Abnormal Uterine BleedingNCT07229209
Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for Niche-Related Abnormal Uterine Bleeding
A study testing transvaginal ultrasonography, monophasic combined oral contraceptive pill and 52 mg levonorgestrel-releasing intrauterine system in people with Abnormal Uterine Bleeding and Cesarean Section Complications, run by Benha University at 1 site in Egypt.
Trial summary
The purpose of the study is to compare the clinical efficacy and niche morphological changes following treatment with combined oral contraceptive pills (OCPs) versus a levonorgestrel-releasing intrauterine system (LNG-IUS) in women with symptomatic uterine niche-related abnormal uterine bleeding (AUB). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Cesarean Section Complications, Uterine Scar
- What is being tested?
- transvaginal ultrasonography, monophasic combined oral contraceptive pill and 52 mg levonorgestrel-releasing intrauterine system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2025to 1 Nov 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
- women with at least one previous cesarean section.
- presenting with postmenstrual or intermenstrual bleeding for ≥3 consecutive cycles lasting ≥2 days, and a total bleeding duration >7 days per cycle.
- All participants had a transvaginal ultrasound-confirmed uterine niche ≥2 mm in depth.
Who cannot join
- pregnancy
- malignancy
- other identifiable causes of abnormal uterine bleeding
- abnormal cervical cytology
- cervicitis
- pelvic inflammatory disease
Show all 11Show fewer
- endometrial polyps
- uterine fibroids
- contraindications to either combined oral contraceptive pill or levonorgestrel-releasing intrauterine system
- desire for pregnancy
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for the Management of Niche-Related Abnormal Uterine Bleeding: A Prospective Open-Label Randomized Controlled Trial
The purpose of the study is to compare the clinical efficacy and niche morphological changes following treatment with combined oral contraceptive pills (OCPs) versus a levonorgestrel-releasing intrauterine system (LNG-IUS) in women with symptomatic uterine niche-related abnormal uterine bleeding (AUB).
Read the detailed description
After eligibility and consenting, participants were randomized in a 1:1 ratio using a computer-generated block randomization list (block size of six). Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes, which were opened after consent.
All participants had a transvaginal ultrasound-confirmed uterine niche ≥2 mm in depth. Residual myometrial thickness, niche depth, length, and width were assessed.
- OCP group: Participants received a monophasic combined oral contraceptive pill containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), taken for 21 days starting on day 2 of menstruation for six consecutive cycles.
- LNG-IUS group: Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first three days of menstruation for 6 months.
Both treatments were provided free of charge. Participants could switch to the alternative method upon study completion. Because of the nature of the interventions, blinding was not feasible; hence, the trial was open-label. Assessments were performed at baseline and at 1, 3, and 6 months. Participants recorded:
- Number of days of postmenstrual/intermenstrual spotting
- Total bleeding duration per cycle
- Pelvic pain and dysmenorrhea scores (10-point visual analogue scale)
- Sexual well-being (FSFI-6 score)
- Treatment satisfaction (satisfied/very satisfied vs. other responses)
- Adverse events, complications, and reasons for discontinuation (including LNG-IUS expulsion) At 6 months, transvaginal ultrasonography was repeated to assess residual myometrial thickness, niche depth, length, and width.
- Being tested
- transvaginal ultrasonography, monophasic combined oral contraceptive pill, 52 mg levonorgestrel-releasing intrauterine system
- Keywords
- cesarean scar defect, Uterine niche, abnormal uterine bleeding, oral contraceptive pills, levonorgestrel intrauterine system, randomized controlled trial
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal ultrasonographyDiagnostic test
At baseline and at 6 months after the start of treatment, transvaginal ultrasonography was performed to assess residual myometrial thickness, niche depth, length, and width.
monophasic combined oral contraceptive pillDrug
Also called Technospiron
Participants received a monophasic combined oral contraceptive pills containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles.
52 mg levonorgestrel-releasing intrauterine systemDevice
Also called Mirena
Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first 5 days of menstruation for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| combined oral contraceptive pill group | Active comparator | Participants received a monophasic combined oral contraceptive pill containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles. Receives: Diagnostic Test: transvaginal ultrasonography; Drug: monophasic combined oral contraceptive pill |
| levonorgestrel-releasing intrauterine system group | Active comparator | Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first 5 days of menstruation for 6 months. Receives: Diagnostic Test: transvaginal ultrasonography; Device: 52 mg levonorgestrel-releasing intrauterine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline.
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls.
Measured: at baseline and at 6 months post randomization
Secondary outcomes (10)
The total number of postmenstrual and/or intermenstrual spotting days per cycle.
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls.
Measured: at baseline and at 1, 3, and 6 months post randomization
Total bleeding duration per cycle
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls. It includes days of menstruation plus days of spotting
Measured: at baseline and at 1, 3, and 6 months post randomization
Pelvic pain scores
Participants recorded this on 10-point visual analogue scale where 0 means no pain and 10 means intense pain.
Measured: at baseline and at 1, 3, and 6 months
dysmenorrhea scores
Participants recorded this on 10-point visual analogue scale where 0 means no pain and 10 means intense pain.
Measured: at baseline and at 1, 3, and 6 months post randomization
Sexual function
Assessed using the validated 6-item Female Sexual Function Index (FSFI-6). The FSFI-6 score is the sum of the participant ordinal responses to the six items; the score can range from 2 to 30. Female sexual dysfunction is diagnosed if the total score is ≤ 19 (Isidori et al., J Sex Med 2010)
Measured: at baseline and at 1, 3, and 6 months post randomization
Treatment satisfaction
Participants recorded on a 5-point Likert scale (where 1 means very dissatisfied and 5 means very satisfied), then dichotomized for analysis as yes for "Satisfied/Very Satisfied" and no for other responses.
Measured: at 1, 3, and 6 months post randomization
Anatomical Niche Changes
Assessed via transvaginal ultrasonography including residual myometrial thickness, niche depth, length, and width.
Measured: at baseline and at 6 months post randomization
Adverse events
Participants reported this to the main investigator via follow up visits or telephone calls
Measured: at 1, 3, and 6 months post randomization
Complications
Participants reported this to the main investigator via follow up visits or telephone calls
Measured: At 1, 3, and 6 months post randomization
Reasons for discontinuation
Participants reported this to the main investigator via follow up visits or telephone calls
Measured: At 1, 3, and 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start5 Feb 2025
- Primary completion1 May 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Abnormal Uterine BleedingStudies 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
- None (open label)
- Enrolment
- 166 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
- NCT07229209
- Sponsor's protocol ID
- RC10-2-2025
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.
PubMed 21858885Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5.
PubMed 27393285Vikhareva Osser O, Valentin L. Clinical importance of appearance of cesarean hysterotomy scar at transvaginal ultrasonography in nonpregnant women. Obstet Gynecol. 2011 Mar;117(3):525-532. doi: 10.1097/AOG.0b013e318209abf0.
PubMed 21343754Donnez O. Cesarean scar defects: management of an iatrogenic pathology whose prevalence has dramatically increased. Fertil Steril. 2020 Apr;113(4):704-716. doi: 10.1016/j.fertnstert.2020.01.037.
PubMed 32228874Jordans 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 29536581Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1.
PubMed 19968774Stavridis K, Balafoutas D, Vlahos N, Joukhadar R. Current surgical treatment of uterine isthmocele: an update of existing literature. Arch Gynecol Obstet. 2025 Jan;311(1):13-24. doi: 10.1007/s00404-024-07880-w. Epub 2024 Dec 16.
PubMed 39680143Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.
PubMed 37506497Murji A, Sanders AP, Monteiro I, Haiderbhai S, Matelski J, Walsh C, Abbott JA, Munro MG, Maheux-Lacroix S; International Federation of Gynecology and Obstetrics (FIGO) Committee on Menstrual Disorders and Related Health Impacts. Cesarean scar defects and abnormal uterine bleeding: a systematic review and meta-analysis. Fertil Steril. 2022 Oct;118(4):758-766. doi: 10.1016/j.fertnstert.2022.06.031. Epub 2022 Aug 17.
PubMed 35985862You SH. The symptomatic cesarean scar defect with oral contraceptive pills treatment following evacuation of a cesarean scar pregnancy. Taiwan J Obstet Gynecol. 2023 Jan;62(1):181-183. doi: 10.1016/j.tjog.2022.04.012. No abstract available.
PubMed 36720538Chen YY, Tsai CC, Lan KC, Ou YC. Preliminary report on the use of a levonorgestrel intrauterine system for the treatment of intermenstrual bleeding due to previous cesarean delivery scar defect. J Obstet Gynaecol Res. 2019 Oct;45(10):2015-2020. doi: 10.1111/jog.14060. Epub 2019 Aug 5.
PubMed 31381242Zhang J, Zhu C, Yan L, Wang Y, Zhu Q, He C, He X, Ji S, Tian Y, Xie L, Liang Y, Xia W, Mol BW, Huirne JAF. Comparing levonorgestrel intrauterine system with hysteroscopic niche resection in women with postmenstrual spotting related to a niche in the uterine cesarean scar: a randomized, open-label, controlled trial. Am J Obstet Gynecol. 2023 Jun;228(6):712.e1-712.e16. doi: 10.1016/j.ajog.2023.03.020. Epub 2023 Mar 17.
PubMed 36935068Zhang X, Yang M, Wang Q, Chen J, Ding J, Hua K. Prospective evaluation of five methods used to treat cesarean scar defects. Int J Gynaecol Obstet. 2016 Sep;134(3):336-9. doi: 10.1016/j.ijgo.2016.04.011. Epub 2016 Jun 30.
PubMed 27473332Zheng F, Chen S, Yang W, Li J, Huang Q, Qin H, Wei J, Lin J. Comparison of the efficacy of oral contraceptives and levonorgestrel intrauterine system in intermenstrual bleeding caused by uterine niche. Ginekol Pol. 2024;95(8):621-626. doi: 10.5603/GP.a2023.0067. Epub 2023 Jul 7.
PubMed 37417378
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Contraceptive Pills Versus Levonorgestrel-Releasing Intrauterine System for the Management of Niche-Related Abnormal Uterine Bleeding: A Prospective Open-Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07229209
- Acronym / sponsor ID
- RC10-2-2025
- Keywords
- cesarean scar defect, Uterine niche, abnormal uterine bleeding, oral contraceptive pills, levonorgestrel intrauterine system, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 14 Nov 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 compare the clinical efficacy and niche morphological changes following treatment with combined oral contraceptive pills (OCPs) versus a levonorgestrel-releasing intrauterine system (LNG-IUS) in women with symptomatic uterine niche-related abnormal uterine bleeding (AUB).
Detailed description
After eligibility and consenting, participants were randomized in a 1:1 ratio using a computer-generated block randomization list (block size of six). Allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes, which were opened after consent.
All participants had a transvaginal ultrasound-confirmed uterine niche ≥2 mm in depth. Residual myometrial thickness, niche depth, length, and width were assessed.
- OCP group: Participants received a monophasic combined oral contraceptive pill containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), taken for 21 days starting on day 2 of menstruation for six consecutive cycles.
- LNG-IUS group: Participants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first three days of menstruation for 6 months.
Both treatments were provided free of charge. Participants could switch to the alternative method upon study completion. Because of the nature of the interventions, blinding was not feasible; hence, the trial was open-label. Assessments were performed at baseline and at 1, 3, and 6 months. Participants recorded:
- Number of days of postmenstrual/intermenstrual spotting
- Total bleeding duration per cycle
- Pelvic pain and dysmenorrhea scores (10-point visual analogue scale)
- Sexual well-being (FSFI-6 score)
- Treatment satisfaction (satisfied/very satisfied vs. other responses)
- Adverse events, complications, and reasons for discontinuation (including LNG-IUS expulsion) At 6 months, transvaginal ultrasonography was repeated to assess residual myometrial thickness, niche depth, length, and width.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined oral contraceptive pill group | Active comparator | Diagnostic Test: transvaginal ultrasonography, Drug: monophasic combined oral contraceptive pillParticipants received a monophasic combined oral contraceptive pill containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles. |
| levonorgestrel-releasing intrauterine system group | Active comparator | Diagnostic Test: transvaginal ultrasonography, Device: 52 mg levonorgestrel-releasing intrauterine systemParticipants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first 5 days of menstruation for 6 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women with at least one previous cesarean section.
- presenting with postmenstrual or intermenstrual bleeding for ≥3 consecutive cycles lasting ≥2 days, and a total bleeding duration >7 days per cycle.
- All participants had a transvaginal ultrasound-confirmed uterine niche ≥2 mm in depth.
Key exclusion criteria (11 listed)
- pregnancy
- malignancy
- other identifiable causes of abnormal uterine bleeding
- abnormal cervical cytology
- cervicitis
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 |
|---|---|---|
| transvaginal ultrasonographyAt baseline and at 6 months after the start of treatment, transvaginal ultrasonography was performed to assess residual myometrial thickness, niche depth, length, and width. | Diagnostic test | combined oral contraceptive pill group, levonorgestrel-releasing intrauterine system group |
| monophasic combined oral contraceptive pillAlso: TechnospironParticipants received a monophasic combined oral contraceptive pills containing 0.03 mg ethinyl estradiol and 3 mg drospirenone (Technospiron® 0.03/3 mg, Technopharm, Egypt), starting on day 2-5 of menstruation for 21 days followed by a 7-day hormone-free interval, for six consecutive cycles. | Drug | combined oral contraceptive pill group |
| 52 mg levonorgestrel-releasing intrauterine systemAlso: MirenaParticipants received a 52 mg levonorgestrel-releasing intrauterine system (Mirena®, Bayer, Oy Finland), inserted under transvaginal ultrasound guidance within the first 5 days of menstruation for 6 months. | Device | levonorgestrel-releasing intrauterine system group |
Primary outcome
The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline.
Time frame: at baseline and at 6 months post randomization
Participants had recorded daily bleeding data in structured, paper menstrual diaries that were prospectively given to them with proper guidance of how to fill them in a right way and then they were reviewed for completeness during follow-up visits/calls.
10 secondary outcomes
The total number of postmenstrual and/or intermenstrual spotting days per cycle.
Time frame: at baseline and at 1, 3, and 6 months post randomization
Total bleeding duration per cycle
Time frame: at baseline and at 1, 3, and 6 months post randomization
Pelvic pain scores
Time frame: at baseline and at 1, 3, and 6 months
dysmenorrhea scores
Time frame: at baseline and at 1, 3, and 6 months post randomization
Sexual function
Time frame: at baseline and at 1, 3, and 6 months post randomization
Treatment satisfaction
Time frame: at 1, 3, and 6 months post randomization
Anatomical Niche Changes
Time frame: at baseline and at 6 months post randomization
Adverse events
Time frame: at 1, 3, and 6 months post randomization
Complications
Time frame: At 1, 3, and 6 months post randomization
Reasons for discontinuation
Time frame: At 1, 3, and 6 months post randomization
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 20 Feb 2026.
- Background: PubMed 21858885Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.
- Background: PubMed 27393285Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5.
- Background: PubMed 21343754Vikhareva Osser O, Valentin L. Clinical importance of appearance of cesarean hysterotomy scar at transvaginal ultrasonography in nonpregnant women. Obstet Gynecol. 2011 Mar;117(3):525-532. doi: 10.1097/AOG.0b013e318209abf0.
- Background: PubMed 32228874Donnez O. Cesarean scar defects: management of an iatrogenic pathology whose prevalence has dramatically increased. Fertil Steril. 2020 Apr;113(4):704-716. doi: 10.1016/j.fertnstert.2020.01.037.
- 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 19968774Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1.
- Results publication: PubMed 39680143Stavridis K, Balafoutas D, Vlahos N, Joukhadar R. Current surgical treatment of uterine isthmocele: an update of existing literature. Arch Gynecol Obstet. 2025 Jan;311(1):13-24. doi: 10.1007/s00404-024-07880-w. Epub 2024 Dec 16.
- Results publication: PubMed 37506497Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.
- Results publication: PubMed 35985862Murji A, Sanders AP, Monteiro I, Haiderbhai S, Matelski J, Walsh C, Abbott JA, Munro MG, Maheux-Lacroix S; International Federation of Gynecology and Obstetrics (FIGO) Committee on Menstrual Disorders and Related Health Impacts. Cesarean scar defects and abnormal uterine bleeding: a systematic review and meta-analysis. Fertil Steril. 2022 Oct;118(4):758-766. doi: 10.1016/j.fertnstert.2022.06.031. Epub 2022 Aug 17.
- Results publication: PubMed 36720538You SH. The symptomatic cesarean scar defect with oral contraceptive pills treatment following evacuation of a cesarean scar pregnancy. Taiwan J Obstet Gynecol. 2023 Jan;62(1):181-183. doi: 10.1016/j.tjog.2022.04.012. No abstract available.
- Results publication: PubMed 31381242Chen YY, Tsai CC, Lan KC, Ou YC. Preliminary report on the use of a levonorgestrel intrauterine system for the treatment of intermenstrual bleeding due to previous cesarean delivery scar defect. J Obstet Gynaecol Res. 2019 Oct;45(10):2015-2020. doi: 10.1111/jog.14060. Epub 2019 Aug 5.
- Results publication: PubMed 36935068Zhang J, Zhu C, Yan L, Wang Y, Zhu Q, He C, He X, Ji S, Tian Y, Xie L, Liang Y, Xia W, Mol BW, Huirne JAF. Comparing levonorgestrel intrauterine system with hysteroscopic niche resection in women with postmenstrual spotting related to a niche in the uterine cesarean scar: a randomized, open-label, controlled trial. Am J Obstet Gynecol. 2023 Jun;228(6):712.e1-712.e16. doi: 10.1016/j.ajog.2023.03.020. Epub 2023 Mar 17.
- 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 transvaginal ultrasonography, monophasic combined oral contraceptive pill and 52 mg levonorgestrel-releasing intrauterine system in people with Abnormal Uterine Bleeding and Cesarean Section Complications, 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 3 inclusion and 11 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 20 Feb 2026. 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. 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?
The change in the total number of postmenstrual and/or intermenstrual spotting days per cycle at 6 months post randomization from baseline. (time frame: at baseline and at 6 months post randomization). 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 NCT07229209, which also lists 14 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 20 Feb 2026.