Scar NicheNCT07271056
Sublingual Misoprostol Versus No Cervical Priming Before Hysteroscopic Resection of Symptomatic Uterine Niches
A study testing Misoprostol 200mcg Tab, Hysteroscopic resection of uterine niche and Saline-infusion Sonohysterography in people with Scar Niche and Abnormal Uterine Bleeding, run by Benha University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluated whether preoperative sublingual misoprostol can enhance the effectiveness and safety of niche resection in patients with symptomatic uterine niche. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Scar Niche, Abnormal Uterine Bleeding, Cesarean Section Complications
- What is being tested?
- Misoprostol 200mcg Tab, Hysteroscopic resection of uterine niche and Saline-infusion Sonohysterography
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Feb 2025to 30 Oct 2025
- 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
- ≥1 previous cesarean section
- Post cesarean section uterine niche confirmed by saline infusion sonohysterography (niche depth ≥2 mm)
- Residual myometrial thickness ≥2.5 mm as confirmed by saline infusion sonohysterography
- Regular cycles
- Abnormal uterine bleeding for ≥3 consecutive cycles
- Post menstrual spotting or brownish discharge ≥2 days
- Total monthly bleeding duration >7 days
Who cannot join
- Irregular cycles
- Amenorrhea
- Abnormal cervical cytology
- Acute or chronic cervicitis
- Pelvic inflammatory disease
- Endometrial polyps
Show all 9Show fewer
- Uterine fibroids
- Contraindications to spinal or general anesthesia
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Misoprostol Versus No Cervical Priming Before Hysteroscopic Resection of Symptomatic Uterine Niches: Results From a Prospective Randomized Controlled Trial
The purpose of the study is to evaluated whether preoperative sublingual misoprostol can enhance the effectiveness and safety of niche resection in patients with symptomatic uterine niche.
Read the detailed description
After eligibility and consenting, Participants with symptomatic uterine niche were randomized (1:1) to sublingual misoprostol or placebo. Baseline demographic and clinical variables (age, BMI, number of prior cesarean section, number of days of postmenstrual spotting, pelvic pain, dysmenorrhea, dyspareunia, and dysuria) were collected. Symptom severity was assessed using a visual analogue scale (VAS, 1-10). Baseline niche characteristics (residual myometrial thickness, depth, length, and width) were measured by saline infusion sonohysterography. The misoprostol group received 200 µg sublingual misoprostol tablet two hours before surgery; controls received identical placebo tablets. Hysteroscopic resection of uterine niche was performed around cycle day 10 under spinal or general anesthesia using a 9-mm resectoscope with monopolar energy and 3.5% sorbitol for uterine distension. Misoprostol-related adverse events (cramping, fever, GI upset) were recorded preoperatively by a trained nurse. The Sanders and Murji technique was adapted as follow: (1) anatomical orientation, (2) cephalic rim resection, (3) caudal rim resection, and (4) rollerball ablation of the niche base . Intraoperative data (duration, need for dilators, intra- and postoperative complications). At 3 months postoperatively, participants were reassessed for reduction in number of days of postmenstrual spotting, changes in pelvic pain, dysmenorrhea, dyspareunia, and dysuria (VAS scores), participants satisfaction (satisfied/very satisfied vs. dissatisfied/neutral), , and sonohysterographic niche measurements (RMT, depth, length, width).
The participants, hysteroscopist, outcome assessors, and the investigator were blinded for the assignment of the participants to either groups.
- Being tested
- Misoprostol 200mcg Tab, Placebo tab, Hysteroscopic resection of uterine niche, Saline-infusion Sonohysterography
- Keywords
- Misoprostol, Administration, Sublingual, Cervical Priming, Hysteroscopy, Cesarean Section Scar Defect, Randomized Controlled Trial, Postmenstrual Spotting
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 200mcg TabDrug
Also called Misotac®, Sigma Pharmaceutical Industries, Egypt
Misoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche. A trained nurse, independent of assessment, prepared and administered the medication to the participants.
Placebo tabOther
Placebo group received sublingual identical tablet two hours before hysteroscopic resection of uterine niche. A trained nurse, independent of assessment, prepared and administered the tab to the participants.
Hysteroscopic resection of uterine nicheProcedure or surgery
Procedures were performed around cycle day 10 under spinal or general anesthesia using a 9-mm resectoscope (Karl Storz, Germany) with monopolar energy and 3.5% sorbitol for uterine distension. The Sanders and Murji technique was adapted as follow: (1) anatomical orientation, (2) cephalic rim resection, (3) caudal rim resection, and (4) rollerball ablation of the niche base.
Saline-infusion SonohysterographyDiagnostic test
All participants were evaluated by a single blinded sonographer experienced in niche assessment. First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol group | Active comparator | Misoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche. Receives: Drug: Misoprostol 200mcg Tab; Procedure: Hysteroscopic resection of uterine niche; Diagnostic Test: Saline-infusion Sonohysterography |
| Placebo group | Placebo comparator | Placebo group received sublingual identical placebo tablet two hours before hysteroscopic resection of uterine niche. Receives: Other: Placebo tab; Procedure: Hysteroscopic resection of uterine niche; Diagnostic Test: Saline-infusion Sonohysterography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of days of postmenstrual spotting.
The number of days of postmenstrual spotting was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.
Measured: At 3 months postoperative.
Secondary outcomes (7)
Total bleeding days per cycle
Total bleeding days per cycle was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.
Measured: At baseline and at 3 months postoperative.
Pelvic pain score
Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.
Measured: At baseline and at 3 months postoperative.
Dysmenorrhea score
Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.
Measured: At baseline and at 3 months postoperative.
Dyspareunia score
Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.
Measured: At baseline and at 3 months postoperative.
Dysuria score
Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.
Measured: At baseline and at 3 months postoperative.
Satisfaction with the outcome
Participant satisfaction with the outcome was assessed using a binary scale (Yes when satisfied/very satisfied , No when dissatisfied/neutral).
Measured: At 3 months postoperative.
Uterine niche measurements
First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.
Measured: At baseline and at 3 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start11 Feb 2025
- Primary completion30 Jul 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Scar NicheStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Latif Ahmed Alnezamy, Benha University
- Investigators
- AHMED ALNEZAMY, MD, Principal investigator, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271056
- Sponsor's protocol ID
- RC11-2-2025
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
PubMed 29536581Zhuo Z, Yu H, Jiang X. A systematic review and meta-analysis of randomized controlled trials on the effectiveness of cervical ripening with misoprostol administration before hysteroscopy. Int J Gynaecol Obstet. 2016 Mar;132(3):272-7. doi: 10.1016/j.ijgo.2015.07.039. Epub 2015 Dec 11.
PubMed 26797202Tanha FD, Salimi S, Ghajarzadeh M. Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy: a randomized clinical trial. Arch Gynecol Obstet. 2013 May;287(5):937-40. doi: 10.1007/s00404-012-2652-4. Epub 2012 Dec 4.
PubMed 23208460Sanders AP, Murji A. Hysteroscopic repair of cesarean scar isthmocele. Fertil Steril. 2018 Aug;110(3):555-556. doi: 10.1016/j.fertnstert.2018.05.032.
PubMed 30098702Feng YL, Li MX, Liang XQ, Li XM. Hysteroscopic treatment of postcesarean scar defect. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):498-502. doi: 10.1016/j.jmig.2012.03.010. Epub 2012 May 22.
PubMed 22621994Nguyen AD, Nguyen HTT, Duong GTT, Phan TTH, Do DT, Tran DA, Nguyen TK, Nguyen TB, Ville Y. Improvement of symptoms after hysteroscopic isthmoplasty in women with abnormal uterine bleeding and expected pregnancy: A prospective study. J Gynecol Obstet Hum Reprod. 2022 Mar;51(3):102326. doi: 10.1016/j.jogoh.2022.102326. Epub 2022 Jan 25.
PubMed 35091125
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Misoprostol Versus No Cervical Priming Before Hysteroscopic Resection of Symptomatic Uterine Niches: Results From a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07271056
- Acronym / sponsor ID
- RC11-2-2025
- Keywords
- Misoprostol, Administration, Sublingual, Cervical Priming, Hysteroscopy, Cesarean Section Scar Defect, Randomized Controlled Trial, Postmenstrual Spotting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 8 Dec 2025 (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 purpose of the study is to evaluated whether preoperative sublingual misoprostol can enhance the effectiveness and safety of niche resection in patients with symptomatic uterine niche.
Detailed description
After eligibility and consenting, Participants with symptomatic uterine niche were randomized (1:1) to sublingual misoprostol or placebo. Baseline demographic and clinical variables (age, BMI, number of prior cesarean section, number of days of postmenstrual spotting, pelvic pain, dysmenorrhea, dyspareunia, and dysuria) were collected. Symptom severity was assessed using a visual analogue scale (VAS, 1-10). Baseline niche characteristics (residual myometrial thickness, depth, length, and width) were measured by saline infusion sonohysterography. The misoprostol group received 200 µg sublingual misoprostol tablet two hours before surgery; controls received identical placebo tablets. Hysteroscopic resection of uterine niche was performed around cycle day 10 under spinal or general anesthesia using a 9-mm resectoscope with monopolar energy and 3.5% sorbitol for uterine distension. Misoprostol-related adverse events (cramping, fever, GI upset) were recorded preoperatively by a trained nurse. The Sanders and Murji technique was adapted as follow: (1) anatomical orientation, (2) cephalic rim resection, (3) caudal rim resection, and (4) rollerball ablation of the niche base . Intraoperative data (duration, need for dilators, intra- and postoperative complications). At 3 months postoperatively, participants were reassessed for reduction in number of days of postmenstrual spotting, changes in pelvic pain, dysmenorrhea, dyspareunia, and dysuria (VAS scores), participants satisfaction (satisfied/very satisfied vs. dissatisfied/neutral), , and sonohysterographic niche measurements (RMT, depth, length, width).
The participants, hysteroscopist, outcome assessors, and the investigator were blinded for the assignment of the participants to either groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol group | Active comparator | Drug: Misoprostol 200mcg Tab, Procedure: Hysteroscopic resection of uterine niche, Diagnostic Test: Saline-infusion SonohysterographyMisoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche. |
| Placebo group | Placebo comparator | Other: Placebo tab, Procedure: Hysteroscopic resection of uterine niche, Diagnostic Test: Saline-infusion SonohysterographyPlacebo group received sublingual identical placebo tablet two hours before hysteroscopic resection of uterine niche. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- ≥1 previous cesarean section
- Post cesarean section uterine niche confirmed by saline infusion sonohysterography (niche depth ≥2 mm)
- Residual myometrial thickness ≥2.5 mm as confirmed by saline infusion sonohysterography
- Regular cycles
- Abnormal uterine bleeding for ≥3 consecutive cycles
Key exclusion criteria (9 listed)
- Irregular cycles
- Amenorrhea
- Abnormal cervical cytology
- Acute or chronic cervicitis
- Pelvic inflammatory disease
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 200mcg TabAlso: Misotac®, Sigma Pharmaceutical Industries, EgyptMisoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche. A trained nurse, independent of assessment, prepared and administered the medication to the participants. | Drug | Misoprostol group |
| Placebo tabPlacebo group received sublingual identical tablet two hours before hysteroscopic resection of uterine niche. A trained nurse, independent of assessment, prepared and administered the tab to the participants. | Other | Placebo group |
| Hysteroscopic resection of uterine nicheProcedures were performed around cycle day 10 under spinal or general anesthesia using a 9-mm resectoscope (Karl Storz, Germany) with monopolar energy and 3.5% sorbitol for uterine distension. The Sanders and Murji technique was adapted as follow: (1) anatomical orientation, (2) cephalic rim resection, (3) caudal rim resection, and (4) rollerball ablation of the niche base. | Procedure or surgery | Misoprostol group, Placebo group |
| Saline-infusion SonohysterographyAll participants were evaluated by a single blinded sonographer experienced in niche assessment. First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded. | Diagnostic test | Misoprostol group, Placebo group |
Primary outcome
Reduction in number of days of postmenstrual spotting.
Time frame: At 3 months postoperative.
The number of days of postmenstrual spotting was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.
7 secondary outcomes
Total bleeding days per cycle
Time frame: At baseline and at 3 months postoperative.
Pelvic pain score
Time frame: At baseline and at 3 months postoperative.
Dysmenorrhea score
Time frame: At baseline and at 3 months postoperative.
Dyspareunia score
Time frame: At baseline and at 3 months postoperative.
Dysuria score
Time frame: At baseline and at 3 months postoperative.
Satisfaction with the outcome
Time frame: At 3 months postoperative.
Uterine niche measurements
Time frame: At baseline and at 3 months postoperative.
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 16 Dec 2025.
- Background: PubMed 29536581Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.
- Background: PubMed 26797202Zhuo Z, Yu H, Jiang X. A systematic review and meta-analysis of randomized controlled trials on the effectiveness of cervical ripening with misoprostol administration before hysteroscopy. Int J Gynaecol Obstet. 2016 Mar;132(3):272-7. doi: 10.1016/j.ijgo.2015.07.039. Epub 2015 Dec 11.
- Background: PubMed 23208460Tanha FD, Salimi S, Ghajarzadeh M. Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy: a randomized clinical trial. Arch Gynecol Obstet. 2013 May;287(5):937-40. doi: 10.1007/s00404-012-2652-4. Epub 2012 Dec 4.
- Results publication: PubMed 30098702Sanders AP, Murji A. Hysteroscopic repair of cesarean scar isthmocele. Fertil Steril. 2018 Aug;110(3):555-556. doi: 10.1016/j.fertnstert.2018.05.032.
- Results publication: PubMed 22621994Feng YL, Li MX, Liang XQ, Li XM. Hysteroscopic treatment of postcesarean scar defect. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):498-502. doi: 10.1016/j.jmig.2012.03.010. Epub 2012 May 22.
- Results publication: PubMed 35091125Nguyen AD, Nguyen HTT, Duong GTT, Phan TTH, Do DT, Tran DA, Nguyen TK, Nguyen TB, Ville Y. Improvement of symptoms after hysteroscopic isthmoplasty in women with abnormal uterine bleeding and expected pregnancy: A prospective study. J Gynecol Obstet Hum Reprod. 2022 Mar;51(3):102326. doi: 10.1016/j.jogoh.2022.102326. Epub 2022 Jan 25.
- Individual participant dataSharing planned: No
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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.
AHMED ALNEZAMY, MD principal investigator
Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
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 200mcg Tab, Hysteroscopic resection of uterine niche and Saline-infusion Sonohysterography in people with Scar Niche and Abnormal Uterine Bleeding, run by Benha University at 1 site in Egypt.
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 7 inclusion and 9 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 16 Dec 2025. 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 Egypt. 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?
Reduction in number of days of postmenstrual spotting. (time frame: At 3 months postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07271056, which also lists 6 linked publications.
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 16 Dec 2025.