NCT05358678

Cesarean Section Scar Niche: The Impact on ART Outcome

Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 266 (estimated)
• Sponsor: Rahem Fertility Center · Academic / Other
• Sex: Female
• Age: 18 Years – 37 Years
• Healthy volunteers: —

Summary

To evaluate the impact of the presence of cesarean section niche and its characteristics on the outcome of ART cycles.

Detailed description

The incidence of Cesarean section (CS) is increasing worldwide, with a corresponding increase in its associated complications. The well-known complications are infection, hemorrhage, and increased risk of obstetric complications in subsequent pregnancies, like morbidly adherent placenta, cs scar pregnancies and uterine rupture. In addition, some studies emphasize the effect of cesarean sections on reduced fertility. A meta-analysis reported that a Caesarean section reduces the probability of subsequent pregnancy by 10%, compared with a previous vaginal delivery. The cesarean section niche is defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding. Meanwhile, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility. The detection of a cesarean section niche depends on the operator and the diagnostic method used. This can be 2D, 3D transvaginal sonography, sonohysterography or hysteroscopy. Regarding ART, the presence of cs niche was reported to reduce the chances of embryo implantation, and increase the rate of spontaneous miscarriages, especially if the implantation is close to it or in the niche. The presence of a niche may increase the difficulty of embryo transfer procedure, clinicians need to be aware of its presence and the transfer should be done under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.

Conditions

• Cesarean Section
• ART

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cs niche group	A niche is formally defined by the European Niche Taskforce as an indentation of the uterine myometrium of at least 2 mm at the site of the CS scars. A niche can be sub classified as follows: 1. Simple niche 2. Simple niche with one branch 3. Complex niche (with more than one branch). The following measurements will be taken: * Length. * Depth. * Width. * RMT (residual myometrium thickness). * AMT (adjacent myometrium thickness). * Distance between the niche and the VV (vesico-vaginal) fold. * Distance between the niche and the external os. We will also comment on the position of the uterus (AVF or RVF), presence or absence of intra cavitary fluid and its thickness.

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2022-05-03
• Last updated: 2022-10-26

Locations

1 site across 1 country: Egypt