Abnormal Uterine Bleeding, Cesarean Section Complications, Scar Niche
Conditions
Keywords
Misoprostol, Administration, Sublingual, Cervical Priming, Hysteroscopy, Cesarean Section Scar Defect, Randomized Controlled Trial, Postmenstrual Spotting
Brief summary
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.
Detailed description
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.
Interventions
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.
OTHERPlacebo tab
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.
PROCEDUREHysteroscopic resection of uterine niche
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.
DIAGNOSTIC_TESTSaline-infusion Sonohysterography
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* ≥1 previous cesarean section * Post cesarean section uterine niche confirmed by saline infusion sonohysterography (niche depth ≥2 mm) * Residual myometrial thickness ≥2.5 mm as confirmed by saline infusion sonohysterography * Regular cycles * Abnormal uterine bleeding for ≥3 consecutive cycles * Post menstrual spotting or brownish discharge ≥2 days * Total monthly bleeding duration \>7 days
Exclusion criteria
* Irregular cycles * Amenorrhea * Abnormal cervical cytology * Acute or chronic cervicitis * Pelvic inflammatory disease * Endometrial polyps * Uterine fibroids * Contraindications to spinal or general anesthesia * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in number of days of postmenstrual spotting. | At 3 months postoperative. | The number of days of postmenstrual spotting was recorded at baseline and 3 months post hysteroscopic resection of uterine niche. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic pain score | At baseline and at 3 months postoperative. | 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. |
| Dysmenorrhea score | At baseline and at 3 months postoperative. | 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. |
| Dyspareunia score | At baseline and at 3 months postoperative. | 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. |
| Total bleeding days per cycle | At baseline and at 3 months postoperative. | Total bleeding days per cycle was recorded at baseline and 3 months post hysteroscopic resection of uterine niche. |
| Satisfaction with the outcome | At 3 months postoperative. | Participant satisfaction with the outcome was assessed using a binary scale (Yes when satisfied/very satisfied , No when dissatisfied/neutral). |
| Uterine niche measurements | At baseline and at 3 months postoperative. | 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. |
| Dysuria score | At baseline and at 3 months postoperative. | 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. |
Countries
Egypt
Outcome results
None listed