Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy

Determining the Optimal Time Interval Between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized Double-Blind Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04085757

Enrollment

180

Registered

2019-09-11

Start date

2019-09-15

Completion date

2020-01-01

Last updated

2021-05-07

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

Conditions

Dinoprostone Timing

Brief summary

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.

Interventions

DRUGlong interval dinoprostone

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.

DRUGshort interval dinoprostone

A small envelope including two labeled plastic bags (A& B) (each bag containing either 1 dinoprostone tablet(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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Intensity of pain	intraoperative	Intensity of pain by visual analog scale from 0(no pain) to 100 mm(worst pain imaginable)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026