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Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy

NCT ID: NCT06726278

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

539 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-07-30

Brief Summary

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

Detailed Description

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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

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Hysteroscopy Cervical Ripening

Keywords

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Misoprostol Cervical Ripening Hysteroscopy Cervical Dilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Misoprostol 400mcg Tab

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Khyber Teaching Hospital

OTHER

Sponsor Role collaborator

Hayat Abad Medical Complex, Peshawar.

OTHER_GOV

Sponsor Role lead

Responsible Party

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Madiha Iqbal

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hayatabad Medical Complex

Peshawar, Khyber Pukhtoonkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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HMCKP1

Identifier Type: -

Identifier Source: org_study_id