
- •Severe cardiovascular, hepatic, and/or renal disease.
- •Previous uterine perforation.
- •Cervical incompetence.
研究组 & 干预措施
Group A
Participants in this group will receive Misoprostol 400 µg, administered orally. This arm is designed to evaluate the efficacy and safety of Misoprostol for the intended clinical outcome.
干预措施: Misoprostol 400mcg Tab (Drug)
Group B
Participants in this group will receive a placebo that matches the Misoprostol formulation in appearance, but contains no active ingredients. This arm serves as a control to compare the effects of Misoprostol with a non-active substance.
干预措施: Placebo (Drug)
结局指标
主要结局
Cervical Ripening Success Rate
时间窗: During the hysteroscopy procedure (up to 30 minutes).
Proportion of patients achieving adequate cervical dilation with misoprostol alone, defined as a minimum dilation of \[specific measure, e.g., 6mm without mechanical dilation\].
次要结局
- Requirement for Mechanical Dilation(During the hysteroscopy procedure (up to 30 minutes).)
- Procedure Time(During the hysteroscopy procedure (up to 30 minutes).)
- VAS Pain Score(Immediately after the hysteroscopy procedure.)
- Incidence of Cervical Lacerations(During the hysteroscopy procedure (up to 30 minutes).)
- Incidence of Adverse Events(Up to 24 hours after the hysteroscopy procedure.)
研究者
Madiha Iqbal
Assistant Professor
Hayat Abad Medical Complex, Peshawar.
