New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT

Not Applicable

Recruiting

Conditions: First Trimester Abortion
Miscarriage With Afibrinogenemia
Surgical Abortion

Brief Summary: The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage.

* To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients.

* To examine the rate of complications or side effects with the NCH gel.

* To assess the subsequent menstrual history and reproductive outcome in both groups of patients.

Detailed Description: There is limited data to evaluate the incidence of IUA after using this NCH gel in patients undergoing surgical evacuation via USG-MVA for the treatment of first-trimester miscarriage. Previous RCT showed a significant reduction in IUA with the use of NCH gel, with IUA detected in only 9.5% of patients with NCH gel applied compared to 24.1% in the control group. However, the group did not involve patients undergoing surgical evacuation by USG-MVA.

Therefore, the objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment of first-trimester miscarriage.

Recruitment & Eligibility

Inclusion Criteria

Women 18 years old or above
No previous history of IUA/ Asherman's syndrome
No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
No previous history of therapeutic hysteroscopic surgeries
Voluntary informed consent and understanding of study

Exclusion Criteria

previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
suspicion of molar pregnancy
genital tract malformation
suspicion of active infection or genital tract malignancy or genital tuberculosis
abnormal blood coagulation
inability to tolerate pelvic examination known
suspected intolerance of hypersensitivity to NCH gel or its derivatives
patient refusal

Arm && Interventions

Group	Intervention	Description
Intervention group (Group A): NCH gel after USG-MVA	MateRegen® gel (BioRegen)	In the intervention group (Group A), a 15 cm sterile delivery cannula will be inserted through the internal os and a syringe of NCH gel (5ml) will be applied to the uterine cavity after cleansing the cervix with an antiseptic solution.

Primary Outcome Measures

Name	Time	Method
Incidence of IUA	8-12 weeks after MVA	To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.

Secondary Outcome Measures

Name	Time	Method
Subsequent reproductive outcome	8-12 weeks after MVA	To assess the rate of pregnancy in both groups of patients
Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score	8-12 weeks after MVA	To study the severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score in both groups of patients. The American Fertility Society's (AFS) classification of intrauterine adhesions: Stage I (mild) with score 1-4, Stage II (moderate) with score 5-8, Stage III (severe) with score 9-12
Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score	8-12 weeks after MVA	To study the severity and extent of the intrauterine adhesions as assessed by the European Society of Gynaecological Endoscopy (ESGE) adhesion score in both groups of patients. It includes grades I and II as mild adhesion, grade III as moderate adhesion, grades IV and V as severe adhesion
Complications or side effects with the NCH gel.	8-12 weeks after MVA	To examine the rate of complications or side effects with the NCH gel.
Subsequent menstrual frequency	8-12 weeks after MVA	To assess the subsequent menstrual frequency in both groups of patients. Frequency - average 28 days \<24 days Frequent, \>38 days Infrequent Frequency - average 28 days \<24 days Frequent, \>38 days Infrequent