To determine the association of Cesarean scar defect with abnormal menstrual patterns in women with secondary infertility.

OBJECTIVES:

   PRIMARY OBJECTIVE

To determine the association of abnormal menstrual patterns with Cesarean scar defect in women with secondary infertility.

SECONDARY OBJECTIVE

  To determine association between Cesarean scar defect size and abnormal menstrual patterns in women with secondary infertility.

.

MATERIAL AND METHODS

Study Venue: The present study will be conducted in the Department of Obstetrics & Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi.

 Type of study: Cross sectional observational study

 Duration of study: 18 months

Study population: Women with previous Cesarean delivery with secondary infertility

SAMPLE SIZE CALCULATION

Study by Hsu et al4 (2022) reported prevalence of cesarean scar defect after cesarean section in 80% patients. At 95% confidence level and taking this value as reference in women with secondary infertility with 10% Relative error, the minimum sample size estimated was 96 using the formula

             n = Zα2 p q /L2,

    Where n = sample size

            Zα = 1.96 value of the standard normal variate corresponding to level of significance alpha 5%

          p = prevalence of cesarean scar defect after cesarean section in secondary infertility women= 80%= 0.8

          q = 1 – p = 1-0.8 = 0.2

 L = relative error = 0.8*10%

n = 1.96*1.96*0.8*0.2/ (0.8*10%)2

Considering 20% attrition/non response rate, total sample size will be 120.

 

Definitions

Cesarean scar defect-The CSD will be taken as an indentation at uterine myometrium at the site of the previous cesarean section within a depth of atleast 2 mm, as per European Niche Task Force Guidelines.9

ELIGIBILITY CRITERIA

INCLUSION CRITERIA

• Women with previous Cesarean delivery with secondary infertility between age of 18 to 40 years

EXCLUSION CRITERIA

• Women with previous normal delivery with secondary infertility

• Polycystic ovarian syndrome

• Pelvic inflammatory disease

• Active genital tuberculosis

• Structural cause of AUB – Polyp, Adenomyosis, Leiomyoma, Malignancy and hyperplasia

• Nonstructural causes -Prolactinoma, thyroid disorders

METHODOLOGY

This study titled “Association of Cesarean scar defect with abnormal menstrual patterns in women with secondary infertility” is a cross sectional study that will be performed with 120 participants over 18 months duration in the Department of Obstetrics and Gynaecology, VMMC and Safdarjung Hospital, New Delhi. All women with secondary infertility with previous Cesarean section will be screened for eligibility as per inclusion and exclusion criteria. All eligible women will be enrolled in the study. Informed consent will be taken.

 After detailed history, the basic socio-demographic- clinical parameters such as age, parity, residence, socioeconomic class, height, weight, BMI, indication for CS (maternal or fetal) nature of indication (elective/emergency), number of previous CS, any post-operative complications in previous pregnancy like Postpartum hemorrhage, Surgical site infections, history of blood transfusion etc, will be recorded for each woman. All women will undergo basic infertility work-up including clinical examination and relevant investigations including pre-menstrual endometrial sampling for histopathology and Acidfast Bacilli (AFB) Culture.

The enrolled women will be assessed for Cesarean scar defect by transvaginal ultrasonography (TVUS) examination. It will be performed using a transvaginal probe of 5-9 MHz of the ultrasound machine DC-N3 (Mindray, Shenzhen, China) in postmenstrual period till 10th day of menstrual cycle. Patient will be laid in lithotomy position. Then by placing the TVUS probe under aseptic precautions, focus, depth and zoom will be adjusted. The scan will start in mid

sagittal plane. The uterus position (anteverted/retroverted) will be noted, then the plane in which niche is largest will be focused. Thereafter length, depth, and width of niche as well as residual myometrial thickness (RMT) overlying the defect will be measured. The RMT will be measured in the plane in which the RMT is thinnest; this may be different from the plane in which the niche is the largest. The transverse plane will be used for measuring the width of the niche and to identify branches. If CSD not detected by TVUS than a Saline-hystero-sonography may be done.

The menstrual pattern associated with cesarean scar defect will be assessed using FIGO AUB Classification system 1.10 Menstrual pattern will be recorded in terms of menstrual frequency, duration, regularity, and subjective impression of menstrual bleeding as experienced by the women. The abnormal menstrual pattern specifically noted will be postmenstrual spotting, intermenstrual bleeding, unscheduled bleeding and heavy menstrual bleeding. The study will also assess the association between CSD size and abnormal menstrual pattern.

Clinical definition of menstruation and menstrual cycle abbormalities will be as per FIGO AUB Classification system 1. 

The data collected will be entered in excel sheet and statistical analysis will be done.

Outcome

1. Number of women with Secondary infertility Cesarean scar.

2. To estimate correlation between Cesarean scar defect size and abnormal menstrual patterns in women with secondary infertility.