To determine whatdose of medicineis needed to open the cervix adequately

Comparison of efficacy of vaginal misoprostol 100 micrograms versus 200 micrograms for cervical priming prior to operative hysteroscopy â?? a randomized control trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027122

Enrollment

Registered

2020-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: 100MCG MISOPROSTOL: The patients will be allocated into 2 groups, Group I low dose 100mcg misoprostol ,Group II high dose 200mcg misoprostol, via a computer-generated randomization list

Eligibility

Inclusion criteria

Inclusion criteria: Patients requiring operative hysteroscopy for intrauterine cavitory pathologies based on transvaginal ultrasound.

Exclusion criteria

Exclusion criteria: 1. Contraindications to hysteroscopy (i.e. pregnancy, cervical malignancy, recent or recurrent pelvic inflammatory disease, marked cervical stenosis, profuse uterine bleeding or recent uterine perforation etc.) 2. Any possible contraindications to use of prostaglandins (known sensitivity to prostaglandins, cardiovascular disease, renal failure, severe bronchial asthma, glaucoma etc.) 3. Previous cervical surgery 4. Presence of significant uterovaginal prolapse impairing vaginal administration. 5. Unmarried women where administration of vaginal misoprostol cannot be done.

Design outcomes

Primary

Measure	Time frame
Baseline cervical width at the beginning of the procedure assessed by the largest number of Hegar dilator that could be inserted into the cervix without resistance.Timepoint: After giving anaesthesia,at the beginning of the procedure .	—

Secondary

Measure	Time frame
1) Ease of entry of the hysteroscope into the cervix recorded on a 5-point Likert scale: very difficult, difficult, fair, easy, and very easy. 2) Adverse effects of misoprostol administration (Nausea, vomiting, abdominal pain, diarrhea, fever, shivering, skin rash, vaginal spotting). 3) Complications of the procedure (cervical laceration, uterine perforation, false track, bleeding, infection) Timepoint: 1) Ease of entry - Will be assessed by the operating surgeon at the beginning of the procedure and recorded after surgery in the proforma. 2)Adverse effects - In the control desk, before the operation, the patients will be interviewed . 3) Complications -Will be assessed at two different time points - First -Once the operation is complete, the surgeon will fill any incidences of complications in the Performa. Second - Prior to discharge on the same day.	—

Measure

Time frame

1) Ease of entry of the hysteroscope into the cervix recorded on a 5-point Likert scale: very difficult, difficult, fair, easy, and very easy. 2) Adverse effects of misoprostol administration (Nausea, vomiting, abdominal pain, diarrhea, fever, shivering, skin rash, vaginal spotting). 3) Complications of the procedure (cervical laceration, uterine perforation, false track, bleeding, infection) Timepoint: 1) Ease of entry - Will be assessed by the operating surgeon at the beginning of the procedure and recorded after surgery in the proforma. 2)Adverse effects - In the control desk, before the operation, the patients will be interviewed . 3) Complications -Will be assessed at two different time points - First -Once the operation is complete, the surgeon will fill any incidences of complications in the Performa. Second - Prior to discharge on the same day.

—

Countries

India

Contacts

Public ContactDr Aida Merin Finny

Christian Medical College Vellore

anillilly93@gmail.com9486201559

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026