NCT06726278

Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 539 (actual)
• Sponsor: Hayat Abad Medical Complex, Peshawar · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hysteroscopy
• Cervical Ripening

Interventions

Type	Name	Description
DRUG	Misoprostol 400mcg Tab	Misoprostol 400 µg is a synthetic prostaglandin E1 analog used in this clinical trial to evaluate its effects in inducing uterine contractions or labor. This dosage form is typically administered orally, and its primary mechanism involves the softening and dilation of the cervix, making it a common choice in obstetric practices for labor induction. The study will evaluate its efficacy and safety profile when compared to the placebo group. Misoprostol is administered in a single dose of 400 µg, and participants will be monitored for any adverse reactions or labor-related outcomes.
DRUG	Placebo	participants will receive a placebo treatment, consisting of an inert substance that has no active pharmacological effect. The placebo is administered in the same manner (vaginally) and at the same time point as Misoprostol, but without any therapeutic action. This group is used to control for potential psychological effects of the intervention, ensuring that any observed

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2024-12-10
• Last updated: 2024-12-10

Locations

1 site across 1 country: Pakistan