Intermenstrual BleedingNCT05594186
Nonsurgical Management of Cesarean Scar Niche Related Abnormal Uterine Bleeding
A study testing Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system. in people with Intermenstrual Bleeding, run by Saudi German Hospital - Madinah at 1 site in Saudi Arabia.
Trial summary
A study of the effect of three different nonsurgical methods for management of abnormal uterine bleeding caused by cesarean scar niche. The study was conducted at the Obstetrics and Gynaecology department of the Saudi German Hospital in Madinah- Saudi Arabia, during the period between March 2019 to October 2022. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Intermenstrual Bleeding
- What is being tested?
- Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2019to 20 Oct 2022
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The study included 158 patients aged between 20 and 40 years who had a history of at least one caesarean delivery and presented with abnormal uterine bleeding in the form of postmenstrual spotting defined as bloody or brownish discharge of more than two days after the end of menstruation, with the total duration of (menses and spotting) of more than 7 days, or intermenstrual bleeding that starts after the end of the menses, who were diagnosed to have a caesarean scar niche by saline infusion sonography. Cesarean scar niche was defined as an anechoic triangular indentation at the site of the previous cesarean scar with a depth of at least 2 mm. Saline infusion sonography was done, in which instillation of saline solution into the uterine cavity, enhanced the transvaginal ultrasonographic image by providing a sonolucent contrast medium to allow for better visualization and delineation of the defect. Evaluation was performed according to the 2019 modified Delphi procedure where the basic evaluation of CS niche included measurements of the length, depth and width of the defect, the residual myometrial thickness (RMT) and the adjacent myometrial thickness (AMT). All measurements were made in the sagittal plane except the width which was measured in the transverse plane. The 4.5 MHz endovaginal transducer was used.
Who cannot join
- Exclusion criteria were: pregnancy, desire for fertility within one year of enrolment in the study, any medical condition contraindicating the use of combined oral contraceptive pills, history of abnormal uterine bleeding dating before the last caesarean section, use of any hormonal treatment 3 months prior to enrolment, coagulopathy, and organic causes of bleeding like uterine fibroids, adenomyosis or endometrial hyperplasia.
Trial locations and contacts
1 site in 1 country.
About this study
A study of the effect of three different nonsurgical methods for management of abnormal uterine bleeding caused by cesarean scar niche. The study was conducted at the Obstetrics and Gynaecology department of the Saudi German Hospital in Madinah- Saudi Arabia, during the period between March 2019 to October 2022. The study protocol was in accordance with the Helsinki declaration 1964 and the later amendments. A prospective approval was granted by the human research ethics committee of the hospital and the study participants have signed an informed consent.
Read the detailed description
The study included 158 patients aged between 20 and 40 years who had a history of at least one caesarean delivery and presented with abnormal uterine bleeding in the form of postmenstrual spotting defined as bloody or brownish discharge of more than two days after the end of menstruation, with the total duration of (menses and spotting) of more than 7 days, or intermenstrual bleeding that starts after the end of the menses, who were diagnosed to have a caesarean scar niche by saline infusion sonography. Cesarean scar niche was defined as an anechoic triangular indentation at the site of the previous cesarean scar with a depth of at least 2 mm. Exclusion criteria were: pregnancy, desire for fertility within one year of enrolment in the study, any medical condition contraindicating the use of combined oral contraceptive pills, history of abnormal uterine bleeding dating before the last caesarean section, use of any hormonal treatment 3 months prior to enrolment, coagulopathy, and organic causes of bleeding like uterine fibroids, adenomyosis or endometrial hyperplasia. Saline infusion sonography was done, in which instillation of saline solution into the uterine cavity, enhanced the transvaginal ultrasonographic image by providing a sonolucent contrast medium to allow for better visualization and delineation of the defect. Evaluation was performed according to the 2019 modified Delphi procedure where the basic evaluation of CS niche included measurements of the length, depth and width of the defect, the residual myometrial thickness (RMT) and the adjacent myometrial thickness (AMT). All measurements were made in the sagittal plane except the width which was measured in the transverse plane. The 4.5 MHz endovaginal transducer (Canon Xario 200G Ultrasound, Japan) was used.
Using an Open Epi version 3.21 computer-based software, patients were divided into four groups (A, B, C and D). Patients in group A, received Tranexamic acid 1300 mg (2 tablets of 650 mg) three times daily for 5 days starting from the first day of menses for 12 months. Patients in group B, received combined oral contraceptive pill (OCP) once daily for 21 days starting from the first day of menses, then to have a one-week pill free period to allow for a withdrawal bleed, and that was repeated for 12 cycles. Patients in group C, received a combination of Tranexamic acid 1300 mg three times daily for 5 days, and a combined oral contraceptive pill once daily for 21 days, both starting from the first day of menses for 12 consecutive cycles. Patients in group D, had the levonorgestrel-releasing intrauterine system inserted into the uterine cavity. The insertion was done by a skilled gynecologist as an outpatient procedure without anesthesia. The possible long- and short-term side effects of the different interventions were carefully discussed with all patients, and those who were willing to participate had signed the informed consent before participation. The primary outcome was the improvement of postmenstrual spotting as reported by the patients in their menstrual diary at each of the follow up visits (three, six, nine and twelve months) after enrolment in the study.
The participants were asked to complete the menstrual diary card that was designed based on that used in the study of Johannes and colleagues in 1996. The illustrated symbols at the top of the card indicated the heaviness of menstrual bleeding (flooding, heavy, normal, light or spotting) and the names of the months were written on the left side of the card.
- Conditions
- Intermenstrual Bleeding
- Being tested
- Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.Drug
Comparing three different nonsurgical management options for abnormal uterine bleeding caused by cesarean scar niche.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | Patients in group A, received Tranexamic acid 1300 mg (2 tablets of 650 mg) three times daily for 5 days starting from the first day of menses for 12 months. Receives: Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system. |
| Combined oral contraceptive pill | Active comparator | Patients in group B, received combined oral contraceptive pill (OCP) once daily for 21 days (Desogestrel 150 micrograms/ Ethinylestradiol 30 micrograms, tablets), starting from the first day of menses, then to have a one-week pill free period to allow for a withdrawal bleed, and that was repeated for 12 cycles. Receives: Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system. |
| Tranexamic acid plus Combined oral contraceptive pill | Active comparator | Patients in group C, received a combination of Tranexamic acid 1300 mg three times daily for 5 days, and a combined oral contraceptive pill once daily for 21 days (Desogestrel 150 micrograms/ Ethinylestradiol 30 micrograms, tablets), both starting from the first day of menses for 12 consecutive cycles. Receives: Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system. |
| Levonorgestrel-releasing intrauterine system | Active comparator | Patients in group D, had the levonorgestrel-releasing intrauterine system inserted into the uterine cavity. The insertion was done by a skilled gynecologist as an outpatient procedure without anesthesia. Receives: Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of post-menstrual spotting
Improvement of post-menstrual spotting as reported by the patients in their menstrual diary at each of the follow up visits (three, six, nine and twelve months) after enrolment in the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Mar 2019
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermenstrual BleedingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saudi German Hospital - Madinah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mohamed Magdi Ammar, Saudi German Hospital - Madinah
- Investigators
- Islam Mohamed Magdi Ammar, M.D., Principal investigator, Saudi German Hospital - Madinah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594186
- Sponsor's protocol ID
- SGHM-FEB2019-OBGYN
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonsurgical Management of Cesarean Scar Niche Related Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT05594186
- Acronym / sponsor ID
- SGHM-FEB2019-OBGYN
- Conditions
- Intermenstrual Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Saudi German Hospital - MadinahUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 26 Oct 2022 (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.
A study of the effect of three different nonsurgical methods for management of abnormal uterine bleeding caused by cesarean scar niche. The study was conducted at the Obstetrics and Gynaecology department of the Saudi German Hospital in Madinah- Saudi Arabia, during the period between March 2019 to October 2022. The study protocol was in accordance with the Helsinki declaration 1964 and the later amendments. A prospective approval was granted by the human research ethics committee of the hospital and the study participants have signed an informed consent.
Detailed description
The study included 158 patients aged between 20 and 40 years who had a history of at least one caesarean delivery and presented with abnormal uterine bleeding in the form of postmenstrual spotting defined as bloody or brownish discharge of more than two days after the end of menstruation, with the total duration of (menses and spotting) of more than 7 days, or intermenstrual bleeding that starts after the end of the menses, who were diagnosed to have a caesarean scar niche by saline infusion sonography. Cesarean scar niche was defined as an anechoic triangular indentation at the site of the previous cesarean scar with a depth of at least 2 mm. Exclusion criteria were: pregnancy, desire for fertility within one year of enrolment in the study, any medical condition contraindicating the use of combined oral contraceptive pills, history of abnormal uterine bleeding dating before the last caesarean section, use of any hormonal treatment 3 months prior to enrolment, coagulopathy, and organic causes of bleeding like uterine fibroids, adenomyosis or endometrial hyperplasia. Saline infusion sonography was done, in which instillation of saline solution into the uterine cavity, enhanced the transvaginal ultrasonographic image by providing a sonolucent contrast medium to allow for better visualization and delineation of the defect. Evaluation was performed according to the 2019 modified Delphi procedure where the basic evaluation of CS niche included measurements of the length, depth and width of the defect, the residual myometrial thickness (RMT) and the adjacent myometrial thickness (AMT). All measurements were made in the sagittal plane except the width which was measured in the transverse plane. The 4.5 MHz endovaginal transducer (Canon Xario 200G Ultrasound, Japan) was used.
Using an Open Epi version 3.21 computer-based software, patients were divided into four groups (A, B, C and D). Patients in group A, received Tranexamic acid 1300 mg (2 tablets of 650 mg) three times daily for 5 days starting from the first day of menses for 12 months. Patients in group B, received combined oral contraceptive pill (OCP) once daily for 21 days starting from the first day of menses, then to have a one-week pill free period to allow for a withdrawal bleed, and that was repeated for 12 cycles. Patients in group C, received a combination of Tranexamic acid 1300 mg three times daily for 5 days, and a combined oral contraceptive pill once daily for 21 days, both starting from the first day of menses for 12 consecutive cycles. Patients in group D, had the levonorgestrel-releasing intrauterine system inserted into the uterine cavity. The insertion was done by a skilled gynecologist as an outpatient procedure without anesthesia. The possible long- and short-term side effects of the different interventions were carefully discussed with all patients, and those who were willing to participate had signed the informed consent before participation. The primary outcome was the improvement of postmenstrual spotting as reported by the patients in their menstrual diary at each of the follow up visits (three, six, nine and twelve months) after enrolment in the study.
The participants were asked to complete the menstrual diary card that was designed based on that used in the study of Johannes and colleagues in 1996. The illustrated symbols at the top of the card indicated the heaviness of menstrual bleeding (flooding, heavy, normal, light or spotting) and the names of the months were written on the left side of the card.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.Patients in group A, received Tranexamic acid 1300 mg (2 tablets of 650 mg) three times daily for 5 days starting from the first day of menses for 12 months. |
| Combined oral contraceptive pill | Active comparator | Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.Patients in group B, received combined oral contraceptive pill (OCP) once daily for 21 days (Desogestrel 150 micrograms/ Ethinylestradiol 30 micrograms, tablets), starting from the first day of menses, then to have a one-week pill free period to allow for a withdrawal bleed, and that was repeated for 12 cycles. |
| Tranexamic acid plus Combined oral contraceptive pill | Active comparator | Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.Patients in group C, received a combination of Tranexamic acid 1300 mg three times daily for 5 days, and a combined oral contraceptive pill once daily for 21 days (Desogestrel 150 micrograms/ Ethinylestradiol 30 micrograms, tablets), both starting from the first day of menses for 12 consecutive cycles. |
| Levonorgestrel-releasing intrauterine system | Active comparator | Drug: Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.Patients in group D, had the levonorgestrel-releasing intrauterine system inserted into the uterine cavity. The insertion was done by a skilled gynecologist as an outpatient procedure without anesthesia. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study included 158 patients aged between 20 and 40 years who had a history of at least one caesarean delivery and presented with abnormal uterine bleeding in the form of postmenstrual spotting defined as bloody or brownish discharge of more than two days after the end of menstruation, with the total duration of (menses and spotting) of more than 7 days, or intermenstrual bleeding that starts after the end of the menses, who were diagnosed to have a caesarean scar niche by saline infusion sonography. Cesarean scar niche was defined as an anechoic triangular indentation at the site of the previous cesarean scar with a depth of at least 2 mm. Saline infusion sonography was done, in which instillation of saline solution into the uterine cavity, enhanced the transvaginal ultrasonographic image by providing a sonolucent contrast medium to allow for better visualization and delineation of the defect. Evaluation was performed according to the 2019 modified Delphi procedure where the basic evaluation of CS niche included measurements of the length, depth and width of the defect, the residual myometrial thickness (RMT) and the adjacent myometrial thickness (AMT). All measurements were made in the sagittal plane except the width which was measured in the transverse plane. The 4.5 MHz endovaginal transducer was used.
Key exclusion criteria (1 listed)
- Exclusion criteria were: pregnancy, desire for fertility within one year of enrolment in the study, any medical condition contraindicating the use of combined oral contraceptive pills, history of abnormal uterine bleeding dating before the last caesarean section, use of any hormonal treatment 3 months prior to enrolment, coagulopathy, and organic causes of bleeding like uterine fibroids, adenomyosis or endometrial hyperplasia.
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 |
|---|---|---|
| Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system.Comparing three different nonsurgical management options for abnormal uterine bleeding caused by cesarean scar niche. | Drug | Combined oral contraceptive pill, Levonorgestrel-releasing intrauterine system, Tranexamic acid, Tranexamic acid plus Combined oral contraceptive pill |
Primary outcome
Improvement of post-menstrual spotting
Time frame: 12 months
Improvement of post-menstrual spotting as reported by the patients in their menstrual diary at each of the follow up visits (three, six, nine and twelve months) after enrolment in the study.
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 26 Oct 2022.
- Individual participant dataSharing planned: No
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.
Islam Mohamed Magdi Ammar, M.D. principal investigator
Saudi German Hospital - Madinah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid, Oral contraceptive pills and the Levonorgestrel-releasing intrauterine system. in people with Intermenstrual Bleeding, run by Saudi German Hospital - Madinah at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 26 Oct 2022. 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 Saudi Arabia. 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?
Improvement of post-menstrual spotting (time frame: 12 months). 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 26 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.