The purpose of the study is to evaluated whether preoperative sublingual misoprostol can enhance the effectiveness and safety of niche resection in patients with symptomatic uterine niche.
After eligibility and consenting, Participants with symptomatic uterine niche were randomized (1:1) to sublingual misoprostol or placebo. Baseline demographic and clinical variables (age, BMI, number of prior cesarean section, number of days of postmenstrual spotting, pelvic pain, dysmenorrhea, dyspareunia, and dysuria) were collected. Symptom severity was assessed using a visual analogue scale (VAS, 1-10). Baseline niche characteristics (residual myometrial thickness, depth, length, and width) were measured by saline infusion sonohysterography. The misoprostol group received 200 µg sublingual misoprostol tablet two hours before surgery; controls received identical placebo tablets. Hysteroscopic resection of uterine niche was performed around cycle day 10 under spinal or general anesthesia using a 9-mm resectoscope with monopolar energy and 3.5% sorbitol for uterine distension. Misoprostol-related adverse events (cramping, fever, GI upset) were recorded preoperatively by a trained nurse. The Sanders and Murji technique was adapted as follow: (1) anatomical orientation, (2) cephalic rim resection, (3) caudal rim resection, and (4) rollerball ablation of the niche base . Intraoperative data (duration, need for dilators, intra- and postoperative complications). At 3 months postoperatively, participants were reassessed for reduction in number of days of postmenstrual spotting, changes in pelvic pain, dysmenorrhea, dyspareunia, and dysuria (VAS scores), participants satisfaction (satisfied/very satisfied vs. dissatisfied/neutral), , and sonohysterographic niche measurements (RMT, depth, length, width). The participants, hysteroscopist, outcome assessors, and the investigator were blinded for the assignment of the participants to either groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Misoprostol group received 200 µg sublingual misoprostol tablet two hours before hysteroscopic resection of uterine niche. A trained nurse, independent of assessment, prepared and administered the medication to the participants.
Placebo group received sublingual identical tablet two hours before hysteroscopic resection of uterine niche. A trained nurse, independent of assessment, prepared and administered the tab to the participants.
Procedures were performed around cycle day 10 under spinal or general anesthesia using a 9-mm resectoscope (Karl Storz, Germany) with monopolar energy and 3.5% sorbitol for uterine distension. The Sanders and Murji technique was adapted as follow: (1) anatomical orientation, (2) cephalic rim resection, (3) caudal rim resection, and (4) rollerball ablation of the niche base.
Benha Univesity Hospital
Banhā, Qalyubia Governorate, Egypt
Reduction in number of days of postmenstrual spotting.
The number of days of postmenstrual spotting was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.
Time frame: At 3 months postoperative.
Total bleeding days per cycle
Total bleeding days per cycle was recorded at baseline and 3 months post hysteroscopic resection of uterine niche.
Time frame: At baseline and at 3 months postoperative.
Pelvic pain score
Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.
Time frame: At baseline and at 3 months postoperative.
Dysmenorrhea score
Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.
Time frame: At baseline and at 3 months postoperative.
Dyspareunia score
Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.
Time frame: At baseline and at 3 months postoperative.
Dysuria score
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All participants were evaluated by a single blinded sonographer experienced in niche assessment. First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.
Pain was assessed using a 10-cm Visual Analog Scale (VAS). Participants mark a point on the line that represents their pain,giving that 0 means no pain and 10 means worst pain imaginable. The clinician measures the distance (in centimeters or millimeters) from 0 to the patient's mark and that number is the VAS pain score.
Time frame: At baseline and at 3 months postoperative.
Satisfaction with the outcome
Participant satisfaction with the outcome was assessed using a binary scale (Yes when satisfied/very satisfied , No when dissatisfied/neutral).
Time frame: At 3 months postoperative.
Uterine niche measurements
First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.
Time frame: At baseline and at 3 months postoperative.