Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy

NCT06726278 | Completed

• 1 other identifier: HMCKP1
• Study Type: interventional
• Target: 539
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hysteroscopy; Cervical Ripening

Keywords

Misoprostol; Cervical Ripening; Hysteroscopy; Cervical Dilation

Outcome Measures

Primary Outcomes (1)

• Cervical Ripening Success Rate

  Proportion of patients achieving adequate cervical dilation with misoprostol alone, defined as a minimum dilation of \[specific measure, e.g., 6mm without mechanical dilation\].

  During the hysteroscopy procedure (up to 30 minutes).

Secondary Outcomes (5)

• Requirement for Mechanical Dilation

  During the hysteroscopy procedure (up to 30 minutes).

• Procedure Time

  During the hysteroscopy procedure (up to 30 minutes).

• VAS Pain Score

  Immediately after the hysteroscopy procedure.

• Incidence of Cervical Lacerations

  During the hysteroscopy procedure (up to 30 minutes).

• Incidence of Adverse Events

  Up to 24 hours after the hysteroscopy procedure.

Study Arms (2)

Group A

EXPERIMENTAL

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.

Drug: Misoprostol 400mcg Tab

Group B

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

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.

Group A

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

Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead
• Khyber Teaching Hospital: collaborator

Study Sites (1)

Hayatabad Medical Complex

Peshawar, Khyber Pukhtoonkhwa, 25000, Pakistan

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 10, 2024
• Study Start: August 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)