Cesarean Section ComplicationsPhase 2/3NCT04307524
Laparoscopic Repair of Cesarean Scar Niche
A Phase 2/3 study testing laparoscopic repair and medical treatment in the form of combined hormonal contraception in people with Cesarean Section Complications, run by Zagazig University.
Trial summary
Evaluation of laparoscopy repair of cesarean scar niche in resolution of symptoms related to niche as compared to expectant management. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- laparoscopic repair and medical treatment in the form of combined hormonal contraception
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2020to 30 Mar 2021
- Phase
- Phase 2/3
- 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
- History of cesarean section.
- Postmenstrual and/or intermenstrual spotting.
- Cesarean scar niche of at least 2 mm in depth diagnosed by saline infusion sonography
Who cannot join
- pregnancy
- Uterine anomalies
- Hysterotomy.
- history Placenta previa and MAP
- Upper segment incision, Vertical uterine incision
- submucosal fibroids
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- adenomyosis.
- History atypical endometrial cells, cervical dysplasia,
- cervical or pelvic infection.
- Irregular cycle.
- lactation amenorrhea.
About this study
Official title: Laparoscopic Repair Of Cesarean Scar Niche: Randomized Controlled Trial.
Evaluation of laparoscopy repair of cesarean scar niche in resolution of symptoms related to niche as compared to expectant management.
Read the detailed description
Recently, The percentage of Cesarean section (CS) deliveries has dramatically increased in most countries. The presence of a niche at the site of a CS scar has been observed. A niche is mainly a sonographic finding defined as a triangular anechoic area at site of incision. ( Mascarello et al, 2017) Alternative terms for a niche are Cesarean scar defect (Wang et al, 2009), deficient Cesarean scar (Ofili-Yebovi et al, 2008), diverticulum (Surapaneni et al, 2008), pouch (Fabres el al, 2003) and isthmocele. (bogres el al, 2010) As not all women with previous CS develop a niche, it is a matter of interest to identify the risk factors that may predict their development. (Sholapurkar , 2018) Possible causes of this condition may be surgery or patient related. Surgery related factors as low cervical incision, incomplete closure of the uterus (decidual sparing) and inadequate hemostasis. Patient related factors may be attributed to infection. ( Vervoort et al, 2015) Cesarean scar niche may be asymptomatic or may cause a number of obstetrical and gynecological problems (cesarean scar syndrome) . ( Vervoort et al,2015b) Obstetrical complications of the niche are cesarean scar ectopic pregnancy, placenta previa and morbidly adherent placenta, cesarean scar dehiscence following incomplete abortion secondary to uterotonic drugs, Scar dehiscence and tender scar even scar rupture (Tanimura el al, 2015) Gynecological symptoms of the niche are postmenstrual spotting, Intermenstrual bleeding, Dysmenorrheal, Dysparunia and secondary infertility. (Tanimura el al, 2015) Various methods to detect and measure a niche have been described. The majority of papers have evaluated the niche with the use of transvaginal sonography (TVS) (Vaate et al, 2011), and contrast-enhanced sonohysterography (SHG) (Bij de Vaate et al, 2011), but a minority have used hysteroscopy (El-Mazny et al, 2011) or hysterosalpingography. (Surapaneni and Silberzweig, 2008 ) At present there is no consensus regarding the gold standard for the detection and measurement of a niche. (Vaate et al, 2014) Symptomatic cesarean scar niche (cesarean scar syndrome) can be managed conservatively using combined oral contraceptive pills especially in women not seeking fertility, or it can be treated using minimal invasive surgery as hysteroscopic resection (vervoot et al,2017) , laparoscopic repair (ma et al,2017) or vaginal repair (Yao, 2014) In this study we will evaluate laparoscopic management of cesarean scar niche
- Conditions
- Cesarean Section Complications
- Being tested
- laparoscopic repair, medical treatment in the form of combined hormonal contraception
- Keywords
- cesarean scar niche
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic repairProcedure or surgery
laparoscopic suture repair of cesarean scar niche
medical treatment in the form of combined hormonal contraceptionDrug
patient will receive for three months daily without interruption, no pill-free interval drug names is "Genera" BAYERhealthcare
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic repair | Experimental | suture repair of cesarean scar niche using laparoscopy Receives: Procedure: laparoscopic repair |
| medical treatment | Active comparator | conservative management Receives: Drug: medical treatment in the form of combined hormonal contraception |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-menstrual spotting
number of days of post-menstrual spotting "spotting or bleeding after 8 days of menstruation whatever the amount
Measured: 6 month after intervention
Secondary outcomes (2)
menstrual related pain
degree of menstrual related pain as descriped by the patient on Visual Analogue Scale of pain from 1 to 10
Measured: 6 month after intervention
infertility
failure of conception despite regular sexual intercourse within 6 months from intervention or stopping gynera
Measured: 6 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start15 Mar 2020 (estimated)
- Primary completion15 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Zagazig 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mahmoud Ismail Abdel Rahman Kotb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307524
- Sponsor's protocol ID
- cesarean scar niche
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2020
- Last updated
- 13 Mar 2020
- 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 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Repair Of Cesarean Scar Niche: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04307524
- Acronym / sponsor ID
- cesarean scar niche
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean scar niche
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 13 Mar 2020 (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.
Evaluation of laparoscopy repair of cesarean scar niche in resolution of symptoms related to niche as compared to expectant management.
Detailed description
Recently, The percentage of Cesarean section (CS) deliveries has dramatically increased in most countries. The presence of a niche at the site of a CS scar has been observed. A niche is mainly a sonographic finding defined as a triangular anechoic area at site of incision. ( Mascarello et al, 2017) Alternative terms for a niche are Cesarean scar defect (Wang et al, 2009), deficient Cesarean scar (Ofili-Yebovi et al, 2008), diverticulum (Surapaneni et al, 2008), pouch (Fabres el al, 2003) and isthmocele. (bogres el al, 2010) As not all women with previous CS develop a niche, it is a matter of interest to identify the risk factors that may predict their development. (Sholapurkar , 2018) Possible causes of this condition may be surgery or patient related. Surgery related factors as low cervical incision, incomplete closure of the uterus (decidual sparing) and inadequate hemostasis. Patient related factors may be attributed to infection. ( Vervoort et al, 2015) Cesarean scar niche may be asymptomatic or may cause a number of obstetrical and gynecological problems (cesarean scar syndrome) . ( Vervoort et al,2015b) Obstetrical complications of the niche are cesarean scar ectopic pregnancy, placenta previa and morbidly adherent placenta, cesarean scar dehiscence following incomplete abortion secondary to uterotonic drugs, Scar dehiscence and tender scar even scar rupture (Tanimura el al, 2015) Gynecological symptoms of the niche are postmenstrual spotting, Intermenstrual bleeding, Dysmenorrheal, Dysparunia and secondary infertility. (Tanimura el al, 2015) Various methods to detect and measure a niche have been described. The majority of papers have evaluated the niche with the use of transvaginal sonography (TVS) (Vaate et al, 2011), and contrast-enhanced sonohysterography (SHG) (Bij de Vaate et al, 2011), but a minority have used hysteroscopy (El-Mazny et al, 2011) or hysterosalpingography. (Surapaneni and Silberzweig, 2008 ) At present there is no consensus regarding the gold standard for the detection and measurement of a niche. (Vaate et al, 2014) Symptomatic cesarean scar niche (cesarean scar syndrome) can be managed conservatively using combined oral contraceptive pills especially in women not seeking fertility, or it can be treated using minimal invasive surgery as hysteroscopic resection (vervoot et al,2017) , laparoscopic repair (ma et al,2017) or vaginal repair (Yao, 2014) In this study we will evaluate laparoscopic management of cesarean scar niche
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| laparoscopic repair | Experimental | Procedure: laparoscopic repairsuture repair of cesarean scar niche using laparoscopy |
| medical treatment | Active comparator | Drug: medical treatment in the form of combined hormonal contraceptionconservative management |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of cesarean section.
- Postmenstrual and/or intermenstrual spotting.
- Cesarean scar niche of at least 2 mm in depth diagnosed by saline infusion sonography
Key exclusion criteria (11 listed)
- pregnancy
- Uterine anomalies
- Hysterotomy.
- history Placenta previa and MAP
- Upper segment incision, Vertical uterine incision
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 |
|---|---|---|
| laparoscopic repairlaparoscopic suture repair of cesarean scar niche | Procedure or surgery | laparoscopic repair |
| medical treatment in the form of combined hormonal contraceptionpatient will receive for three months daily without interruption, no pill-free interval drug names is "Genera" BAYERhealthcare | Drug | medical treatment |
Primary outcome
post-menstrual spotting
Time frame: 6 month after intervention
number of days of post-menstrual spotting "spotting or bleeding after 8 days of menstruation whatever the amount
2 secondary outcomes
menstrual related pain
Time frame: 6 month after intervention
infertility
Time frame: 6 month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing laparoscopic repair and medical treatment in the form of combined hormonal contraception in people with Cesarean Section Complications, run by Zagazig University.
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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
post-menstrual spotting (time frame: 6 month after intervention). 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 13 Mar 2020.