HysteroscopyNCT06726278
Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy
A study testing Misoprostol 400mcg Tab in people with Hysteroscopy and Cervical Ripening, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
Trial summary
The goal of this prospective study is to evaluate the efficacy and safety of misoprostol for cervical ripening prior to hysteroscopy Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hysteroscopy, Cervical Ripening
- What is being tested?
- Misoprostol 400mcg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 539 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Contraindications to prostaglandins, such as:
- Allergy to prostaglandins.
- Active pelvic infection.
- Severe cardiovascular, hepatic, and/or renal disease.
- Previous uterine perforation.
- Cervical incompetence.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Hayatabad Medical Complex
Peshawar, Khyber Pukhtoonkhwa, 25000
About this study
The goal of this prospective study is to evaluate the efficacy and safety of misoprostol for cervical ripening prior to hysteroscopy
Read the 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
- Being tested
- Misoprostol 400mcg Tab, Placebo
- Keywords
- Misoprostol, Cervical Ripening, Hysteroscopy, Cervical Dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 400mcg TabDrug
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.
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: During the hysteroscopy procedure (up to 30 minutes).
Secondary outcomes (5)
Requirement for Mechanical Dilation
The proportion of patients requiring additional mechanical dilation during the hysteroscopy procedure.
Measured: During the hysteroscopy procedure (up to 30 minutes).
Procedure Time
Time taken for the entire hysteroscopy procedure, from insertion to withdrawal of the hysteroscope.
Measured: During the hysteroscopy procedure (up to 30 minutes).
VAS Pain Score
Patient-reported pain scores during the hysteroscopy procedure, assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain).
Measured: Immediately after the hysteroscopy procedure.
Incidence of Cervical Lacerations
Proportion of patients experiencing cervical lacerations during the hysteroscopy procedure.
Measured: During the hysteroscopy procedure (up to 30 minutes).
Incidence of Adverse Events
Incidence of adverse events, including cramping, bleeding, gastrointestinal discomfort, and fever.
Measured: Up to 24 hours after the hysteroscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Aug 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Collaborators
- Khyber Teaching Hospital
- Responsible party
- Principal investigator, Madiha Iqbal, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726278
- Sponsor's protocol ID
- HMCKP1
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The study is focused on internal analysis and reporting of outcomes based on aggregate data. No explicit plan for sharing IPD with other researchers is currently in place, as the focus is on publication of summarized results for public health and clinical advancement
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Misoprostol-induced Cervical Ripening Prior to Hysteroscopy
- ClinicalTrials.gov ID
- NCT06726278
- Acronym / sponsor ID
- HMCKP1
- Conditions
- Hysteroscopy, Cervical Ripening
- Keywords
- Misoprostol, Cervical Ripening, Hysteroscopy, Cervical Dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Collaborators
- Khyber Teaching Hospital
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Misoprostol 400mcg TabParticipants 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 comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Contraindications to prostaglandins, such as:
- Allergy to prostaglandins.
- Active pelvic infection.
- Severe cardiovascular, hepatic, and/or renal disease.
- Previous uterine perforation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol 400mcg TabMisoprostol 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 | Group A |
| Placeboparticipants 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 | Drug | Group B |
Primary outcome
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].
5 secondary outcomes
Requirement for Mechanical Dilation
Time frame: During the hysteroscopy procedure (up to 30 minutes).
Procedure Time
Time frame: During the hysteroscopy procedure (up to 30 minutes).
VAS Pain Score
Time frame: Immediately after the hysteroscopy procedure.
Incidence of Cervical Lacerations
Time frame: During the hysteroscopy procedure (up to 30 minutes).
Incidence of Adverse Events
Time frame: Up to 24 hours after the hysteroscopy procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No. At this time, individual participant data (IPD) will not be shared due to privacy and confidentiality considerations. The study is focused on internal analysis and reporting of outcomes based on aggregate data. No explicit plan for sharing IPD with other researchers is currently in place, as the focus is on publication of summarized results for public health and clinical advancement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol 400mcg Tab in people with Hysteroscopy and Cervical Ripening, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Ripening Success Rate (time frame: During the hysteroscopy procedure (up to 30 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.