Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy

Not Applicable

Completed

• Conditions: Hysteroscopy; Cervical Ripening
• Interventions: Drug: Misoprostol 400mcg Tab; Drug: Placebo

• Registration Number: NCT06726278
• Lead Sponsor: Hayat Abad Medical Complex, Peshawar.

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.

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Study First Submitted: 2024-11-30
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 539

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Misoprostol 400mcg Tab	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.
Group B	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Cervical Ripening Success Rate	During the hysteroscopy procedure (up to 30 minutes).	Proportion of patients achieving adequate cervical dilation with misoprostol alone, defined as a minimum dilation of \[specific measure, e.g., 6mm without mechanical dilation\].

Secondary Outcome Measures

Name	Time	Method
Requirement for Mechanical Dilation	During the hysteroscopy procedure (up to 30 minutes).	The proportion of patients requiring additional mechanical dilation during the hysteroscopy procedure.
Procedure Time	During the hysteroscopy procedure (up to 30 minutes).	Time taken for the entire hysteroscopy procedure, from insertion to withdrawal of the hysteroscope.
VAS Pain Score	Immediately after the hysteroscopy procedure.	Patient-reported pain scores during the hysteroscopy procedure, assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain).
Incidence of Cervical Lacerations	During the hysteroscopy procedure (up to 30 minutes).	Proportion of patients experiencing cervical lacerations during the hysteroscopy procedure.
Incidence of Adverse Events	Up to 24 hours after the hysteroscopy procedure.	Incidence of adverse events, including cramping, bleeding, gastrointestinal discomfort, and fever.

Trial Locations

Locations (1)

Hayatabad Medical Complex; 🇵🇰 Peshawar, Khyber Pukhtoonkhwa, Pakistan