postmenstrual bleeding
Conditions
Interventions
LNG group
Sponsors
suez canal university
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Patients aged between 20 and 45 years - Women with a previous caesarean section (at least one previous cesarean delivery) - postmenstrual spotting of at least two days and in whom ultrasound had shown a niche, they are considered to undergo a hysteroscopic niche resection or to receive LNG-IUD (52 mg) insertion.
Exclusion criteria
Exclusion criteria: - Fertility wish within 1 year - Irregular menstrual cycle before the last cesarean delivery, - Presence of an intrauterine device - Coagulopathy - The length of the uterine cavity less than 6 cm or more than 10 cm - Current exogenous hormone treatment - Other gynecological conditions that could cause prolonged bleeding such as leiomyoma, endometrial hyperplasia, ovarian endometriosis and pregnancy - Patients had received hysteroscopic resection or LNG-IUD before intervention - In hysteroscopy group, additional exclusion criteria are contraindication for general anesthesia and with residual myometrium thickness (RMT) less than 2.2 mm to prevent bladder injury and uterine perforation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reducing spotting days at the 6th month after treatment based on the intention-to-treat (ITT) analyses. We also will analyze the effectiveness rate (defined as proportion of patients with spotting days reduced by at least 50% from baseline), menstrual characteristics (e.g., duration of menstruation, total bleeding days per month, amenorrhea is defined as no menstruation/irregular bleeding or spotting for at least 3 months, patients’ satisfaction of menstruation (5-point Likert scale) and direct medical costs (including the costs of preoperative examination, medical consumption and the surgery) at each follow-up point based on both ITT and per protocol analyses. If additional LNG-IUD is applied in hysteroscopy group or if an IUD is removed in LNG-IUD group because of symptoms, it will be considered as a failure. Pregnant women will be deleted from the study starting with the cycle of conception. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative complications will be recorded in the Electronic Medical Record. Postoperative complications and side effects will be evaluated using digital questionnaires, these included questions on urinary tract injury, fever, infection, breast pain, pelvic pain, emotional wings, depression, weight changes and acne. side effects of LNG-IUS | — |
Countries
Egypt
Contacts
Public Contacthanan ghoneim
suez canal university
Outcome results
None listed