Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Dinoprostone Timing

Treatments: Drug: short interval dinoprostone; Drug: long interval dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT04085757

dinoprostone timing

Details and patient eligibility

About

The aim of this study is to determine whether dinoprostone administered 10 hours before office hysteroscopy can relieve pain more effectively compared with dinoprostone administered 3 hours before office hysteroscopy.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nulliparous patients who have an indication for office hysteroscopy

Exclusion criteria

• Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, allergy to dinoprostone

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups

long interval dinoprostone

Experimental group

Description:

A small envelope including two labeled plastic bags (A \& B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.

Treatment:

Drug: long interval dinoprostone

short interval dinoprostone

Active Comparator group

Description:

A small envelope including two labeled plastic bags (A\& B) (each bag containing either 1 dinoprostone tablets(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.

Treatment:

Drug: short interval dinoprostone