Clinical trial NCT06726278: Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy
Official title: Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopy
Cervical Ripening
Keywords: Misoprostol
Cervical Ripening
Hysteroscopy
Cervical Dilation
Lead sponsor: Hayat Abad Medical Complex, Peshawar.
Sponsor class: OTHER_GOV
Collaborators: name: Khyber Teaching Hospital
First posted: 2024-12-10
Enrollment: 539
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this prospective study is to evaluate the efficacy and safety of misoprostol for cervical ripening prior to hysteroscopy

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Contraindications to prostaglandins, such as:
* Allergy to prostaglandins.
* Active pelvic infection.
* Severe cardiovascular, hepatic, and/or renal disease.
* Previous uterine perforation.
* Cervical incompetence.

Primary outcomes:
measure: Cervical Ripening Success Rate
timeFrame: During the hysteroscopy procedure (up to 30 minutes).
Secondary outcomes:
measure: Requirement for Mechanical Dilation
timeFrame: During the hysteroscopy procedure (up to 30 minutes).
measure: Procedure Time
timeFrame: During the hysteroscopy procedure (up to 30 minutes).
measure: VAS Pain Score
timeFrame: Immediately after the hysteroscopy procedure.
measure: Incidence of Cervical Lacerations
timeFrame: During the hysteroscopy procedure (up to 30 minutes).
measure: Incidence of Adverse Events
timeFrame: Up to 24 hours after the hysteroscopy procedure.
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Hayatabad Medical Complex
state: Khyber Pukhtoonkhwa
Study officials:
References: