Do 2005.
Methods | Parallel‐group randomised controlled trial. Single centre, Hallym University Kangdong Sacred Heart Hospital, Seoul, South Korea. Protocol approved by IRB: not reported; no contact possible due to absence of contact details. Statistical power calculation not reported; no contact possible due to absence of contact details. External funding and conflicts of interest not reported; no contact possible due to absence of contact details. |
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Participants | Number recruited: 64 women. Number randomly assigned: 64 women. Number excluded: 2 women, reason for exclusion not reported. Number lost to follow‐up: 0 women. Number analysed: 62 women. Inclusion criterion:
Exclusion criteria:
Proportion of women with infertility: unclear if infertile women were included or excluded. Study duration of study: 10 months. Mean age (range): 28 (22‐43) years. Mean age in intervention group: 26 years. Mean age in control group: 31 years. |
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Interventions |
HA/CMC gel (intervention: n = 32) vs saline (control: n = 30) Intervention group: after intrauterine surgery, 10 mL of HA + CMC applied on uterine cavity. Control group: 10 mL of saline applied. After surgery, antibiotics injected for 1 day, and then oral antibiotics administered for 3 days. Women who underwent dilatation and curettage were discharged on 1st postoperative day, and women who underwent hysteroscopy were discharged on 2nd postoperative. |
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Outcomes | Frequency and severity of IUAs compared by microhysteroscopy on 4th postoperative week, severity of IUAs classified in accordance with AFS 1988 guidelines. | |
Notes | No contact data of the primary study authors reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomized to 32 patients of study group (group A) and 32 patients of control group (group B) each." Comment: method not described; unclear if stratified randomisation was used; no contact possible. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described; no contact possible. |
Blinding of participants and personnel (performance bias) Live birth, pregnancy or miscarriage | Low risk | Quote: "After intrauterine surgery, in group A [intervention], 10ml of Hyaluronic acid + Sodium Carboxymethyl Cellulose (HA + CMC) was applied on uterine cavity, and in group B [control], 10ml of saline was applied." Comment: surgeons not blinded; easy to distinguish saline from gel. |
Blinding of participants and personnel (performance bias) Adhesions | High risk | Quote: "After intrauterine surgery, in group A, 10ml of Hyaluronic acid + Sodium Carboxymethyl Cellulose (HA + CMC) was applied on uterine cavity, and in group B, 10ml of saline was applied." Comment: surgeons not blinded; easy to distinguish saline from gel. |
Blinding of outcome assessment (detection bias) Live birth, pregnancy or miscarriage | Low risk | Not reported if gynaecologists who performed second‐look procedure 4 weeks after surgery were blinded or not; no contact possible. |
Blinding of outcome assessment (detection bias) Adhesions | Unclear risk | Not reported if gynaecologists who performed second‐look procedure 4 weeks after surgery were blinded or not; no contact possible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "In total 64 patients, 62 patients were followed up postoperatively. Group A was 32 patients, Group B was 30 patients, and 2 patients were excluded during study." Comment: reasons for postrandomisation exclusion not reported. |
Selective reporting (reporting bias) | Low risk | Comment: no evidence of selective outcome reporting when abstract, methods and results were compared. |
Other bias | High risk | Quote: "See table of baseline characteristics Age in years group A [intervention]: 26 Age in years group B [control]: 31 Parity in group A: 0.8 Parity in group B: 1.5 Abortion in group A: 1.0 Abortion in group B: 1.8." Comment: high risk of selection bias. Quote: "As a result of transvaginal sonography, intrauterine adhesion was observed at 4 patients (13%) out of 32 patients in group A and had mild intrauterine adhesions." Comment: unclear if micro‐hysteroscopy or transvaginal ultrasound used for outcome assessment of IUAs. High risk of information bias. |