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Completed

NCT Number: NCT06726278

Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hayatabad Medical Complex

Peshawar, Khyber Pukhtoonkhwa, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol 400mcg Tab

Drug

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.

Placebo

Drug

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

Primary outcomes

  1. Cervical Ripening Success Rate

    Time frame: 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 outcomes

  1. Requirement for Mechanical Dilation

    Time frame: During the hysteroscopy procedure (up to 30 minutes).

    The proportion of patients requiring additional mechanical dilation during the hysteroscopy procedure.

  2. Procedure Time

    Time frame: During the hysteroscopy procedure (up to 30 minutes).

    Time taken for the entire hysteroscopy procedure, from insertion to withdrawal of the hysteroscope.

  3. VAS Pain Score

    Time frame: 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).

  4. Incidence of Cervical Lacerations

    Time frame: During the hysteroscopy procedure (up to 30 minutes).

    Proportion of patients experiencing cervical lacerations during the hysteroscopy procedure.

  5. Incidence of Adverse Events

    Time frame: Up to 24 hours after the hysteroscopy procedure.

    Incidence of adverse events, including cramping, bleeding, gastrointestinal discomfort, and fever.

Sponsors and collaborators

Lead sponsor

Hayat Abad Medical Complex, Peshawar

Other Gov

Collaborators

  • Khyber Teaching Hospital

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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