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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
Show all 11Show fewer
  • 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

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 groups in NCT04307524
Study groupRoleWhat they receive
laparoscopic repairExperimentalsuture repair of cesarean scar niche using laparoscopy
Receives: Procedure: laparoscopic repair
medical treatmentActive comparatorconservative 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted13 Mar 2020
  2. Study start15 Mar 2020 (estimated)
  3. Primary completion15 Mar 2021 (estimated)
  4. Study completion30 Mar 2021 (estimated)

Resources

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)
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

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.

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